82_FR_32107 82 FR 31976 - Medical Devices; Exemptions From Premarket Notification: Class II Devices

82 FR 31976 - Medical Devices; Exemptions From Premarket Notification: Class II Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 131 (July 11, 2017)

Page Range31976-32002
FR Document2017-14453

The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.

Federal Register, Volume 82 Issue 131 (Tuesday, July 11, 2017)
[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 31976-32002]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14453]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]


Medical Devices; Exemptions From Premarket Notification: Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a list of class II devices that the Agency has determined based on 
established factors to no longer require premarket notification to 
provide reasonable assurance of safety and effectiveness, subject to 
certain limitations. FDA is publishing this notice of that 
determination in accordance with procedures established by the 21st 
Century Cures Act. This notice represents FDA's final determination 
with respect to the list of class II devices proposed in a March 14, 
2017, Federal Register document. The exemptions in this notice will 
decrease regulatory burdens on the medical device industry and will 
eliminate private costs and expenditures required to comply with 
certain Federal regulations.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued 
a notice proposing to exempt a list of class II devices from the 
premarket notification requirements under section 510(k) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject 
to certain limitations. This notice was issued in accordance with the 
21st Century Cures Act (Pub. L. 114-255), which was signed into law on 
December 13, 2016. Section 3054 of that statute amended section 510(m) 
of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act 
provides that, within 90 days after enactment of the 21st Century Cures 
Act and at least once every 5 years thereafter, FDA must publish in the 
Federal Register a notice containing a list of each type of class II 
device that FDA determines no longer requires a report under section 
510(k) of the FD&C Act (generally referred to as a premarket 
notification or ``510(k)'') to provide reasonable assurance of safety 
and effectiveness. Within 210 days of enactment of the 21st Century 
Cures Act, FDA must publish in the Federal Register a list representing 
its final determination regarding the list of devices proposed in the 
March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that 
upon the date that this final list is published in the Federal 
Register, a 510(k) will no longer be required for the listed devices 
and the applicable classification regulation for these devices shall be 
deemed amended to incorporate such exemption. Interested persons were 
given until May 15, 2017, to comment on the proposed list of class II 
devices. After reviewing these comments and considering whether the 
proposed list should be modified, FDA is now identifying its final 
determination as to which of those devices are now exempt from 
premarket notification requirements, subject to certain limitations, as 
indicated in tables 1 to 3 of this notice.
    In a future action, FDA intends to amend the codified language for 
each listed device's classification regulation to reflect this final 
determination. Persons with pending 510(k) submissions for devices that 
are now exempt from premarket notification, subject to the limitations 
on exemptions, should withdraw their submissions.
    These exemptions will decrease regulatory burdens on the medical 
device industry and will eliminate private costs and expenditures 
required to comply with Federal regulation. Specifically, regulated 
industry will no longer have to invest time and resources in premarket 
notifications, including preparation of documents and data for 
submission to FDA, payment of user fees associated with 510(k) 
submissions, and responding to questions and requests for additional 
information from FDA during 510(k) review.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently 
in the guidance the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k) 
Exemption Guidance'') (Ref. 1).

[[Page 31977]]

III. Limitations on Exemptions

    FDA believes that the types of class II devices listed in this 
notice should be exempt from the premarket notification requirements 
found under section 510(k) of the FD&C Act. However, an exemption from 
the requirement of premarket notification does not mean that the device 
is exempt from any other statutory or regulatory requirements, unless 
such exemption is explicitly provided by order or regulation. FDA's 
determination that premarket notification is unnecessary to provide a 
reasonable assurance of safety and effectiveness for devices listed in 
this document is based, in part, on the assurance of safety and 
effectiveness that other regulatory controls, such as current good 
manufacturing practice requirements, provide.
    In addition to being subject to the general limitations to the 
exemptions found in Title 21 of the Code of Federal Regulations (CFR) 
sections 862.9 to 892.9 (Sec. Sec.  862.9 to 892.9), when Agency 
assessment determines that the factors laid out in the Class II 510(k) 
Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all 
devices in a particular group, FDA may partially limit the exemption 
from premarket notification requirements to specific devices within a 
listed device type. In such situations where a partial exemption 
limitation has been identified, FDA has determined that premarket 
notification is necessary to provide a reasonable assurance of safety 
and effectiveness for these devices. Partial exemption limitations can 
be found in table 2 of this notice. FDA has assigned new product codes 
to the device types that are now exempt subject to the partial 
limitations in order to ensure that these devices can be separated from 
devices that do not fall within the partial exemption limitation under 
the existing product code (i.e., exempt and non-exempt devices within a 
device type will have distinct product codes). If table 2 indicates 
that a partial exemption limitation does apply to a device, then 
affected device manufacturers should review their registration and 
listing information to assess if they should list their device using 
the original classification product code, which requires premarket 
notification, or the new classification product code for the subset of 
that device type that is now 510(k) exempt (subject to the general 
limitations to the exemptions found in Sec. Sec.  862.9 to 892.9). In 
table 2, for example, FDA is listing the exemption of the tympanometer 
but limits the exemption to such devices that are in compliance with 
FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply 
with this partial exemption limitation and the corresponding general 
limitations in Sec.  874.9 are now exempt from the 510(k) requirements 
and should be identified under new product code ``PTP'' in subsequent 
registration and listing submissions. However, tympanometers not in 
compliance with each of these exemption limitations remain subject to 
the 510(k) requirements and will retain product code ``NAS.'' We 
recommend that device manufacturers document in their records any 
changes in the product code of their device with appropriate 
justification.

IV. List of Class II Devices

    In table 1, FDA is identifying the following list of class II 
devices that no longer require premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec. Sec.  862.9 to 892.9:

                        Table 1--Class II Devices
------------------------------------------------------------------------
      21 CFR section               Device type            Product code
------------------------------------------------------------------------
862.1020..................  Acid Phosphatase,          CJN
                             Nitrophenylphosphate.
862.1020..................  Acid Phosphatase, Thymol   CJR
                             Blue Monophosphate.
862.1020..................  Acid Phosphatase,          CJX
                             Disodium Phenylphosphate.
862.1020..................  Acid Phosphatase,          CKB
                             Naphthyl Phosphate.
862.1020..................  Acid Phosphatase,          CKE
                             Thymolphthale
                             Inmonophosphate.
862.1020..................  Acid Phosphatase, Beta     CKH
                             Glycerophosphate.
862.1020..................  Acid Phosphatase           JFH
                             (Prostatic), Tartrate
                             Inhibited.
862.1090..................  Radioassay, Angiotensin    KQN
                             Converting Enzyme.
862.1100..................  Vanillin Pyruvate, AST/    CIF
                             SGOT.
862.1100..................  Diazo, AST/SGOT..........  CIQ
862.1100..................  Hydrazone Colorimetry,     CIS
                             AST/SGOT.
862.1100..................  NADH Oxidation/NAD         CIT
                             Reduction, AST/SGOT.
862.1150..................  Calibrator, Primary......  JIS
862.1150..................  Calibrator, Secondary....  JIT
862.1150..................  Calibrator, Surrogate....  JIW
862.1150..................  Calibrator, Multi-Analyte  JIX
                             Mixture.
862.1345..................  Drink, Glucose Tolerance.  MRV
862.1350..................  Continuous Glucose         PJT
                             Monitor Secondary
                             Display.
862.1445..................  Chromatographic            CEX
                             Separation, Lactate
                             Dehydrogenase Isoenzymes.
862.1445..................  Electrophoretic, Lactate   CFE
                             Dehydrogenase Isoenzymes.
862.1445..................  Differential Rate Kinetic  JGF
                             Method, Lactate
                             Dehydrogenase Isoenzymes.
862.1509..................  System, Test, Urinary      LPT
                             Methylmalonic Acid.
862.1685..................  Radioimmunoassay,          CEE
                             Thyroxine-Binding
                             Globulin.
862.1700..................  Radioimmunoassay, Total    CDX
                             Thyroxine.
862.1700..................  Enzyme Immunoassay, Non-   KLI
                             Radiolabeled, Total
                             Thyroxine.
862.2265..................  High Throughput DNA        PFF
                             Sequence Analyzer.
862.2570..................  Instrumentation For        NSU
                             Clinical Multiplex Test
                             Systems.
862.2570..................  Real Time Nucleic Acid     OOI
                             Amplification System.
862.2570..................  Mass Spectrometer For      OTA
                             Clinical Multiplex Test
                             Systems.
862.2570..................  Micro Total Analysis       OUE
                             Instrument System.
862.2570..................  Complete Gene Expression   OVA
                             Profiling Accessory
                             Reagents.
862.2570..................  DNA Genetic Analyzer.....  PCA
862.2570..................  Data Acquisition Software  PQQ
862.3200..................  Calibrators, Drug Mixture  DKB
862.3200..................  Calibrators, Drug          DLJ
                             Specific.

[[Page 31978]]

 
862.3200..................  Calibrators, Ethyl         DNN
                             Alcohol.
864.5400..................  Fibrometer...............  GIE
864.5400..................  Timer, Coagulation.......  JBT
864.5425..................  Control, Plasma, Abnormal  GGC
864.5425..................  Plasma, Coagulation        GGN
                             Control.
864.5425..................  Plasma, Control, Normal..  GIZ
864.6550..................  Control, Fecal Occult      OSL
                             Blood.
864.6650..................  Study, Platelet Adhesive.  JBZ
864.7275..................  Test, Euglobulin Lysis...  JBO
864.7300..................  Fibrin Monomer             JBN
                             Paracoagulation.
864.7340..................  Fibrinogen Standard......  GFX
864.7340..................  Plasma, Fibrinogen         GIL
                             Control.
864.7375..................  Glutathione, Red-Cell....  GII
864.7375..................  Fluorescence, Visual       JMH
                             Observation (Qual.,
                             U.V.), Glutathione
                             Reductase.
864.7375..................  Assay, Glutathione         KQF
                             Reductase.
864.7415..................  Control, Hemoglobin,       JCM
                             Abnormal.
864.7455..................  Stain, Fetal Hemoglobin..  GHQ
864.7500..................  Acid Hematin.............  GGF
864.7720..................  Test, Prothrombin          GGQ
                             Consumption.
864.7735..................  Prothrombin-Proconvertin   JPF
                             and Thrombotest.
864.8150..................  Calibrator for Cell        KRX
                             Indices.
864.8165..................  Calibrator for Hemoglobin  KRZ
                             and Hematocrit
                             Measurement.
864.8175..................  Calibrator for Platelet    KRY
                             Counting.
864.8185..................  Calibrator for Red-Cell    KSA
                             and White-Cell Counting.
864.8625..................  Standards and Controls,    GFS
                             Hemoglobin, Normal and
                             Abnormal.
864.8625..................  Control, White-Cell......  GGL
864.8625..................  Control, Hemoglobin......  GGM
864.8625..................  Control, Platelet........  GJP
864.8625..................  Control, Red-Cell........  GJR
864.8625..................  Control, Hematocrit......  GLK
864.8625..................  Mixture, Control, White-   GLQ
                             Cell and Red-Cell
                             Indices.
864.8625..................  Control, Cell Counter,     JCN
                             Normal and Abnormal.
864.8625..................  Mixture, Hematology        JPK
                             Quality Control.
864.8625..................  Material, Quality          NRF
                             Control, Semen Analysis.
864.8625..................  Control Material, Blood    NRS
                             Circulating Epithelial
                             Cancer Cell.
864.9400..................  Solution, Stabilized       KSK
                             Enzyme.
866.3395..................  Norovirus Serological      OUC
                             Reagents.
866.5210..................  Immunochemical,            CHN
                             Ceruloplasmin.
866.5210..................  Ceruloplasmin, Rhodamine,  DCT
                             Antigen, Antiserum,
                             Control.
866.5210..................  Ceruloplasmin, FITC,       DCY
                             Antigen, Antiserum,
                             Control.
866.5210..................  Ceruloplasmin, Antigen,    DDB
                             Antiserum, Control.
866.5210..................  P-Phenyl-Enediamine/EDTA   JFQ
                             (Spectrophotometric),
                             Ceruloplasmin.
866.5210..................  Indirect Copper Assay,     JFR
                             Ceruloplasmin.
866.5470..................  Hemoglobin, Chain          DAM
                             Specific, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DDT
                             Rhodamine, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DDY
                             FITC, Antigen,
                             Antiserum, Control.
866.5620..................  Alpha-2-Macroglobulin,     DEB
                             Antigen, Antiserum,
                             Control.
866.5630..................  System, Test, Beta-2-      JZG
                             Microglobulin
                             Immunological.
866.5910..................  Quality Control Material,  NZB
                             Genetics, DNA.
868.1040..................  Algesimeter, Powered.....  BSI
868.1400..................  Legging, Compression, Non- LLK
                             Inflatable.
868.2500..................  Monitor, Oxygen,           KLK
                             Cutaneous, For Infant
                             Not Under Gas Anesthesia.
868.2500..................  Monitor, Oxygen,           LPP
                             Cutaneous, For Uses
                             Other Than For Infant
                             Not Under Gas Anesthesia.
868.2550..................  Pneumotachometer.........  JAX
868.5180..................  Bed, Rocking, Breathing    CCO
                             Assist.
868.6250..................  Compressor, Air, Portable  BTI
870.1390..................  Trocar...................  DRC
870.1875..................  Lung Sound Monitor.......  OCR
870.2675..................  Oscillometer.............  DRZ
870.4280..................  Filter, Prebypass,         KRJ
                             Cardiopulmonary Bypass.
870.4290..................  Adaptor, Stopcock,         DTL
                             Manifold, Fitting,
                             Cardiopulmonary Bypass.
870.4340..................  Monitor and/or Control,    DTW
                             Level Sensing,
                             Cardiopulmonary Bypass.
870.4420..................  Sucker, Cardiotomy         DTS
                             Return, Cardiopulmonary
                             Bypass.
870.4430..................  Suction Control,           DWD
                             Intracardiac,
                             Cardiopulmonary Bypass.
872.1720..................  Tester, Pulp.............  EAT
872.3260..................  External Cleaning          PME
                             Solution.
872.3300..................  Coating, Denture           EBE
                             Hydrophilic, Resin.
872.3540..................  Pad, Denture, Over The     EHR
                             Counter.
872.3540..................  Cushion, Denture, Over     EHS
                             The Counter.
872.3560..................  Reliner, Denture, Over     EBP
                             The Counter.
872.3590..................  Denture, Plastic, Tooth..  ELM

[[Page 31979]]

 
872.3600..................  Denture Preformed          EKO
                             (Partially Prefabricated
                             Denture).
872.3890..................  Splint, Endodontic         ELS
                             Stabilizing.
872.5550..................  Ring, Teething, Fluid-     KKO
                             Filled.
872.6770..................  Syringe, Cartridge.......  EJI
874.1120..................  Generator, Electronic      ETS
                             Noise (for Audiometric
                             Testing).
874.1325..................  Electroglottograph.......  KLX
874.3310..................  Calibrator, Hearing Aid/   ETW
                             Earphone and Analysis
                             Systems.
874.3320..................  Hearing Aid, Group and     EPF
                             Auditory Trainer.
874.3320..................  Device, Assistive          LZI
                             Listening.
874.3330..................  Hearing Aid, Master......  KHL
874.3430..................  Mold, Middle-Ear.........  ETC
874.3730..................  Device, Voice              MCK
                             Amplification.
876.1500..................  Light Source,              FCQ
                             Incandescent, Diagnostic.
876.1500..................  Light Source,              FCR
                             Photographic, Fiberoptic.
876.1500..................  Light Source, Fiberoptic,  FCW
                             Routine.
876.1500..................  Carrier, Sponge,           FGS
                             Endoscopic.
876.1500..................  Light Source, Endoscope,   GCT
                             Xenon Arc.
876.1500..................  Transformer, Endoscope...  GCW
876.1500..................  LED Light Source.........  NTN
876.1500..................  Endoscopic Guide Wire,     OCY
                             Gastroenterology-Urology.
876.4020..................  Light, Catheter,           FCS
                             Fiberoptic, Glass,
                             Ureteral.
876.4270..................  Rod, Colostomy...........  EZP
876.4400..................  Ligator, Hemorrhoidal....  FHN
876.4400..................  Ligator, Esophageal......  MND
876.4500..................  Lithotriptor, Biliary      LQC
                             Mechanical.
876.4770..................  Urethrotome..............  EZO
876.5010..................  Bag, Bile Collecting.....  EXF
876.5025..................  Vibrator for Climax        PIA
                             Control of Premature
                             Ejaculation.
876.5365..................  Dilator, Esophageal        EZM
                             (Metal Olive) Gastro-
                             Urology.
876.5365..................  Bougie, Esophageal, and    FAT
                             Gastrointestinal, Gastro-
                             Urology.
876.5365..................  Dilator, Esophageal......  KNQ
876.5520..................  Dilator, Urethral........  KOE
876.5665..................  Disinfectant, Subsystem,   NIH
                             Water Purification.
876.5820..................  Set, Dialyzer Holder.....  FKI
876.5895..................  Irrigator, Ostomy........  EXD
876.5980..................  Catheter, Retention,       FGD
                             Barium Enema With Bag.
876.5980..................  Gastrostomy Tube Holder..  PLI
878.4370..................  Drape, Surgical, ENT.....  ERY
878.4370..................  Drape, Pure Latex Sheet,   EYX
                             With Self-Retaining
                             Finger Cot.
878.4370..................  Drape, Urological,         EYY
                             Disposable.
878.4370..................  Pad, Kelly...............  FNW
878.4370..................  Drape, Patient,            HMT
                             Ophthalmic.
878.4370..................  Drape, Microscope,         HMW
                             Ophthalmic.
878.4370..................  Ring (Wound Protector),    KGW
                             Drape Retention,
                             Internal.
878.4580..................  Lamp, Operating-Room.....  FQP
878.4580..................  Light, Surgical,           FSQ
                             Instrument.
878.4580..................  Light, Surgical, Floor     FSS
                             Standing.
878.4580..................  Light, Surgical,           FSW
                             Endoscopic.
878.4580..................  Light, Surgical,           FSX
                             Connector.
878.4580..................  Light, Surgical, Ceiling   FSY
                             Mounted.
878.4580..................  Light, Surgical, Carrier.  FSZ
878.4580..................  Light, Surgical,           FTA
                             Accessories.
878.4580..................  Lamp, Surgical...........  FTD
878.4580..................  Illuminator, Remote......  FTG
878.4580..................  Lamp, Surgical,            GBC
                             Incandescent.
878.5070..................  Apparatus, Air Handling,   FZG
                             Bench.
878.5070..................  Apparatus, Air Handling,   FZH
                             Room.
878.5070..................  Apparatus, Air Handling,   FZI
                             Enclosure.
880.5580..................  Locator, Acupuncture       BWJ
                             Point.
880.5580..................  Needle, Acupuncture,       MQX
                             Single Use.
880.5780..................  Stocking, Medical Support  DWL
                             (to Prevent Pooling of
                             Blood in Legs).
882.1020..................  Analyzer, Rigidity.......  GZM
882.1540..................  Device, Galvanic Skin      GZO
                             Response Measurement.
882.1560..................  Device, Skin Potential     HCJ
                             Measurement.
882.1855..................  Encephalogram Telemetry    GYE
                             System.
882.5895..................  Vibratory Counter-         OVP
                             Stimulation.
884.2990..................  Sheet, Recording, Breast   NHM
                             Examination.
884.3200..................  Drain, Cervical..........  HFL
884.4400..................  Forceps, Obstetrical.....  HDA
884.4530..................  Clamp, Umbilical.........  HFW
884.4530..................  Speculum, Vaginal,         HIB
                             Nonmetal.

[[Page 31980]]

 
884.4530..................  Speculum, Vaginal,         HIC
                             Nonmetal, Fiberoptic.
884.4530..................  Clamp and Cutter,          NBZ
                             Umbilical.
884.4900..................  Table, Obstetrical, AC-    HDD
                             Powered (and
                             Accessories).
884.4900..................  Table, Obstetrical,        HHP
                             Manual (and Accessories).
884.4900..................  Table, Obstetric (and      KNC
                             Accessories).
884.5200..................  Hemorrhoid Prevention      OOA
                             Pressure Wedge.
884.5390..................  Heater, Perineal, Direct   HGZ
                             Contact.
884.5390..................  Heater, Perineal,          HHA
                             Radiant, Non-Contact.
884.5390..................  Heater, Perineal.........  KND
884.5400..................  Cup, Menstrual...........  HHE
884.5425..................  Pad, Menstrual, Scented..  HHL
884.6150..................  Micromanipulators and      MQJ
                             Microinjectors, Assisted
                             Reproduction.
886.1120..................  Photorefractor...........  MMF
886.1120..................  Camera, Ophthalmic,        PJZ
                             General-Use.
886.1250..................  Euthyscope, AC-Powered...  HMK
886.1570..................  Ophthalmoscope, AC-        HLI
                             Powered.
886.1570..................  Ophthalmoscope, Battery-   HLJ
                             Powered.
886.1570..................  Ophthalmoscopes,           MSG
                             Replacement Batteries,
                             Hand-Held.
886.1780..................  Retinoscope, AC-Powered..  HKL
886.1945..................  Transilluminator, AC-      HJM
                             Powered.
886.4150..................  Tubing, Replacement,       MSR
                             Phacofragmentation Unit.
886.4250..................  Unit, Electrolysis, AC-    HRO
                             Powered, Ophthalmic.
886.4335..................  Headlight, Fiberoptic      FCT
                             Focusing.
886.4335..................  Light, Headband, Surgical  FSR
886.4335..................  Headlamp, Operating, AC-   HPQ
                             Powered.
886.4400..................  Locator, Metal,            HPM
                             Electronic.
886.4440..................  Magnet, AC-Powered.......  HPO
886.4790..................  Sponge, Ophthalmic.......  HOZ
886.4790..................  Eye Tray.................  OJK
888.1240..................  Dynamometer, AC-Powered..  LBB
888.4580..................  Instrument, Surgical,      JDX
                             Sonic and Accessory/
                             Attachment.
888.4580..................  System, Cement Removal     LZV
                             Extraction.
890.1450..................  Hammer, Reflex, Powered..  IKO
890.5100..................  Bath, Hydro-Massage......  ILJ
890.5100..................  Bath, Sitz, Powered......  ILM
890.5110..................  Bath, Paraffin...........  IMC
890.5250..................  Cabinet, Moist Steam.....  IMB
890.5360..................  Exerciser, Measuring.....  ISD
890.5500..................  Lamp, Infrared,            ILY
                             Therapeutic Heating.
890.5575..................  Device, Warning,           IRN
                             Overload, External Limb,
                             Powered.
892.1000..................  MRI Disposable Kit.......  OIM
892.1560..................  Biopsy Needle Guide Kit..  OIJ
892.1610..................  Aperature, Radiographic..  IZS
892.1610..................  Cone, Radiographic.......  IZT
892.1610..................  Collimator, Automatic,     IZW
                             Radiographic.
892.1610..................  Collimator, Manual,        IZX
                             Radiographic.
892.1610..................  Device, Beam Limiting, X-  KPW
                             Ray, Diagnostic.
892.1650..................  Arthrogram Tray..........  OII
892.1650..................  Radiology Dental Tray....  OIK
892.1670..................  Device, Spot-Film........  IXL
892.1680..................  Radiographic Contrast      OIO
                             Tray.
892.1680..................  Radiology Diagnostic Kit.  OIP
892.1730..................  Discography Kit..........  OIL
892.1820..................  Chair,                     HBK
                             Pneumocephalographic.
892.1850..................  Cassette, Radiographic     IXA
                             Film.
892.1860..................  Changer, Radiographic      KPX
                             Film/Cassette.
892.1870..................  Programmer, Changer, Film/ IZP
                             Cassette, Radiographic.
892.1900..................  Controller, Temperature,   EGT
                             Radiographic.
892.1900..................  Dryer, Film, Radiographic  EGW
892.1900..................  Processor, Radiographic-   EGY
                             Film, Automatic, Dental.
892.1900..................  Processor, Radiographic-   IXW
                             Film, Automatic.
892.1900..................  Processor, Cine Film.....  IXX
892.2030..................  Digitizer, Image,          LMA
                             Radiological.
892.2030..................  Digitizer, Images,         NFH
                             Ophthalmic.
892.2040..................  Camera, Multi Format,      LMC
                             Radiological.
892.2040..................  Device, Hardcopy, Images,  NFI
                             Ophthalmic.
892.5730..................  Prostate Seeding Kit.....  OIN
------------------------------------------------------------------------


[[Page 31981]]

    In table 2, FDA is identifying a list of class II devices that no 
longer require premarket notification under section 510(k) of the FD&C 
Act, subject to the general limitations to the exemptions found in 
Sec. Sec.  862.9 to 892.9, as well as the indicated partial exemption 
limitations. Devices listed in table 2 are now exempt, but only if they 
are in concurrent compliance with both the partial exemption limitation 
specified in table 2 and its corresponding general limitation found in 
the .9 section of Parts 862 to 892 of Title 21 of the CFR.

                                            Table 2--Class II Devices
----------------------------------------------------------------------------------------------------------------
                                                      Exempt product    Former  product      Partial exemption
         21 CFR Section             Device type            code        code (non-exempt)        limitation
----------------------------------------------------------------------------------------------------------------
862.3100.......................  Enzyme             PUX..............  DKZ..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Radioimmunoassay,  PUX..............  DJP..............  Exemption is limited
                                  Amphetamine.                                             to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Thin Layer         PUX..............  DIT..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Gas                PUX..............  DOD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Liquid             PUX..............  DNI..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3100.......................  Free Radical       PUX..............  DJL..............  Exemption is limited
                                  Assay,                                                   to test systems
                                  Amphetamine.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Enzyme             PUY..............  DIS..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31982]]

 
862.3150.......................  Radioimmunoassay,  PUY..............  DKN..............  Exemption is limited
                                  Barbiturate.                                             to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Thin Layer         PUY..............  DKX..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Mercury            PUY..............  DJN..............  Exemption is limited
                                  Dithiazone,                                              to test systems
                                  Colorimetry,                                             intended for
                                  Barbiturate.                                             employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Hemagglutination   PUY..............  DLX..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  Gas Liquid         PUY..............  DMF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Barbiturate.                                             intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3150.......................  High Pressure      PUY..............  KZY..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Barbiturate.                                             employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  Enzyme             PUZ..............  JXM..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Benzodiazepine.                                          intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  High Pressure      PUZ..............  LAA..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Benzodiazepine.                                          employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31983]]

 
862.3170.......................  Test,              PUZ..............  NFV..............  Exemption is limited
                                  Benzodiazepine,                                          to test systems
                                  Over The Counter.                                        intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  Gas                PUZ..............  KZZ..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzodiazepine.                                          intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3170.......................  Thin Layer         PUZ..............  LAB..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzodiazepine.                                          intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Enzyme             PVA..............  DIO..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cocaine and                                              intended for
                                  Cocaine                                                  employment and
                                  Metabolites.                                             insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Radioimmunoassay,  PVA..............  KLN..............  Exemption is limited
                                  Cocaine                                                  to test systems
                                  Metabolite.                                              intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Enzyme             PVA..............  JXO..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cocaine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Hemagglutination,  PVA..............  DLN..............  Exemption is limited
                                  Cocaine                                                  to test systems
                                  Metabolites                                              intended for
                                  (Benzoylecgonine                                         employment and
                                  ).                                                       insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Thin Layer         PVA..............  DMN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Cocaine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31984]]

 
862.3250.......................  Free Radical       PVA..............  DIR..............  Exemption is limited
                                  Assay, Cocaine.                                          to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Gas                PVA..............  DIN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Cocaine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  Thin Layer         PVA..............  DOM..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Benzoylecgonine.                                         intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3250.......................  High Pressure      PVA..............  LAC..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Cocaine and                                              employment and
                                  Cocaine                                                  insurance testing
                                  Metabolites.                                             that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3270.......................  High Pressure      PVB..............  LAE..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Codeine.                                                 employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3270.......................  Thin Layer         PVB..............  DLD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Codeine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3270.......................  Gas                PVB..............  LAD..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Codeine.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3580.......................  Radioimmunoassay,  PVC..............  DLB..............  Exemption is limited
                                  LSD (125-I).                                             to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31985]]

 
862.3580.......................  Free Radical       PVC..............  DOL..............  Exemption is limited
                                  Assay, LSD.                                              to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  Gas                PVD..............  LAF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methamphetamine.                                         intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  Thin Layer         PVD..............  DJC..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methamphetamine.                                         intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  High Pressure      PVD..............  LAG..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Methamphetamine.                                         employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3610.......................  Test,              PVD..............  NGG..............  Exemption is limited
                                  Methamphetamine,                                         to test systems
                                  Over The Counter.                                        intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Enzyme             PVE..............  DJR..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Hemagglutination   PVE..............  DIW..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Gas                PVE..............  DMB..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31986]]

 
862.3620.......................  Thin Layer         PVE..............  DKR..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Liquid             PVE..............  DNT..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Methadone.                                               intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3620.......................  Free Radical       PVE..............  DPP..............  Exemption is limited
                                  Assay, Methadone.                                        to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3630.......................  Radioimmunoassay,  PVF..............  KXS..............  Exemption is limited
                                  Methaqualone.                                            to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Thin Layer         PVG..............  DNK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DOE..............  Exemption is limited
                                  Morphine (123-                                           to test systems
                                  I), Goat                                                 intended for
                                  Antibody                                                 employment and
                                  Ammonium Sulfate                                         insurance testing
                                  Sep..                                                    that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Fluorometry,       PVG..............  DJJ..............  Exemption is limited
                                  Morphine.                                                to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Liquid             PVG..............  DPK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31987]]

 
862.3640.......................  Gas                PVG..............  DMY..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Hemagglutination   PVG..............  DLR..............  Exemption is limited
                                  Inhibition,                                              to test systems
                                  Morphine.                                                intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Free Radical       PVG..............  DOK..............  Exemption is limited
                                  Assay, Morphine.                                         to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DIQ..............  Exemption is limited
                                  Morphine (3-H),                                          to test systems
                                  Goat Antibody                                            intended for
                                  Ammonium Sulfate                                         employment and
                                  Sep..                                                    insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3640.......................  Radioimmunoassay,  PVG..............  DNA..............  Exemption is limited
                                  Morphine-                                                to test systems
                                  Barbiturate (125-                                        intended for
                                  I), Goat                                                 employment and
                                  Antibody.                                                insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Enzyme             PVH..............  DJG..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Opiates.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Gas                PVH..............  DJF..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Opiates.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Hemagglutination,  PVH..............  DLT..............  Exemption is limited
                                  Opiates.                                                 to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31988]]

 
862.3650.......................  Thin Layer         PVH..............  LAI..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Opiates.                                                 intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  Free Radical       PVH..............  DKT..............  Exemption is limited
                                  Assay, Opiates.                                          to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3650.......................  High Pressure      PVH..............  LAH..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Opiates.                                                 employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  Enzyme             PVI..............  JXN..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Propoxyphene.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  Thin Layer         PVI..............  DPN..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Propoxyphene.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  Gas                PVI..............  LAJ..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Propoxyphene.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3700.......................  High Pressure      PVI..............  LAK..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Propoxyphene.                                            employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3870.......................  Enzyme             PVJ..............  LDJ..............  Exemption is limited
                                  Immunoassay,                                             to test systems
                                  Cannabinoids.                                            intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)

[[Page 31989]]

 
862.3870.......................  Reagents, Test,    PVJ..............  DKE..............  Exemption is limited
                                  Tetrahydrocannab                                         to test systems
                                  inol.                                                    intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3870.......................  Radioimmunoassay,  PVJ..............  LAT..............  Exemption is limited
                                  Cannabinoid(S).                                          to test systems
                                                                                           intended for
                                                                                           employment and
                                                                                           insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3910.......................  High Pressure      PVK..............  LFI..............  Exemption is limited
                                  Liquid                                                   to test systems
                                  Chromatography,                                          intended for
                                  Tricyclic                                                employment and
                                  Antidepressant                                           insurance testing
                                  Drugs.                                                   that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3910.......................  U.V.               PVK..............  LFH..............  Exemption is limited
                                  Spectrometry,                                            to test systems
                                  Tricyclic                                                intended for
                                  Antidepressant                                           employment and
                                  Drugs.                                                   insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
862.3910.......................  Thin Layer         PVK..............  MLK..............  Exemption is limited
                                  Chromatography,                                          to test systems
                                  Tricyclic                                                intended for
                                  Antidepressant                                           employment and
                                  Drugs.                                                   insurance testing
                                                                                           that include a
                                                                                           statement in their
                                                                                           labeling that the
                                                                                           device is intended
                                                                                           solely for use in
                                                                                           employment and
                                                                                           insurance testing,
                                                                                           and does not include
                                                                                           test systems intended
                                                                                           for Federal drug
                                                                                           testing programs
                                                                                           (e.g., programs run
                                                                                           by the Substance
                                                                                           Abuse and Mental
                                                                                           Health Services
                                                                                           Administration
                                                                                           (SAMHSA), the
                                                                                           Department of
                                                                                           Transportation (DOT),
                                                                                           and the U.S.
                                                                                           military.)
866.5750.......................  System, Test,      PUW..............  DHB..............  Exemption is limited
                                  Radioallergosorb                                         to devices classified
                                  ent (RAST)                                               under 21 CFR 866.5750
                                  Immunological.                                           that are intended to
                                                                                           detect any of the
                                                                                           allergens included in
                                                                                           table 3 of this
                                                                                           document.
868.2385.......................  Analyzer,          PUG..............  MRQ..............  Exemption is limited
                                  Nitrogen Dioxide.                                        to standalone
                                                                                           nitrogen dioxide
                                                                                           analyzers and not
                                                                                           those that are
                                                                                           components of nitric
                                                                                           oxide delivery
                                                                                           systems intended to
                                                                                           monitor nitrogen
                                                                                           dioxide levels during
                                                                                           inhaled nitric oxide
                                                                                           therapy.
870.1330.......................  Wire, Guide,       PTL..............  DQX..............  Exemption is limited
                                  Catheter.                                                to accessory torque
                                                                                           devices that are
                                                                                           manually operated,
                                                                                           non-patient
                                                                                           contacting, and
                                                                                           intended to
                                                                                           manipulate non-
                                                                                           cerebral vascular
                                                                                           guide wires.
870.1650.......................  Syringe, Balloon   PTM..............  MAV..............  Exemption is limited
                                  Inflation.                                               to non-patient
                                                                                           contacting balloon
                                                                                           inflation syringes
                                                                                           intended only to
                                                                                           inflate/deflate
                                                                                           balloon catheters and
                                                                                           monitor pressure
                                                                                           within the balloon.
870.2770.......................  Analyzer, Body     PUH..............  MNW..............  Exemption is limited
                                  Composition.                                             to body composition
                                                                                           analyzers which are
                                                                                           not intended to
                                                                                           diagnose or treat any
                                                                                           medical condition.
870.4400.......................  Reservoir, Blood,  PTN..............  DTN..............  Exemption is limited
                                  Cardiopulmonary                                          to cardiopulmonary
                                  Bypass.                                                  bypass blood
                                                                                           reservoirs that do
                                                                                           not contain defoamers
                                                                                           or blood filters.
874.1090.......................  Tester, Auditory   PTO..............  ETY..............  Exemption is limited
                                  Impedance.                                               to auditory impedance
                                                                                           testers that are in
                                                                                           compliance with FDA-
                                                                                           recognized consensus
                                                                                           standard ANSI S3.39.
874.1090.......................  Tympanometer.....  PTP..............  NAS..............  Exemption is limited
                                                                                           to tympanometers that
                                                                                           are in compliance
                                                                                           with FDA-recognized
                                                                                           consensus standard
                                                                                           ANSI S3.39.
876.1500.......................  Endoscopic         PTQ..............  FCC..............  Exemption is limited
                                  Magnetic                                                 to endoscopic
                                  Retriever.                                               magnetic retrievers
                                                                                           intended for single
                                                                                           use.
876.1500.......................  Scissors For       PTR..............  KGD..............  Exemption is limited
                                  Cystoscope.                                              to sterile scissors
                                                                                           for cystoscope
                                                                                           intended for single
                                                                                           use.

[[Page 31990]]

 
876.1500.......................  Endoscopic         PTS..............  OCZ..............  Exemption is limited
                                  Grasping/Cutting                                         to disposable, non-
                                  Instrument, Non-                                         powered endoscopic
                                  Powered.                                                 grasping/cutting
                                                                                           instruments intended
                                                                                           for single use.
876.5010.......................  Catheter,          PTT..............  GCA..............  Exemption is limited
                                  Biliary,                                                 to surgical biliary
                                  Surgical.                                                catheters that do not
                                                                                           include a balloon
                                                                                           component.
876.5630.......................  Catheter,          PTU..............  FJS..............  Exemption is limited
                                  Peritoneal, Long-                                        to non-patient
                                  Term Indwelling.                                         contacting catheter
                                                                                           finger grips intended
                                                                                           for single use.
876.5630.......................  Catheter,          PTV..............  FKO..............  Exemption is limited
                                  Peritoneal                                               to non-patient
                                  Dialysis, Single                                         contacting catheter
                                  Use.                                                     finger grips intended
                                                                                           for single use.
876.5630.......................  System,            PTW..............  FKX..............  Exemption is limited
                                  Peritoneal,                                              to continuous
                                  Automatic                                                ambulatory peritoneal
                                  Delivery.                                                dialysis (CAPD) belts
                                                                                           and catheter stands
                                                                                           that do not include
                                                                                           weigh scales.
878.4370.......................  Drape, Surgical..  PUI..............  KKX..............  Exemption is limited
                                                                                           to surgical drapes
                                                                                           that do not include
                                                                                           an antimicrobial
                                                                                           agent.
878.4495.......................  Suture,            PTX..............  GAQ..............  Exemption is limited
                                  Nonabsorbable,                                           to steel monofilament
                                  Steel,                                                   sutures that are
                                  Monofilament And                                         uncoated and do not
                                  Multifilament,                                           incorporate barbs.
                                  Sterile.
882.1470.......................  Computerized       PTY..............  PKQ..............  Exemption is limited
                                  Cognitive                                                to computerized
                                  Assessment Aid.                                          cognitive assessment
                                                                                           aids that are not
                                                                                           intended for
                                                                                           diagnostic assessment
                                                                                           of specific diseases
                                                                                           or conditions and
                                                                                           rely on inputs from
                                                                                           visual cues, auditory
                                                                                           cues, and/or
                                                                                           functional use of the
                                                                                           hand.
884.1630.......................  Colposcope (and    PTZ..............  HEX..............  Exemption is limited
                                  Colpomicroscope).                                        to standard
                                                                                           colposcopes (and
                                                                                           colpomicroscopes)
                                                                                           that use only a white
                                                                                           light source, do not
                                                                                           use filters other
                                                                                           than a green filter,
                                                                                           do not include image
                                                                                           analysis software,
                                                                                           and are not
                                                                                           smartphone-based.
884.4530.......................  Tenaculum,         PUA..............  HDC..............  Exemption is limited
                                  Uterine.                                                 to sterile uterine
                                                                                           tenaculum devices
                                                                                           that do not use
                                                                                           suction and are
                                                                                           intended for single
                                                                                           use.
884.6120.......................  Accessory,         PUB..............  MQG..............  Exemption is limited
                                  Assisted                                                 to simple embryo
                                  Reproduction.                                            incubators with
                                                                                           temperature, gas, and
                                                                                           humidity control
                                                                                           only; syringe pumps;
                                                                                           collection tube
                                                                                           warmers; dish/plate/
                                                                                           microscope stage
                                                                                           warmers; and
                                                                                           controlled-rate
                                                                                           cryopreservation
                                                                                           freezers.
884.6130.......................  Microtools,        PUC..............  MQH..............  Exemption is limited
                                  Assisted                                                 to assisted
                                  Reproduction                                             reproduction
                                  (Pipettes).                                              microtools (pipettes)
                                                                                           manufactured from
                                                                                           glass.
884.6160.......................  Labware, Assisted  PUD..............  MQK..............  Exemption is limited
                                  Reproduction.                                            to dishes and plates
                                                                                           that are intended for
                                                                                           general assisted
                                                                                           reproduction
                                                                                           technology
                                                                                           procedures.
886.1850.......................  Biomicroscope,     PUE..............  HJO..............  Exemption is limited
                                  Slit-Lamp, AC-                                           to slit-lamp, AC-
                                  Powered.                                                 powered
                                                                                           biomicroscopes
                                                                                           intended only for the
                                                                                           visual examination of
                                                                                           the anterior segment
                                                                                           of the eye, are
                                                                                           classified as Group 1
                                                                                           per FDA-recognized
                                                                                           consensus standard
                                                                                           ANSI Z80.36, do not
                                                                                           provide any
                                                                                           quantitative output,
                                                                                           and are not intended
                                                                                           for screening or
                                                                                           automated diagnostic
                                                                                           indications.
886.3320.......................  Ocular Peg.......  PUF..............  MQU..............  Exemption is limited
                                                                                           to ocular pegs
                                                                                           supplied sterile.
----------------------------------------------------------------------------------------------------------------

    In table 2, FDA included devices classified under Sec.  866.5750 
(Radioallergosorbent (RAST) immunological test system). FDA does not 
believe that all devices classified under this regulation meet the 
exemption criteria from premarket notification requirements. The 
devices listed in table 3 are also classified under Sec.  866.5750, but 
this subset no longer requires premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec.  866.9. While the non-exempt devices 
classified under Sec.  866.5750 will retain product code ``DHB'', these 
devices listed in table 3 are reassigned product code ``PUW.''

                        Table 3--Class II Devices
[Sec.   866.5750--Radioallergosorbent (RAST) Immunological Test Systems]
------------------------------------------------------------------------
                                                   Source (taxonomical
     Allergen code          Allergen product              name)
------------------------------------------------------------------------
                              Grass Pollens
------------------------------------------------------------------------
g1....................  Sweet vernal grass.....  Anthoxanthum odoratum.
g3....................  Cocksfoot grass,         Dactylis glomerata.
                         Orchard grass.
g4....................  Meadow fescue..........  Festuca elatior.
g5....................  Rye-grass (perennial     Lolium perenne.
                         rye grass).
g7....................  Common reed (common      Phragmites communis.
                         reed grass).
g8....................  Meadow grass, Kentucky   Poa pratensis.
                         blue (June grass).

[[Page 31991]]

 
g9....................  Redtop, Bentgrass......  Agrostis stolonifera
                                                 Agrostis gigantea
                                                  (Agrostis alba).
g11...................  Brome grass............  Bromus inermis.
g12...................  Cultivated rye           Secale cereale.
                         (cultivated rye grass).
g13...................  Velvet grass...........  Holcus lanatus.
g14...................  Cultivated oat           Avena sativa.
                         (cultivated oat grass).
g15...................  Cultivated wheat         Triticum aestivum
                         (cultivated wheat       (Triticum spp.).
                         grass).
g16...................  Meadow foxtail (meadow   Alopecurus pratensis.
                         foxtail grass).
g17...................  Bahia grass............  Paspalum notatum.
g24...................  Wheat grass, Western...  Agropyron smithii
                                                 (Elymus smithii).
g30...................  Bluegrass, annual......  Poa annua.
g70...................  Wild rye grass.........  Elymus triticoides
                                                 Elymus condensatus.
g71...................  Canary grass...........  Phalaris arundinacea.
g201..................  Barley, cultivated.....  Hordeum vulgare.
g202..................  Maize, corn (cultivated  Zea mays.
                         corn).
g203..................  Salt grass.............  Distichlis spicata.
g204..................  False oat-grass........  Arrhenatherum elatius.
g216..................  Cyn d 1................  Cynodon dactylon.
g701..................  Phl p 1.0102, Phl p      Phleum pratense.
                         5.0101.
g702..................  Phl p 7.0101...........  Phleum pratense.
g703..................  Phl p 12.0101..........  Phleum pratense.
------------------------------------------------------------------------
                              Weed Pollens
------------------------------------------------------------------------
w2....................  Western ragweed........  Ambrosia psilostachya.
w4....................  False ragweed..........  Ambrosia acanthicarpa
                                                 (Franseria
                                                  acanthicarpa).
w5....................  Wormwood...............  Artemisia absinthium
                                                 Artemisia annua.
w6....................  Mugwort................  Artemisia vulgaris.
w7....................  Marguerite, ox-eye       Chrysanthemum
                         daisy.                   leucanthemum.
w8....................  Dandelion..............  Taraxacum vulgare
                                                 Taraxacum officinale.
w9....................  Plantain (English),      Plantago lanceolata.
                         Ribwort.
w10...................  Goosefoot, lamb's        Chenopodium album.
                         quarters.
w11...................  Saltwort (prickly),      Salsola kali
                         Russian thistle.        (Salsola pestifer).
w12...................  Goldenrod..............  Solidago virgaurea
                                                 (Solidago spp.)
w13...................  Cocklebur, common......  Xanthium commune.
w14...................  Common pigweed (rough    Amaranthus retroflexus.
                         pigweed).
w15...................  Scale, Lenscale........  Atriplex lentiformis.
w16...................  Rough marsh elder......  Iva ciliate
                                                 Iva annua.
w17...................  Firebush (Kochia)......  Kochia scoparia.
w18...................  Sheep sorrel...........  Rumex acetosella.
w19...................  Wall pellitory.........  Parietaria officinalis.
w20...................  Nettle (Common stinging  Urtica dioica.
                         nettle).
w21...................  Wall pellitory.........  Parietaria judaica.
w22...................  Japanese hop (careless   Humulus japonicas
                         weed).                  (Humulus scandens).
w23...................  Yellow dock, Yellow      Rumex crispus.
                         dockweed.
w24...................  Spiny pigweed..........  Amaranthus spinosus.
w27...................  Carnation..............  Dianthus spp.
w28...................  Rose...................  Rosa rugosa.
w33...................  Clover.................  Trifolium pratense.
w35...................  Mexican tea............  Chenopodium
                                                  ambrosioides.
w36...................  Rabbit bush............  Ambrosia deltoidea
                                                 (Franseria deltoides).
w37...................  Salt bush, annual......  Atriplex wrightii.
w39...................  Water hemp, Western....  Amaranthus rudis
                                                 (Acnida tamariscina).
w41...................  Burrobrush.............  Hymenoclea salsola.
w42...................  Poverty weed...........
w43...................  Common sagebrush.......  Artemisia tridentata.
w45...................  Alfalfa................  Medicago sativa.
w46...................  Dog fennel.............  Eupatorium
                                                  capillifolium.

[[Page 31992]]

 
w53...................  Geranium...............  Geranium spp.
w67...................  Groundsel bush.........  Baccharis halimifolia.
w69...................  Iodine bush............  Allenrolfea
                                                  occidentalis.
w70...................  Ragweed, slender.......  Ambrosia confertiflora.
w75...................  Wing scale (wingscale).  Atriplex canescens.
w82...................  Careless weed..........  Amaranthus palmeri
                                                 Amaranthus hybridus.
w90...................  Japanese hop...........  Humulus japonicas
                                                 (Humulus scandens).
w203..................  Rape (rape pollen).....  Brassica napus.
w204..................  Sunflower..............  Helianthus annuus.
w206..................  Camomile...............  Matricaria chamomilla.
w207..................  Lupin..................  Lupinus spp.
w210..................  Sugar-beet.............  Beta vulgaris.
w211..................  Par j 2.0101...........  Parietaria judaica.
w231..................  Art v 1................  Artemisia vulgaris
                                                  (Mugwort).
w232..................  Sal k 1................  Salsola kali.
w233..................  Art v 3................  Artemisa vulgaris (LTP,
                                                  Mugwort).
w234..................  Pla l 1................  Plantago lanceolata.
w235..................  Che a 1.0101...........  Chenopodium album.
w236..................  Mer a 1.0101...........  Mercurialis annua.
a753..................  Art v 1................  Artemisia vulgaris
                                                  (Mugwort weed).
------------------------------------------------------------------------
                              Tree Pollens
------------------------------------------------------------------------
t1....................  Box-elder (Maple)......  Acer negundo.
                                                 Acer saccharum.
t2....................  Gray alder, speckled     Alnus incana.
                         alder (alder).
t4....................  Hazel, hazelnut........  Corylus avellana.
                                                 Corylus americana.
t5....................  American beech (beech).  Fagus grandifolia.
                                                 (Fagus americana).
t6....................  Mountain juniper,        Juniperus ashei
                         Mountain cedar.         (Juniperus sabinoides).
t8....................  Elm....................  Ulmus americana.
t9....................  Olive..................  Olea europaea.
t10...................  Walnut.................  Juglans californica
                                                 Juglans nigra.
t11...................  Maple leaf sycamore,     Platanus acerifolia.
                         London plane, Plane
                         tree.
t61...................  Sycamore...............  Platanus occidentalis.
t12...................  Willow.................  Salix caprea
                                                 Salix nigra.
t14...................  Cottonwood (Eastern      Populus deltoides.
                         Cottonwood/Black
                         Cottonwood).
t15...................  White ash..............  Fraxinus americana.
t16...................  White pine.............  Pinus strobus.
t18...................  Eucalyptus, gum-tree...  Eucalyptus globulus.
                                                 (Eucalyptus spp.).
t19/t26...............  Acacia.................  Acacia longifolia
                                                  (Acacia spp.).
t20...................  Mesquite...............  Prosopis glandulosa/
                                                 Prosopis juliflora.
t21...................  Melaleuca, cajeput tree  Melaleuca quinquenervia
                                                  (Melaleuca
                                                  leucadendron).
t22...................  Pecan, hickory.........  Carya illinoinensis
                                                 (Carya pecan).
t23...................  Italian/Mediterranean/   Cupressus sempervirens.
                         funeral cypress.
t24...................  Japanese cypress.......  Chamaecyparis obtusa
                                                  (Chamaecyparis spp.).
t25...................  Ash....................  Fraxinus excelsior.
t27...................  Maple, red.............  Acer rubrum.
t29...................  Acacia.................  Acacia spp.
t30...................  Birch, white...........  Betula populifolia.
t32...................  Willow, black..........  Salix nigra.
t33...................  Ash, Arizona...........  Fraxinus velutina.
t35...................  Cedar, salt............  Tamarix gallica.
t37...................  Bald cypress (white      Taxodium distichum.
                         bald cypress).
t38...................  Elm, Chinese/Siberian..  Ulmus pumila.
t40...................  Hazelnut tree..........  Corylus americana.
t41...................  White hickory..........  Carya alba
                                                 (Carya tomentosa).
t42...................  Oak, red...............  Quercus rubra.
t43...................  Loblolly pine..........  Pinus taeda.
t44...................  Hackberry..............  Celtis occidentalis.

[[Page 31993]]

 
t45...................  Cedar elm..............  Ulmus crassifolia.
t47...................  Juniper, one seed......  Juniperus monosperma.
t48...................  Pine, lodgepole........  Pinus contorta.
t49...................  Pine, ponderosa........  Pinus ponderosa.
t50...................  Beech, European........  Fagus sylvatica.
t51...................  Tree of Heaven.........  Ailanthus altissima.
t52...................  Western white pine.....  Pinus monticola.
t54...................  Russian olive..........  Elaeagnus angustifolia.
t55...................  Scotch broom...........  Cytisus scoparius.
t56...................  Bayberry...............  Myrica cerifera.
t57...................  Red cedar..............  Juniperus virginiana.
t60...................  Western juniper........  Juniperus occidentalis.
t61...................  Sycamore...............  Platanus occidentalis.
t70...................  Mulberry (white          Morus alba.
                         mulberry).
t71...................  Red mulberry...........  Morus rubra.
t72...................  Queen palm.............  Arecastrum
                                                  romanzoffiamon.
t73...................  Australian pine........  Casuarina
                                                  equisetifolia.
t77...................  Oak mix (red, white,     Quercus spp.
                         black).
t80...................  Japanese cypress.......  Chamaecyparis obtusa.
t81...................  Japanese alder.........  Alnus japonica.
t83...................  Mango tree.............  Mangifera indica.
t90...................  Walnut, black..........  Juglans nigra.
t96...................  Poplar, white (poplar).  Populus alba.
t103/.................  Virginia live oak (live  Quercus virginiana.
t218..................   oak).
t105..................  Pepper tree............  Schinus molle.
t110..................  Orange tree............  Citrus sinensis.
t201..................  Spruce, Norway spruce..  Picea abies (Picea
                                                  excelsa).
t202..................  Alder, smooth..........  Alnus incana spp.
                                                  Rugosa
                                                 (Alnus rugosa).
t203..................  Horse chestnut.........  Aesculus hippocastanum.
t205..................  Elder..................  Sambucus nigra.
t206..................  Chestnut...............  Castanea sativa.
t207..................  Douglas fir............  Pseudotsuga menziesii
                                                  (Pseudotsuga
                                                  taxifolia).
t208..................  Linden.................  Tilia cordata.
t209..................  Horn beam..............  Carpinus betulus.
t210..................  Privet.................  Ligustrum vulgare.
t211..................  Sweet gum..............  Liquidambar
                                                  styraciflua.
t212..................  Cedar..................  Libocedrus decurrens.
t213..................  Pine...................  Pinus radiata.
t214..................  Date palm..............  Phoenix canariensis.
t215..................  Lilac..................  Syringa vulgaris.
t217..................  Pepper tree............  Schinus molle.
t217..................  Red alder..............  Alnus rubra.
t218..................  Virginia live oak......  Quercus virginiana.
t218..................  Bayberry (bayberry/      Myrica gale.
                         sweet gale).
t219..................  Palo verde.............  Cercidium floridum.
t219..................  Red cedar..............  Juniperus virginiana.
t220..................  Bet v 4................  Betula verrucosa
                                                  (Birch).
t221..................  Bet v 2.0101, Bet v 4..  Betula verrucosa
                                                  (Birch).
t222..................  Cypress (Arizona         Cupressus arizonica.
                         cypress).
t223..................  Oil palm...............  Elaeis guineensis.
t224..................  Ole e 1................  Olea europaea.
t225..................  Bet v 6................  Betula verrucosa
                                                  (Birch).
t226..................  Cup a 1................  Cupressus arizonica.
t227..................  Ole e 7................  Olea Europaea.
t228..................  Aspen, quaking.........  Populus tremuloides.
t229..................  Eastern hemlock........  Tsuga canadensis.
t230..................  Redwood (sequoia)......  Sequoia sempervirens.
t232..................  Pussy willow...........  Salix discolor.
t240..................  Ole e 9.0101...........  Olea Europaea.
t241..................  Pla a 1.0101...........  Platanus acerifolia.
t242..................  Pla a 2................  Platanus acerifolia.
t243..................  Pla a 3.0101...........  Platanus acerifolia.
t244..................  Cor a 1.0103...........  Corylus avellana.
t245..................  Aln g 1.0101...........  Alnus glutinosa.
t246..................  Cry j 1................  Cryptomeria japonica.
t280..................  Locust tree............  Robinia pseudoacacia.
t401..................  Brazilian peppertree...  Schinus
                                                  terebinthifolius.
t402..................  Mastic tree............  Pistacia lentiscus.

[[Page 31994]]

 
t404..................  Tree of heaven.........  Ailanthus altissima.
t406..................  Date palm..............  Phoenix dactylifera.
a482..................  Ole e 1................  Olea europaea (Olive
                                                  Oil).
------------------------------------------------------------------------
                                  Mites
------------------------------------------------------------------------
d207..................  Blo t 5.0101...........  Blomia tropicalis.
d208..................  Lep d 2.0101...........  Lepidoglyphus
                                                  destructor.
------------------------------------------------------------------------
                      Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1....................  Penicillium chrysogenum  Penicillium chrysogenum
                        (Penicillium notatum)..   (Penicillium notatum).
m2....................  Cladosporium herbarum    Cladosporium herbarum
                         (Hormodendrum).          (Hormodendrum).
m3....................  Aspergillus fumigatus..  Aspergillus fumigatus.
m4....................  Mucor racemosus........  Mucor racemosus.
m5....................  Candida albicans.......  Candida albicans.
m7....................  Botrytis cinerea.......  Botrytis cinerea.
m8....................  Drechslera halodes       Drechslera halodes
                         (Setomelanomma          (Setomelanomma
                         rostrata,                rostrata,
                         Helminthosporium         Helminthosporium
                         halodes,                 halodes).
                         Helminthosporium
                         interseminatum).
m9....................  Fusarium moniliforme     Fusarium moniliforme
                         (Fusarium               (Fusarium
                         proliferatum).           proliferatum).
m10...................  Stemphylium botryosum..  Stemphylium herbarum
                                                 (Stemphylium
                                                  botryosum).
m11...................  Rhizopus nigricans.....  Rhizopus nigricans.
m12...................  Aureobasidium pullulans  Aureobasidium
                                                  pullulans.
m13...................  Phoma betae............  Phoma betae.
m14...................  Epicoccum purpurascens.  Epicoccum purpurascens
                                                 (Epicoccum nigrum).
m15...................  Trichoderma viride.....  Trichoderma viride.
m16...................  Curvularia lunata......  Curvularia lunata
                                                 Curvularia specifera
                                                  (K923044).
m17...................  Cladosporium fulvum....  Cladosporium fulvum.
m18...................  Fusarium culmorum......  Fusarium culmorum.
m19...................  Aspergillus versicolor.  Aspergillus versicolor.
m20...................  Mucor mucedo...........  Mucor mucedo.
m21...................  Aspergillus clavatus...  Aspergillus clavatus.
m22...................  Micropolyspora faeni...  Saccharopolyspora
                                                  rectivirgula
                                                  (Micropolyspora
                                                  faeni).
m23...................  Thermoactinomyces        Thermoactinomyces
                         vulgaris.                vulgaris.
m24...................  Stachybotrys atra......  Stachybotrys chartarum
                                                  (Stachybotrys atra).
m24...................  Paecilomyces spp.......  Paecilomyces spp.
m25...................  Aspergillus versicolor.  Aspergillus versicolor.
m25...................  Penicillium              Penicillium
                         brevicompactum.          brevicompactum.
m26...................  Cladosporium             Cladosporium
                         cladosporioides.         cladosporioides.
m26...................  Penicillium citrinum...  Penicillium citrinum.
m27...................  Penicillium spp........  Penicillium spp.
m29...................  Aspergillus repens.....  Aspergillus repens.
m30...................  Penicillium roqueforti.  Penicillium roqueforti.
m32...................  Cladosporium             Cladosporium
                         cladosporioides.         cladosporioides.
m34...................  Serpula lacrymans......  Serpula lacrymans.
m36...................  Aspergillus terreus....  Aspergillus terreus.
m37...................  Trichophyton             Trichophyton
                         mentagrophytes.          mentagrophytes.
m40...................  Aspergillus amstelodami  Aspergillus
                                                  amstelodami.
m43...................  Saccharomyces carlsberg  Saccharomyces
                                                  carlsbergensis.
m44...................  Saccharomyces            Saccharomyces
                         cerevisiae.              cerevisiae.
m45...................  Hormodendrum hordei....  Hormodendrum hordei.
m46...................  Bipolaris spicifera....  Bipolaris spicifera.
m47...................  Aspergillus nidulans...  Aspergillus nidulans.
m48...................  Aspergillus oryzae.....  Aspergillus oryzae.
m49...................  Fusarium oxysporum.....  Fusarium oxysporum.
m50...................  Micropolyspora faeni...  Saccharopolyspora
                                                  rectivirgula
                                                  (Micropolyspora
                                                  faeni).
m51...................  Thermoactinomyces        Thermoactinomyces
                         vulgaris.                vulgaris.
m53...................  Microspora canis.......  Microsporum canis
                                                 (Microspora canis).
m54...................  Aspergillus flavus.....  Aspergillus flavus.
m63...................  Helminthosporium         Helminthosporium
                         intersemin.              intersemin.
m66...................  Mucor plumbeus.........  Mucor plumbeus.
m67...................  Mycogone...............  Mycogone perniciosa.
m68...................  Nigrospora oryzae......  Nigrospora oryzae.

[[Page 31995]]

 
m69...................  Rhodotorula............  Rhodotorula rubra
                                                 (Rhodotorula
                                                  mucilaginosa).
m70...................  Malassezia furfur        Malassezia furfur
                         (Pityrosporum           (Pityrosporum
                         orbiculare).             orbiculare).
m71...................  Spondylocladium........  Spondylocladium spp.
m72...................  Epidermophyton.........  Epidermophyton
                                                  floccosum.
m73...................  Epicoccum nigrum.......  Epicoccum purpurascens
                                                 (Epicoccum nigrum).
m80...................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin A (Sta a
                         SEA).
m80...................  Helminthosporium spp...  Helminthosporium spp.
m81...................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin B (Sta a
                         SEB).
m88...................  Stemphylium solani.....  Stemphylium solani.
m93...................  Gliocladium fimbriatum.  Gliocladium fimbriatum.
m94...................  Phycomyces               Phycomyces
                         blakesleeanus.           blakesleeanus.
m201..................  Tilletia tritici         Tilletia tritici
                         (Ustilago nuda,         (Ustilago nuda,
                         Ustilago tritici)        Ustilago tritici).
                         (Barley smut).
m202..................  Acremonium kiliense      Acremonium kiliense
                         (Cephalosporium          (Cephalosporium
                         acremonium).             acremonium).
m203..................  Trichosporon pullulans.  Trichosporon pullulans.
m204..................  Ulocladium chartarum...  Ulocladium chartarum.
m205..................  Trichophyton rubrum....  Trichophyton rubrum.
m207..................  Aspergillus niger......  Aspergillus niger.
m208..................  Chaetomium globosum....  Chaetomium globosum.
m209..................  Penicillium frequentans  Penicillium glabrum
                                                 (Penicillium
                                                  frequentans).
m209..................  Stachybotrys chartarum.  Stachybotrys chartarum
                                                  (Stachybotrys atra).
m210..................  Trichophyton             Trichophyton
                         mentagrophytes var.      mentagrophytes var.
                         goetzii.                 goetzii.
m211..................  Trichophyton             Trichophyton
                         mentagrophytes var.      mentagrophytes var.
                         interdigitale.           interdigitale.
m211..................  Oat smut...............  Ustilago avenae.
m212..................  Micropolyspora faeni...  Saccharopolyspora
                                                  rectivirgula
                                                  (Micropolyspora
                                                  faeni).
m212..................  Geotrichum candidum....  Geotrichum candidum.
m213..................  Bermuda grass smut.....  Ustilago cynodontis.
m214..................  Johnson grass smut.....  Sphacelotheca cruenta.
m215..................  Corn smut..............  Ustilago maydis.
m218..................  Asp f 1.0101...........  Aspergillus fumigatus.
a3050.................  Asp r 1................  Aspergillus restrictus.
m219..................  Asp f 2................  Aspergillus fumigatus.
m220..................  Asp f 3.0101...........  Aspergillus fumigatus.
m221..................  Asp f 4................  Aspergillus fumigatus.
m222..................  Asp f 6.0101...........  Aspergillus fumigatus.
m223..................  Staphylococal            Staphylococus aureus.
                         enterotoxin C (Sta a
                         SEC).
m224..................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin D (Sta a
                         SED).
m226..................  Staphylococcal           Staphylococcus aureus.
                         enterotoxin TSST (Sta
                         a TSST).
m227..................  Malassezia spp.          Malassezia spp.
                         (Pityrosporum spp.).     (Pityrosporum spp.).
m228..................  Aspergillus flavus.....
m229..................  Alt a 1.0101...........  Alternaria alternata
                                                  (Alternaria tenuis).
m230..................  Alt a 6.0101...........  Alternaria alternata
                                                  (Alternaria tenuis).
m231..................  Cla h 8.0101...........  Cladosporium herbarum
                                                  (Hormodendrum).
m300..................  Eurotium spp...........  Eurotium spp.
m304..................  Aspergillus oryzae.....  Aspergillus oryzae.
m305..................  Penicillium              Penicillium
                         brevicompactum.          brevicompactum.
m309..................  Aspergillus terreus....  Aspergillus terreus.
m310..................  Aspergillus nidulans...  Aspergillus nidulans.
m311..................  Aspergillus flavus.....  Aspergillus flavus.
m312..................  Aspergillus clavatus...  Aspergillus clavatus.
------------------------------------------------------------------------
                           Epidermal & Animal
------------------------------------------------------------------------
e6....................  Guinea pig epithelium..  Cavia porcellus.
e7....................  Pigeon droppings.......  Columba palumbus
                                                 Columba livia.
e25...................  Chicken serum..........  Gallus domesticus
                                                 (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e26...................  Parrot serum...........  Psittacoidea spp.
e62...................  Camel..................  Camelus dromedaries.
e70...................  Goose feathers.........  Anser anser.
e71...................  Mouse epithelium.......  Mus musculus
                                                 (Mus spp.).
e73...................  Rat epithelium.........  Rattus norvegicus.
e74...................  Rat urine proteins.....  Rattus norvegicus
                                                 Rattus rattus.

[[Page 31996]]

 
e75...................  Rat serum proteins.....  Rattus norvegicus
                                                 Rattus rattus.
e76...................  Mouse serum proteins...  Mus musculus
                                                 (Mus spp.).
e77...................  Budgerigar droppings...  Melopsittacus
                                                  undulatus.
e78...................  Budgerigar feathers....  Melopsittacus
                                                  undulatus.
e79...................  Budgerigar serum         Melopsittacus
                         proteins.                undulatus.
e80...................  Goat epithelium........  Capra hircus.
e81...................  Sheep epithelium.......  Ovis aries
                                                 (Ovis spp.).
e82...................  Rabbit epithelium......  Oryctolagus cuniculus
                                                 (Oryctolagus spp.).
e83...................  Swine epithelium.......  Sus scrofa
                                                 (Sus scrofa domesticus;
                                                  Sus spp.).
e84...................  Hamster epithelium.....  Cricetus cricetus,
                                                  Mesocricetus auratus,
                                                  and Phodopus sungorus.
e85...................  Chicken feathers.......  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e86...................  Duck feathers..........  Anas platyrhynchos.
e87...................  Rat epithelium, serum    Rattus norvegicus
                         proteins, and urine     Rattus rattus.
                         proteins.
e88...................  Mouse epithelium, serum  Mus musculus (Mus
                         proteins, and urine      spp.).
                         proteins (mouse).
e89...................  Turkey feathers........  Meleagris gallopavo.
e90...................  Budgerigar serum         Melopsittacus
                         proteins, feathers,      undulatus.
                         and droppings.
e91...................  Pigeon serum proteins,   Streptopelia
                         feathers, and            roseogrisea
                         droppings.              Psittacidae spp.
e92...................  Parrot serum proteins,   Ara spp.
                         feathers, and
                         droppings.
e93...................  Pigeon serum proteins..  Streptopelia
                                                  roseogrisea.
e94...................  Fel d 1.0101...........  Felis domesticus.
a345..................  Fel d 1................  Felis domesticus.
e98...................  Parrot droppings.......  Psittacoidea spp.
e101..................  Can f 1.0101...........  Canis familiaris (Canis
                                                  domesticus).
a174..................  Can f 1................  Canis familiaris (Canis
                                                  domesticus).
e102..................  Can f 2.0101...........  Canis familiaris (Canis
                                                  domesticus).
e196..................  Parakeet feathers......  Nymphicus hollandicus.
e197..................  Parakeet droppings.....  Nymphicus hollandicus.
e198..................  Parakeet serum.........  Nymphicus hollandicus.
e199..................  Canary bird serum......  Serinus canarius.
e200..................  Canary bird droppings..  Serinus canarius.
e201..................  Canary bird feathers     Serinus canarius.
                         (Canary feathers).
e202..................  Reindeer epithelium....  Rangifer tarandus.
e203..................  Mink epithelium........  Mustela spp.
e204..................  Bos d 6................  Bos domesticus (Bos
                                                  taurus; Bos spp.).
e205..................  Horse, serum proteins..  Equus caballus (Equus
                                                  spp.).
e206..................  Rabbit, serum proteins.  Oryctolagus cuniculus
                                                  (Oryctolagus spp.).
e208..................  Chinchilla epithelium..  Chinchilla laniger.
e209..................  Gerbil epithelium......  Meriones unguiculatus.
e210..................  Fox epithelium.........  Vulpes vulpes.
e211..................  Rabbit, urine proteins.  Oryctolagus cuniculus
                                                 (Oryctolagus spp.).
e212..................  Swine, urine proteins..  Sus scrofa
                                                 (Sus scrofa domesticus;
                                                  Sus spp.).
e213..................  Parrot feathers........  Ara spp.
e214..................  Finch feathers.........  Lonchura domestica.
e215..................  Pigeon feathers........  Streptopelia
                                                  roseogrisea
                                                 (Streptopelia spp.)
                                                 Columbia spp.
e216..................  Deer epithelium........  Dama dama.
e217..................  Ferret epithelium......  Mustela putorius.
e218..................  Chicken droppings......  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e219..................  Chicken, serum proteins  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
e220..................  Fel d 2, Cat serum       Felis domesticus.
                         albumin.
e221..................  Can f 3................  Canis familiaris (Canis
                                                  domesticus)
                                                 (Dog serum albumin).
e222..................  Swine serum albumin      Sus scrofa (Sus scrofa
                         (Sus s PSA).             domesticus; Sus spp.).
e225..................  Lovebird feathers......  Psittacoidea agapomis.
e226..................  Can f 5.0101...........  Canis familiaris.
e227..................  Equ c 1.0101...........  Equus caballus.
e228..................  Fel d 4.0101...........  Felis domesticus.
e230..................  Equ c 3................  Equus caballus.

[[Page 31997]]

 
e231..................  Mus m 1................  Mus musculus.
------------------------------------------------------------------------
                                  Food
------------------------------------------------------------------------
f9....................  Rice...................  Oryza sativa.
f12...................  Pea (green pea)........  Pisum sativum.
f15...................  White bean.............  Phaseolus vulgaris.
f19...................  Cayenne pepper.........  Capsicum frutescens
                                                 (Capsicum annum).
f21...................  Sugar cane.............  Saccharum officinarum.
f22...................  Raspberry..............  Rubus idaeus.
f26...................  Pork...................  Sus scrofa (Sus scrofa
                                                  domesticus; Sus spp.).
f29...................  Watermelon.............  Citrullus lanatus
                                                 (Citrullus vulgaris).
f31...................  Carrot.................  Daucus carota.
f32...................  Oyster mushroom........  Pleurotus ostreatus.
f33...................  Orange.................  Citrus sinensis.
f35...................  Potato.................  Solanum tuberosum.
f43...................  Mother's milk..........  Homo sapiens.
f44...................  Strawberry.............  Fragaria vesca
                                                  (Fragaria spp.).
f45...................  Yeast, baker's.........  Saccharomyces
                                                  cerevisiae.
f46...................  Pepper, Red............  Capsicum annuum.
f47...................  Garlic.................  Allium sativum.
f48...................  Onion..................  Allium cepa.
f49...................  Apple..................  Malus x domestica
                                                 (Malus spp.).
f51...................  Bamboo shoot...........  Phyllostachys
                                                  pubescens.
f52...................  Cacao/chocolate........  Theobroma cacao.
f54...................  Sweet potato...........  Ipomoea batatas.
f55...................  Common millet..........  Panicum miliaceum.
f56...................  Foxtail millet.........  Setaria italica.
f57...................  Japanese millet........  Echinochloa crus-galli.
f58...................  Pacific squid..........  Todarodes pacificus.
f59...................  Octopus................  Octopus vulgaris
                                                  (Octopus spp.).
f63...................  Kefir..................  NA.
f67...................  Parmesan cheese........  NA.
f81...................  Cheese, cheddar type...  NA.
f82...................  Cheese, mold type......  NA.
f83...................  Chicken................  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
f86...................  Parsley................  Petroselinum crispum.
f87...................  Melon..................  Cucumis melo Cucumis
                                                  melo + Citrullus
                                                  lanatus.
f88...................  Mutton (lamb)..........  Ovis aries (Ovis spp.).
f90...................  Malt...................  Hordeum vulgare.
f92...................  Banana.................  Musa spp.
f93...................  Cacao..................  Theobroma cacao.
f94...................  Pear...................  Pyrus communis (Pyrus
                                                  spp.).
f97...................  Yam....................  Dioscorea spp.
                                                 Dioscorea opposita.
f97...................  Chamomile tea..........  Matricaria chamomilla.
f98...................  Gliadin................  Triticum aestivum
                                                  (Triticum spp.).
f102..................  Cantaloupe.............  Cucumis melo var.
                                                  cantalupensis.
f105..................  Chocolate..............  Theobroma cacao.
f109..................  Cottonseed.............  Gossypium hirsutum.
f110..................  Giant radish...........  Raphanus sativus.
f118..................  Zucchini...............  Cucurbita pepo.
f119..................  Radish.................  Raphanus sativus.
f120..................  Venison................  Capreolus capeolus.
f121..................  Pinto bean.............  Phaseolus vulgaris.
f122..................  Cheese, American.......  NA.
f127..................  Black-eyed pea.........  Vigna unguiculata.
f131..................  Black Olive............  Olea europaea.
f136..................  Red beet...............  Beta vulgaris var.
                                                  conditiva.
f139..................  Goat's Cheese..........  Capra aegagrus.
f140..................  Bran...................  NA.
f141..................  Corn (vegetables)......  Zea mays.
f152..................  Green bell pepper......  Capsicum annuum.
f155..................  Brewer's yeast.........  Saccharomyces
                                                  carlsbergensis.
f157..................  Duck...................  Anas domesticus.
f158..................  Goose..................  Anser anser.
f160..................  Camembert cheese.......  NA.

[[Page 31998]]

 
f162..................  Nectarine..............  Prunus persica var.
                                                  nucipersica.
f163..................  Kohlrabi...............  Brassica oleracea var.
                                                  gongylodes.
f65...................  Perch..................
f166..................  Leek...................  Allium porrum.
f170..................  Cheese (Switzerland)     NA.
                         (Swiss cheese).
f174..................  Fig....................  Ficus carica.
f177..................  Cranberry..............  Vaccinium macrocarpon.
f179..................  Raisin.................  Vitis spp.
f182..................  Lima bean..............  Phaseolus lunatus.
f198..................  Flaxseed (bruised        Linum usitatissimum.
                         grain).
f199..................  Untreated native milk..  Bos domesticus (Bos
                                                  taurus; Bos spp.).
f208..................  Lemon..................  Citrus limon.
f209..................  Grapefruit.............  Citrus paradisi.
f210..................  Pineapple..............  Ananas comosus.
f211..................  Blackberry.............  Rubus fruticosus.
f212..................  Mushroom (champignon)..  Agaricus hortensis
                                                 (Agaricus spp.).
f213..................  Rabbit.................  Oryctolagus cuniculus
                                                 (Oryctolagus spp.).
f214..................  Spinach................  Spinacia oleracea.
f215..................  Lettuce................  Lactuca sativa.
f216..................  Cabbage................  Brassica oleracea var.
                                                  capitata.
f217..................  Brussels sprouts.......  Brassica oleracea var.
                                                  gem.
f218..................  Paprika, sweet pepper..  Capsicum annuum.
f219..................  Fennel seed............  Foeniculum vulgare.
f219..................  Sage...................  Salvia officinalis.
f220..................  Cinnamon...............  Cinnamomum spp.
f221..................  Coffee.................  Coffea spp.
f222..................  Tea....................  Camellia sinensis.
f223..................  Green olive............  Olea europaea.
f225..................  Summer squash, pumpkin.  Cucurbita pepo.
f225..................  Pumpkin................  Cucurbita maxima.
f226..................  Pumpkin seed...........  Cucurbita pepo.
f227..................  Sugar-beet seed........  Beta vulgaris.
f229..................  Safflower Seed.........  Carthamus tinctorius.
f231..................  Milk, boiled...........  Bos domesticus
                                                 (Bos taurus; Bos spp.).
f234..................  Vanilla................  Vanilla planifolia.
f237..................  Apricot................  Prunus armeniaca.
f241..................  Gouda cheese...........  NA.
f242..................  Cherry.................  Prunus avium.
f244..................  Cucumber...............  Cucumis sativus.
f246..................  Guar, guar gum.........  Cyamopsis
                                                  tetragonoloba.
f247..................  Honey..................  NA.
f248..................  Rosemary...............  Rosmarinus officinalis.
f254..................  Plaice.................  Pleuronectes platessa.
f255..................  Plum...................  Prunus domestica
                                                 Prunus americana.
f258..................  Squid..................  Loligo spp.
f259..................  Grape..................  Vitis vinifera
                                                 (Vitis spp.).
f260..................  Broccoli...............  Brassica oleracea var.
                                                  italica (Brassica
                                                  oleracea var.
                                                  cultivar).
f261..................  Asparagus..............  Asparagus officinalis.
f262..................  Aubergine, eggplant....  Solanum melongena.
f263..................  Green pepper...........  Piper nigrum
                                                 Capsicum annuum.
f264..................  Eel....................  Anguilla anguilla.
f265..................  Caraway................  Carum carvi.
f265..................  Cumin..................  Cuminum cyminum.
f266..................  Mace...................  Myristica fragrans.
f267..................  Cardamon...............  Elettaria cardamomum.
f268..................  Clove..................  Syzygium aromaticum.
f269..................  Basil..................  Ocimum basilicum.
f270..................  Ginger.................  Zingiber officinale.
f271..................  Anise..................  Pimpinella anisum.
f272..................  Tarragon...............  Artemisia dracunculus.
f273..................  Thyme..................  Thymus vulgaris.
f274..................  Marjoram...............  Origanum majorana.
f275..................  Lovage.................  Levisticum officinale.
f276..................  Fennel, fresh..........  Foeniculum vulgare.

[[Page 31999]]

 
f277..................  Dill...................  Anethum graveolens.
f278..................  Bay leaf...............  Laurus nobilis.
f279..................  Chili pepper...........  Capsicum frutescens.
f280..................  Black pepper...........  Piper nigrum.
f281..................  Curry (Santa Maria)....  NA.
f282..................  Nutmeg.................  Myristica fragrans.
f283..................  Oregano................  Origanum vulgare.
f284..................  Turkey meat............  Meleagris gallopavo.
f285..................  Elk/moose meat.........  Alces spp.
f286..................  Mare's milk............  Equus caballus (Equus
                                                  spp.).
f287..................  Red kidney bean........  Phaseolus vulgaris.
f288..................  Blueberry..............  Vaccinium myrtillus
                                                  (Vaccinium spp.).
f289..................  Date...................  Phoenix dactylifera.
f291..................  Cauliflower............  Brassica oleracea var.
                                                  botrytis.
f292..................  Guava..................  Psidium guajava.
f293..................  Papaya.................  Carica papaya.
f294..................  Passion fruit, Maracuja  Passiflora edulis
                                                  (Passiflora spp.).
f295..................  Carambola..............  Averrhoa carambola.
f296..................  Carob..................  Ceratonia siliqua.
f297..................  Gum arabic.............  Acacia senegal (Acacia
                                                  spp.).
f298..................  Tragacanth.............  Astragalus spp.
f299..................  Sweet chestnut           Castanea sativa.
                         (chestnut).
f300..................  Pinto bean.............  Phaseolus spp.
f301..................  Persimmon (kaki fruit,   Diospyros kaki.
                         sharon).
f302..................  Mandarin (tangerine,     Citrus reticulata.
                         clementine, satsumas).
f305..................  Fenugreek..............  Trigonella foenum-
                                                  graecum.
f306..................  Lime...................  Citrus aurantifolia.
f307..................  Hake...................  Merluccius merluccius.
f308..................  Sardine (pilchard).....  Sardina pilchardus.
f310..................  Blue vetch.............  Lathyrus sativus.
f311..................  Megrim.................  Lepidorhombus
                                                  whiffiagonis.
f315..................  Green bean.............  Phaseolus vulgaris.
f316..................  Rape seed..............  Brassica napus.
f317..................  Coriander..............  Coriandrum sativum.
f318..................  Jack fruit.............  Artocarpus
                                                  heterophyllus.
f319..................  Beetroot...............  Beta vulgaris.
f320..................  Crayfish...............  Astacus astacus.
f321..................  Horse meat.............  Equus caballus (Equus
                                                  spp.).
f322..................  Red currant............  Ribes sylvestre.
f324..................  Hop (fruit cone).......  Humulus lupulus.
f325..................  Saffron................  Colchicum autumnale.
f328..................  Fig....................  Ficus carica.
f329..................  Watermelon.............  Citrullus lanatus.
f330..................  Rose hip...............  Rosa spp.
f331..................  Saffron................  Crocus sativus.
f332..................  Mint...................  Mentha piperita.
f333..................  Linseed................  Linum usitatissimum.
f336..................  Jujube.................  Ziziphus jujuba.
f336..................  Wine vinegar...........  Vitis vinifera (Vitis
                                                  spp.).
f337..................  Sole...................  Solea solea.
f337..................  English sole...........  Parophrys vetulus.
f338..................  Wine, white............  Vitis vinifera (Vitis
                                                  spp.).
f339..................  Allspice...............  Pimenta dioica.
f339..................  Wine, red..............  Vitis vinifera (Vitis
                                                  spp.).
f341..................  Cranberry..............  Vaccinium oxycoccus
                                                 Vaccinium macrocarpon.
f342..................  Olive (black, fresh)...  Olea europaea.
f343..................  Raspberry..............  Rubus idaeus.
f344..................  Sage...................  Salvia officinalis.
f346..................  Chives.................  Allium schoenoprasum.
f347..................  Quinoa.................  Chenopodium quinoa.
f348..................  Litchi.................  Litchi chinensis.
f349..................  Chum salmon roe........  Oncorhynchus keta.
f358..................  Artichoke..............  Cynara scolymus.
f360..................  Yogurt.................  NA.
f368..................  Black bass.............  Micropterus dolomieu
                                                  (Micropterus
                                                  dolomieui).
f374..................  Karaya gum.............  Sterculia urens.
f375..................  Horseradish............  Armoracia rusticana.
f377..................  Maple syrup............  NA.
f379..................  Okra...................  Abelmoschus esculentus.

[[Page 32000]]

 
f382..................  Beet, sugar............  Beta vulgaris var.
                                                  altissima.
f401..................  Loquat.................  Eriobotrya japonica.
f402..................  Fig....................  Ficus carica.
f403..................  Brewer's yeast.........  Saccharomyces
                                                  cerevisiae.
f405..................  Mint...................  Mentha spp.
f406..................  Arugula................  Eruca vesicaria.
------------------------------------------------------------------------
                               House Dust
------------------------------------------------------------------------
h1....................  Greer Labs., Inc.......  NA.
h2....................  Hollister-Stier Labs...  NA.
h6....................  Japan..................  NA.
------------------------------------------------------------------------
                            Venoms & Insects
------------------------------------------------------------------------
i7....................  Midge..................  Chironomus yoshimatsui.
i8....................  Moth...................  Bombyx mori
                                                 Heterocera spp.
i47...................  Water flea.............  Daphnia spp.
i49...................  Deer fly...............  Chrysops spp.
i51...................  Black ant..............  Camponotus
                                                  pennsylvanicus.
i54...................  Flea mix (dog/cat),      Ctenocephalides spp.
                         common flea.
i71...................  Mosquito...............  Aedes communis
                                                 Aedes spp. and Culex
                                                  spp.
i72...................  Green nimitti..........  Cladotanytarsus lewisi.
i73...................  Blood worm.............  Chironomus thummi
                                                 Chironomusri parius
                                                 Chironomus spp.
i75...................  European hornet........  Vespa crabro.
i76...................  Berlin beetle..........  Trogoderma angustum.
i77...................  European paper wasp....  Polistes dominulus.
i78...................  Fly....................  Musca domestica.
i80...................  Bumblebee..............  Bombus pennsylvanicus.
i201..................  Horse bot fly..........  Gasterophilus
                                                  intestinalis.
i202..................  Grain weevil...........  Sitophilus granarius.
i203..................  Mediterranean flour      Ephestia kuehniella
                         moth.                    (Anagasta kuehniella).
i204..................  Horse fly..............  Tabanus spp.
i205..................  Bumblebee..............  Bombus terrestris.
i208..................  Api m 1.0101...........  Apis mellifera.
a45...................  Api m 1................  Apis mellifera.
i209..................  Ves v 5.0101...........  Vespula vulgaris.
a670..................  Ves v 5................  Vespula vulgaris.
i210..................  Pol d 5.0101...........  Polistes dominulus.
i211..................  Ves v 1.0101...........  Vespula vulgaris.
i213..................  Api m 4................  Apis mellifera.
i214..................  Api m 2................  Apis mellifera.
i215..................  Api m 3................  Apis mellifera.
i216..................  Api m 5................  Apis mellifera.
i217..................  Api m 10...............  Apis mellifera.
i220..................  Bla g 1.0101...........  Blattella germanica.
i221..................  Bla g 2.0101...........  Blattella germanica.
i222..................  Bla g 5.0101...........  Blattella germanica.
i223..................  Bla g 7................  Blattella germanica
a46...................  Api m 2................  Apis mellifera.
------------------------------------------------------------------------
                              Miscellaneous
------------------------------------------------------------------------
o1....................  Cotton, crude fibers...  Gossypium spp.
o3....................  Cotton (treated).......  Gossypium spp.
o70...................  Seminal fluid..........  Homo sapiens.
o71...................  Staphylococcus aureus..  Staphylococcus aureus.
o72...................  Pichia pastoris crude    Pichia pastoris.
                         extract customer
                         specific.
o72...................  Sperm-sediment.........  Homo sapiens.
o73...................  Pichia pastoris crude    Pichia pastoris.
                         extr. vector customer
                         specific.
o74...................  Pichia pastoris with     Pichia pastoris.
                         vector customer
                         specific.
o201..................  Tobacco leaf, tobacco    Nicotiana tabacum.
                         dust.
o202..................  Artemia salina, fish     Artemia salina.
                         feed.
o203..................  Tetramin, fish feed....  NA.
o207..................  Daphnia, fish feed.....  Daphnia spp.
o211..................  Mealworm...............  Tenebrio molitor.

[[Page 32001]]

 
o212..................  Streptavidin...........  Streptomyces avidini.
o213..................  MBP (maltose binding     Escherichia coli.
                         protein).
o214..................  CCD; MUXF3 from          Ananas comosus.
                         bromelain.
o72...................  Enterotoxin A (Sta a     Staphylococcus aureus.
                         SEA).
o73...................  Enterotoxin B (Sta a     Staphylococcus aureus.
                         SEB).
------------------------------------------------------------------------
                                Parasites
------------------------------------------------------------------------
p1....................  Ascaris................  Ascaris suum.
p2....................  Echinococcus...........  Echinococcus
                                                  granulosus.
p3....................  Schistosoma............  Schistosoma mansoni.
p4....................  Anisakis (Herring Worm)  Anisakis simplex
                                                  (Anisakis spp.).
p5....................  Toxocara canis.........  Toxocara canis.
p10...................  Ani s 3.0101...........  Anisakis simplex
                                                  (Anisakis spp.).
p11...................  Ani s 1................  Anisakis simplex
                                                  (Anisakis spp.).
------------------------------------------------------------------------
                              Occupational
------------------------------------------------------------------------
k4....................  Threshing dust.........  NA.
k5....................  Flax...................  NA.
k7....................  Hay Dust...............  NA.
k8....................  Hop (hops).............  Humulus lupulus.
k12...................  Grain mill dust........  NA.
k14...................  Kapok..................  NA.
k20...................  Sheep's wool (treated)   Ovis aries (Ovis spp.).
                         (wool).
k21...................  Sheep's wool             Ovis aries (Ovis spp.).
                         (Untreated).
k23...................  Straw Dust.............  NA.
k33...................  Oak....................  NA.
k70...................  Green coffee bean......  Coffea spp.
k71...................  Castor bean............  Ricinus communis.
k72...................  Ispaghula..............  Plantago psyllium/
                                                  Plantago ovata.
k73...................  Silk waste.............  NA.
k74...................  Silk...................  Bombyx mori.
k75...................  Isocyanate TDI (Toluene  NA.
                         diisocyanate).
k76...................  Isocyanate MDI           NA.
                         (Diphenylmethane
                         diisocyanate).
k77...................  Isocyanate HDI           NA.
                         (Hexamethylen
                         diisocyanate).
k78...................  Ethylene oxide.........  NA.
k79...................  Phthalic anhydride.....  NA.
k80...................  Formaldehyde/Formalin..  NA.
k81...................  Ficus..................  Ficus benjamina (Ficus
                                                  spp.).
k83...................  Cotton seed............  Gossypium hirsutum.
k84...................  Sunflower seed.........  Helianthus annuus.
k85...................  Chloramin T............  NA.
k86...................  Trimellitic anhydride,   NA.
                         TMA.
k87...................  Asp o 21, alpha-amylase  Aspergillus oryzae.
k89...................  Orris root.............  Iris florentina.
k99...................  HSA (Human Serum         Homo sapiens.
                         Albumin) (Hom s HSA).
k201..................  Car p 1, Papain........  Carica papaya.
k202..................  Ana c 2, Bromelain.....  Ananas comosus.
k204..................  Maxatase...............  Bacillus licheniformis.
k205..................  Alcalase...............  Bacillus spp.
k206..................  Savinase, Protease 1     Bacillus spp.
                         (Bac l Subtilisin).
k208..................  Gal d 4, Lysozyme......  Gallus domesticus
                                                  (Gallus gallus
                                                  domesticus; Gallus
                                                  spp.).
k209..................  Hexahydrophtalic         NA.
                         anhydrid.
k210..................  Maleic anhydride.......  NA.
k211..................  Methyltetrahydrophtalic  NA.
                         anhydrid.
k212..................  Abachi wood dust.......  Triplochiton
                                                  scleroxylon.
k213..................  Pepsin (Sus s Pepsin)..  Sus scrofa (Sus scrofa
                                                  domesticus; Sus spp.).
k213..................  TCPA...................  NA.
k214..................  Bougainvillea..........  Bougainvillea spp.
k225..................  Horse radish peroxidase  Armoracia rusticana.
                         (Arm r HRP).
k226..................  Ascorbate oxidase (Cuc   Cucurbita pepo.
                         p ascorbate oxidase).
k301..................  Flour dust.............  Triticum spp.
k501..................  Savinase customer        Proprietary knowledge
                         specific.                of customer.
k502..................  Lipolase customer        Proprietary knowledge
                         specific.                of customer.
k503..................  Termamyl customer        Proprietary knowledge
                         specific.                of customer.
k504..................  Clazinase customer       Proprietary knowledge
                         specific.                of customer.
------------------------------------------------------------------------


[[Page 32002]]

V. Reference

    The following reference is on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, ``Procedures for Class II Device Exemptions From 
Premarket Notification, Guidance for Industry and CDRH Staff,'' 
February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

    Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14453 Filed 7-10-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                  31976                           Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                  human tests to begin became effective                    DEPARTMENT OF HEALTH AND                              the FD&C Act (generally referred to as
                                                  on March 10, 1997. However, FDA                          HUMAN SERVICES                                        a premarket notification or ‘‘510(k)’’) to
                                                  records indicate that the IDE was                                                                              provide reasonable assurance of safety
                                                  determined substantially complete for                    Food and Drug Administration                          and effectiveness. Within 210 days of
                                                  clinical studies to have begun on March                  [Docket No. FDA–2017–N–1129]                          enactment of the 21st Century Cures
                                                  5, 1997, which represents the IDE                                                                              Act, FDA must publish in the Federal
                                                  effective date.                                          Medical Devices; Exemptions From                      Register a list representing its final
                                                     2. The date an application was                        Premarket Notification: Class II                      determination regarding the list of
                                                  initially submitted with respect to the                  Devices                                               devices proposed in the March 14, 2017,
                                                  biological device under section 515 of                                                                         notice. Section 510(m)(3) of the FD&C
                                                                                                           AGENCY:    Food and Drug Administration,              Act provides that upon the date that this
                                                  the FD&C Act (21 U.S.C. 360e):                           HHS.
                                                  November 29, 2013. The applicant                                                                               final list is published in the Federal
                                                  claims December 23, 2013, as the date                    ACTION:   Notice.                                     Register, a 510(k) will no longer be
                                                  the premarket approval application                                                                             required for the listed devices and the
                                                                                                           SUMMARY:   The Food and Drug                          applicable classification regulation for
                                                  (PMA) for INTERCEPT BLOOD                                Administration (FDA or Agency) is
                                                  SYSTEM FOR PLASMA (PMA                                                                                         these devices shall be deemed amended
                                                                                                           announcing a list of class II devices that            to incorporate such exemption.
                                                  BP130076) was initially submitted.                       the Agency has determined based on
                                                  However, FDA records indicate that the                                                                         Interested persons were given until May
                                                                                                           established factors to no longer require              15, 2017, to comment on the proposed
                                                  complete PMA BP130076 was submitted                      premarket notification to provide
                                                  on November 29, 2013.                                                                                          list of class II devices. After reviewing
                                                                                                           reasonable assurance of safety and                    these comments and considering
                                                     3. The date the application was                       effectiveness, subject to certain                     whether the proposed list should be
                                                  approved: December 16, 2014. FDA has                     limitations. FDA is publishing this                   modified, FDA is now identifying its
                                                  verified the applicant’s claim that PMA                  notice of that determination in                       final determination as to which of those
                                                  BP130076 was approved on December                        accordance with procedures established                devices are now exempt from premarket
                                                  16, 2014.                                                by the 21st Century Cures Act. This                   notification requirements, subject to
                                                     This determination of the regulatory                  notice represents FDA’s final                         certain limitations, as indicated in
                                                  review period establishes the maximum                    determination with respect to the list of             tables 1 to 3 of this notice.
                                                  potential length of a patent extension.                  class II devices proposed in a March 14,
                                                                                                                                                                    In a future action, FDA intends to
                                                  However, the USPTO applies several                       2017, Federal Register document. The
                                                                                                                                                                 amend the codified language for each
                                                  statutory limitations in its calculations                exemptions in this notice will decrease
                                                                                                                                                                 listed device’s classification regulation
                                                  of the actual period for patent extension.               regulatory burdens on the medical
                                                                                                                                                                 to reflect this final determination.
                                                  In its applications for patent extension,                device industry and will eliminate
                                                                                                                                                                 Persons with pending 510(k)
                                                  this applicant seeks 1,860 days or 5                     private costs and expenditures required
                                                                                                                                                                 submissions for devices that are now
                                                  years of patent term extension.                          to comply with certain Federal
                                                                                                                                                                 exempt from premarket notification,
                                                                                                           regulations.
                                                  III. Petitions                                                                                                 subject to the limitations on
                                                                                                           FOR FURTHER INFORMATION CONTACT:                      exemptions, should withdraw their
                                                    Anyone with knowledge that any of                      Bryce Bennett, Center for Devices and                 submissions.
                                                  the dates as published are incorrect may                 Radiological Health, Food and Drug                       These exemptions will decrease
                                                  submit either electronic or written                      Administration, 10903 New Hampshire                   regulatory burdens on the medical
                                                  comments and, under 21 CFR 60.24, ask                    Ave., Bldg. 66, Rm. 5244, Silver Spring,              device industry and will eliminate
                                                  for a redetermination (see DATES).                       MD 20993, email: Gregory.Bennett@                     private costs and expenditures required
                                                  Furthermore, as specified in 21 CFR                      fda.hhs.gov.                                          to comply with Federal regulation.
                                                  60.30, any interested person may                         SUPPLEMENTARY INFORMATION:                            Specifically, regulated industry will no
                                                  petition FDA for a determination                                                                               longer have to invest time and resources
                                                  regarding whether the applicant for                      I. Background                                         in premarket notifications, including
                                                  extension acted with due diligence                          In the Federal Register of March 14,               preparation of documents and data for
                                                  during the regulatory review period. To                  2017 (82 FR 13609), FDA issued a notice               submission to FDA, payment of user
                                                  meet its burden, the petition must be                    proposing to exempt a list of class II                fees associated with 510(k) submissions,
                                                  timely (see DATES) and contain sufficient                devices from the premarket notification               and responding to questions and
                                                  facts to merit an FDA investigation. (See                requirements under section 510(k) of the              requests for additional information from
                                                  H. Rept. 857, part 1, 98th Cong., 2d                     Federal Food, Drug, and Cosmetic Act                  FDA during 510(k) review.
                                                  sess., pp. 41–42, 1984.) Petitions should                (the FD&C Act) (21 U.S.C. 360(k)),
                                                                                                                                                                 II. Criteria for Exemption
                                                  be in the format specified in 21 CFR                     subject to certain limitations. This
                                                  10.30.                                                   notice was issued in accordance with                     There are a number of factors FDA
                                                    Submit petitions electronically to                     the 21st Century Cures Act (Pub. L. 114–              may consider to determine whether a
                                                  https://www.regulations.gov at Docket                    255), which was signed into law on                    510(k) is necessary to provide
                                                  No. FDA–2013–S–0610. Submit written                      December 13, 2016. Section 3054 of that               reasonable assurance of the safety and
                                                  petitions (two copies are required) to the               statute amended section 510(m) of the                 effectiveness of a class II device. These
                                                  Dockets Management Staff (see                            FD&C Act. As amended, section                         factors are discussed in the January 21,
                                                                                                           510(m)(1)(A) of the FD&C Act provides                 1998, Federal Register notice (63 FR
mstockstill on DSK30JT082PROD with NOTICES




                                                  ADDRESSES).
                                                                                                           that, within 90 days after enactment of               3142) and subsequently in the guidance
                                                    Dated: July 5, 2017.                                   the 21st Century Cures Act and at least               the Agency issued on February 19, 1998,
                                                  Anna K. Abram,                                           once every 5 years thereafter, FDA must               entitled ‘‘Procedures for Class II Device
                                                  Deputy Commissioner for Policy, Planning,                publish in the Federal Register a notice              Exemptions from Premarket
                                                  Legislation, and Analysis.                               containing a list of each type of class II            Notification, Guidance for Industry and
                                                  [FR Doc. 2017–14454 Filed 7–10–17; 8:45 am]              device that FDA determines no longer                  CDRH Staff’’ (‘‘Class II 510(k)
                                                  BILLING CODE 4164–01–P                                   requires a report under section 510(k) of             Exemption Guidance’’) (Ref. 1).


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                                                                                       Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                                                            31977

                                                  III. Limitations on Exemptions                                       limit the exemption from premarket                                         exemptions found in §§ 862.9 to 892.9).
                                                                                                                       notification requirements to specific                                      In table 2, for example, FDA is listing
                                                     FDA believes that the types of class II                           devices within a listed device type. In                                    the exemption of the tympanometer but
                                                  devices listed in this notice should be                              such situations where a partial                                            limits the exemption to such devices
                                                  exempt from the premarket notification                               exemption limitation has been                                              that are in compliance with FDA-
                                                  requirements found under section                                     identified, FDA has determined that                                        recognized consensus standard ANSI
                                                  510(k) of the FD&C Act. However, an                                  premarket notification is necessary to                                     S3.39. Tympanometers that comply
                                                  exemption from the requirement of                                    provide a reasonable assurance of safety
                                                  premarket notification does not mean                                                                                                            with this partial exemption limitation
                                                                                                                       and effectiveness for these devices.                                       and the corresponding general
                                                  that the device is exempt from any other                             Partial exemption limitations can be
                                                  statutory or regulatory requirements,                                                                                                           limitations in § 874.9 are now exempt
                                                                                                                       found in table 2 of this notice. FDA has                                   from the 510(k) requirements and
                                                  unless such exemption is explicitly                                  assigned new product codes to the
                                                  provided by order or regulation. FDA’s                                                                                                          should be identified under new product
                                                                                                                       device types that are now exempt                                           code ‘‘PTP’’ in subsequent registration
                                                  determination that premarket                                         subject to the partial limitations in order
                                                  notification is unnecessary to provide a                                                                                                        and listing submissions. However,
                                                                                                                       to ensure that these devices can be                                        tympanometers not in compliance with
                                                  reasonable assurance of safety and                                   separated from devices that do not fall
                                                  effectiveness for devices listed in this                                                                                                        each of these exemption limitations
                                                                                                                       within the partial exemption limitation
                                                  document is based, in part, on the                                                                                                              remain subject to the 510(k)
                                                                                                                       under the existing product code (i.e.,
                                                  assurance of safety and effectiveness                                                                                                           requirements and will retain product
                                                                                                                       exempt and non-exempt devices within
                                                  that other regulatory controls, such as                                                                                                         code ‘‘NAS.’’ We recommend that
                                                                                                                       a device type will have distinct product
                                                  current good manufacturing practice                                  codes). If table 2 indicates that a partial                                device manufacturers document in their
                                                  requirements, provide.                                               exemption limitation does apply to a                                       records any changes in the product code
                                                     In addition to being subject to the                               device, then affected device                                               of their device with appropriate
                                                  general limitations to the exemptions                                manufacturers should review their                                          justification.
                                                  found in Title 21 of the Code of Federal                             registration and listing information to                                    IV. List of Class II Devices
                                                  Regulations (CFR) sections 862.9 to                                  assess if they should list their device
                                                  892.9 (§§ 862.9 to 892.9), when Agency                               using the original classification product                                    In table 1, FDA is identifying the
                                                  assessment determines that the factors                               code, which requires premarket                                             following list of class II devices that no
                                                  laid out in the Class II 510(k) Exemption                            notification, or the new classification                                    longer require premarket notification
                                                  Guidance (Ref. 1) do not weigh in favor                              product code for the subset of that                                        under section 510(k) of the FD&C Act,
                                                  of exemption for all devices in a                                    device type that is now 510(k) exempt                                      subject to the general limitations to the
                                                  particular group, FDA may partially                                  (subject to the general limitations to the                                 exemptions found in §§ 862.9 to 892.9:

                                                                                                                                 TABLE 1—CLASS II DEVICES
                                                                                                                                                                                                                                                         Product
                                                   21 CFR section                                                                                      Device type                                                                                        code

                                                  862.1020   ...........   Acid Phosphatase, Nitrophenylphosphate ...................................................................................................................                    CJN
                                                  862.1020   ...........   Acid Phosphatase, Thymol Blue Monophosphate .......................................................................................................                           CJR
                                                  862.1020   ...........   Acid Phosphatase, Disodium Phenylphosphate ..........................................................................................................                         CJX
                                                  862.1020   ...........   Acid Phosphatase, Naphthyl Phosphate .....................................................................................................................                    CKB
                                                  862.1020   ...........   Acid Phosphatase, Thymolphthale Inmonophosphate ................................................................................................                              CKE
                                                  862.1020   ...........   Acid Phosphatase, Beta Glycerophosphate ................................................................................................................                      CKH
                                                  862.1020   ...........   Acid Phosphatase (Prostatic), Tartrate Inhibited .........................................................................................................                    JFH
                                                  862.1090   ...........   Radioassay, Angiotensin Converting Enzyme .............................................................................................................                       KQN
                                                  862.1100   ...........   Vanillin Pyruvate, AST/SGOT ......................................................................................................................................            CIF
                                                  862.1100   ...........   Diazo, AST/SGOT .......................................................................................................................................................       CIQ
                                                  862.1100   ...........   Hydrazone Colorimetry, AST/SGOT ............................................................................................................................                  CIS
                                                  862.1100   ...........   NADH Oxidation/NAD Reduction, AST/SGOT ............................................................................................................                           CIT
                                                  862.1150   ...........   Calibrator, Primary .......................................................................................................................................................   JIS
                                                  862.1150   ...........   Calibrator, Secondary ..................................................................................................................................................      JIT
                                                  862.1150   ...........   Calibrator, Surrogate ...................................................................................................................................................     JIW
                                                  862.1150   ...........   Calibrator, Multi-Analyte Mixture ..................................................................................................................................          JIX
                                                  862.1345   ...........   Drink, Glucose Tolerance ............................................................................................................................................         MRV
                                                  862.1350   ...........   Continuous Glucose Monitor Secondary Display ........................................................................................................                         PJT
                                                  862.1445   ...........   Chromatographic Separation, Lactate Dehydrogenase Isoenzymes ..........................................................................                                       CEX
                                                  862.1445   ...........   Electrophoretic, Lactate Dehydrogenase Isoenzymes ................................................................................................                            CFE
                                                  862.1445   ...........   Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes .....................................................................                                      JGF
                                                  862.1509   ...........   System, Test, Urinary Methylmalonic Acid ..................................................................................................................                   LPT
                                                  862.1685   ...........   Radioimmunoassay, Thyroxine-Binding Globulin ........................................................................................................                         CEE
                                                  862.1700   ...........   Radioimmunoassay, Total Thyroxine ..........................................................................................................................                  CDX
                                                  862.1700   ...........   Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine ......................................................................................                                  KLI
                                                  862.2265   ...........   High Throughput DNA Sequence Analyzer .................................................................................................................                       PFF
                                                  862.2570   ...........   Instrumentation For Clinical Multiplex Test Systems ..................................................................................................                        NSU
mstockstill on DSK30JT082PROD with NOTICES




                                                  862.2570   ...........   Real Time Nucleic Acid Amplification System .............................................................................................................                     OOI
                                                  862.2570   ...........   Mass Spectrometer For Clinical Multiplex Test Systems ............................................................................................                            OTA
                                                  862.2570   ...........   Micro Total Analysis Instrument System .....................................................................................................................                  OUE
                                                  862.2570   ...........   Complete Gene Expression Profiling Accessory Reagents ........................................................................................                                OVA
                                                  862.2570   ...........   DNA Genetic Analyzer .................................................................................................................................................        PCA
                                                  862.2570   ...........   Data Acquisition Software ...........................................................................................................................................         PQQ
                                                  862.3200   ...........   Calibrators, Drug Mixture .............................................................................................................................................       DKB
                                                  862.3200   ...........   Calibrators, Drug Specific ............................................................................................................................................       DLJ



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                                                  31978                                 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                       TABLE 1—CLASS II DEVICES—Continued
                                                                                                                                                                                                                                                                Product
                                                   21 CFR section                                                                                         Device type                                                                                            code

                                                  862.3200   ...........   Calibrators, Ethyl Alcohol ............................................................................................................................................              DNN
                                                  864.5400   ...........   Fibrometer ....................................................................................................................................................................      GIE
                                                  864.5400   ...........   Timer, Coagulation ......................................................................................................................................................            JBT
                                                  864.5425   ...........   Control, Plasma, Abnormal ..........................................................................................................................................                 GGC
                                                  864.5425   ...........   Plasma, Coagulation Control .......................................................................................................................................                  GGN
                                                  864.5425   ...........   Plasma, Control, Normal .............................................................................................................................................                GIZ
                                                  864.6550   ...........   Control, Fecal Occult Blood .........................................................................................................................................                OSL
                                                  864.6650   ...........   Study, Platelet Adhesive ..............................................................................................................................................              JBZ
                                                  864.7275   ...........   Test, Euglobulin Lysis ..................................................................................................................................................            JBO
                                                  864.7300   ...........   Fibrin Monomer Paracoagulation ................................................................................................................................                      JBN
                                                  864.7340   ...........   Fibrinogen Standard ....................................................................................................................................................             GFX
                                                  864.7340   ...........   Plasma, Fibrinogen Control .........................................................................................................................................                 GIL
                                                  864.7375   ...........   Glutathione, Red-Cell ..................................................................................................................................................             GII
                                                  864.7375   ...........   Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase ...................................................................                                            JMH
                                                  864.7375   ...........   Assay, Glutathione Reductase ....................................................................................................................................                    KQF
                                                  864.7415   ...........   Control, Hemoglobin, Abnormal ...................................................................................................................................                    JCM
                                                  864.7455   ...........   Stain, Fetal Hemoglobin ..............................................................................................................................................               GHQ
                                                  864.7500   ...........   Acid Hematin ...............................................................................................................................................................         GGF
                                                  864.7720   ...........   Test, Prothrombin Consumption ..................................................................................................................................                     GGQ
                                                  864.7735   ...........   Prothrombin-Proconvertin and Thrombotest ................................................................................................................                            JPF
                                                  864.8150   ...........   Calibrator for Cell Indices ............................................................................................................................................             KRX
                                                  864.8165   ...........   Calibrator for Hemoglobin and Hematocrit Measurement ...........................................................................................                                     KRZ
                                                  864.8175   ...........   Calibrator for Platelet Counting ...................................................................................................................................                 KRY
                                                  864.8185   ...........   Calibrator for Red-Cell and White-Cell Counting ........................................................................................................                             KSA
                                                  864.8625   ...........   Standards and Controls, Hemoglobin, Normal and Abnormal ....................................................................................                                         GFS
                                                  864.8625   ...........   Control, White-Cell .......................................................................................................................................................          GGL
                                                  864.8625   ...........   Control, Hemoglobin ....................................................................................................................................................             GGM
                                                  864.8625   ...........   Control, Platelet ...........................................................................................................................................................        GJP
                                                  864.8625   ...........   Control, Red-Cell .........................................................................................................................................................          GJR
                                                  864.8625   ...........   Control, Hematocrit ......................................................................................................................................................           GLK
                                                  864.8625   ...........   Mixture, Control, White-Cell and Red-Cell Indices ......................................................................................................                             GLQ
                                                  864.8625   ...........   Control, Cell Counter, Normal and Abnormal ..............................................................................................................                            JCN
                                                  864.8625   ...........   Mixture, Hematology Quality Control ...........................................................................................................................                      JPK
                                                  864.8625   ...........   Material, Quality Control, Semen Analysis ..................................................................................................................                         NRF
                                                  864.8625   ...........   Control Material, Blood Circulating Epithelial Cancer Cell ..........................................................................................                                NRS
                                                  864.9400   ...........   Solution, Stabilized Enzyme ........................................................................................................................................                 KSK
                                                  866.3395   ...........   Norovirus Serological Reagents ..................................................................................................................................                    OUC
                                                  866.5210   ...........   Immunochemical, Ceruloplasmin .................................................................................................................................                      CHN
                                                  866.5210   ...........   Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control ...........................................................................................                                    DCT
                                                  866.5210   ...........   Ceruloplasmin, FITC, Antigen, Antiserum, Control .....................................................................................................                               DCY
                                                  866.5210   ...........   Ceruloplasmin, Antigen, Antiserum, Control ................................................................................................................                          DDB
                                                  866.5210   ...........   P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin ............................................................................                                            JFQ
                                                  866.5210   ...........   Indirect Copper Assay, Ceruloplasmin ........................................................................................................................                        JFR
                                                  866.5470   ...........   Hemoglobin, Chain Specific, Antigen, Antiserum, Control ..........................................................................................                                   DAM
                                                  866.5620   ...........   Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control ..............................................................................                                         DDT
                                                  866.5620   ...........   Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control ........................................................................................                                    DDY
                                                  866.5620   ...........   Alpha-2-Macroglobulin, Antigen, Antiserum, Control ...................................................................................................                               DEB
                                                  866.5630   ...........   System, Test, Beta-2-Microglobulin Immunological ....................................................................................................                                JZG
                                                  866.5910   ...........   Quality Control Material, Genetics, DNA .....................................................................................................................                        NZB
                                                  868.1040   ...........   Algesimeter, Powered ..................................................................................................................................................              BSI
                                                  868.1400   ...........   Legging, Compression, Non-Inflatable ........................................................................................................................                        LLK
                                                  868.2500   ...........   Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia .........................................................................                                            KLK
                                                  868.2500   ...........   Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia .....................................                                                            LPP
                                                  868.2550   ...........   Pneumotachometer ......................................................................................................................................................              JAX
                                                  868.5180   ...........   Bed, Rocking, Breathing Assist ...................................................................................................................................                   CCO
                                                  868.6250   ...........   Compressor, Air, Portable ...........................................................................................................................................                BTI
                                                  870.1390   ...........   Trocar ...........................................................................................................................................................................   DRC
                                                  870.1875   ...........   Lung Sound Monitor ....................................................................................................................................................              OCR
                                                  870.2675   ...........   Oscillometer .................................................................................................................................................................       DRZ
                                                  870.4280   ...........   Filter, Prebypass, Cardiopulmonary Bypass ...............................................................................................................                            KRJ
                                                  870.4290   ...........   Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass .................................................................................                                       DTL
                                                  870.4340   ...........   Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass .............................................................................                                          DTW
                                                  870.4420   ...........   Sucker, Cardiotomy Return, Cardiopulmonary Bypass ...............................................................................................                                    DTS
mstockstill on DSK30JT082PROD with NOTICES




                                                  870.4430   ...........   Suction Control, Intracardiac, Cardiopulmonary Bypass .............................................................................................                                  DWD
                                                  872.1720   ...........   Tester, Pulp .................................................................................................................................................................       EAT
                                                  872.3260   ...........   External Cleaning Solution ..........................................................................................................................................                PME
                                                  872.3300   ...........   Coating, Denture Hydrophilic, Resin ...........................................................................................................................                      EBE
                                                  872.3540   ...........   Pad, Denture, Over The Counter ................................................................................................................................                      EHR
                                                  872.3540   ...........   Cushion, Denture, Over The Counter .........................................................................................................................                         EHS
                                                  872.3560   ...........   Reliner, Denture, Over The Counter ...........................................................................................................................                       EBP
                                                  872.3590   ...........   Denture, Plastic, Tooth ................................................................................................................................................             ELM



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                                                                                        Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                                                                31979

                                                                                                                      TABLE 1—CLASS II DEVICES—Continued
                                                                                                                                                                                                                                                              Product
                                                   21 CFR section                                                                                        Device type                                                                                           code

                                                  872.3600   ...........   Denture Preformed (Partially Prefabricated Denture) .................................................................................................                              EKO
                                                  872.3890   ...........   Splint, Endodontic Stabilizing ......................................................................................................................................              ELS
                                                  872.5550   ...........   Ring, Teething, Fluid-Filled ..........................................................................................................................................            KKO
                                                  872.6770   ...........   Syringe, Cartridge ........................................................................................................................................................        EJI
                                                  874.1120   ...........   Generator, Electronic Noise (for Audiometric Testing) ................................................................................................                             ETS
                                                  874.1325   ...........   Electroglottograph ........................................................................................................................................................        KLX
                                                  874.3310   ...........   Calibrator, Hearing Aid/Earphone and Analysis Systems ...........................................................................................                                  ETW
                                                  874.3320   ...........   Hearing Aid, Group and Auditory Trainer ....................................................................................................................                       EPF
                                                  874.3320   ...........   Device, Assistive Listening ..........................................................................................................................................             LZI
                                                  874.3330   ...........   Hearing Aid, Master .....................................................................................................................................................          KHL
                                                  874.3430   ...........   Mold, Middle-Ear ..........................................................................................................................................................        ETC
                                                  874.3730   ...........   Device, Voice Amplification .........................................................................................................................................              MCK
                                                  876.1500   ...........   Light Source, Incandescent, Diagnostic ......................................................................................................................                      FCQ
                                                  876.1500   ...........   Light Source, Photographic, Fiberoptic .......................................................................................................................                     FCR
                                                  876.1500   ...........   Light Source, Fiberoptic, Routine ................................................................................................................................                 FCW
                                                  876.1500   ...........   Carrier, Sponge, Endoscopic .......................................................................................................................................                FGS
                                                  876.1500   ...........   Light Source, Endoscope, Xenon Arc .........................................................................................................................                       GCT
                                                  876.1500   ...........   Transformer, Endoscope .............................................................................................................................................               GCW
                                                  876.1500   ...........   LED Light Source ........................................................................................................................................................          NTN
                                                  876.1500   ...........   Endoscopic Guide Wire, Gastroenterology-Urology ....................................................................................................                               OCY
                                                  876.4020   ...........   Light, Catheter, Fiberoptic, Glass, Ureteral .................................................................................................................                     FCS
                                                  876.4270   ...........   Rod, Colostomy ...........................................................................................................................................................         EZP
                                                  876.4400   ...........   Ligator, Hemorrhoidal ..................................................................................................................................................           FHN
                                                  876.4400   ...........   Ligator, Esophageal .....................................................................................................................................................          MND
                                                  876.4500   ...........   Lithotriptor, Biliary Mechanical .....................................................................................................................................             LQC
                                                  876.4770   ...........   Urethrotome .................................................................................................................................................................      EZO
                                                  876.5010   ...........   Bag, Bile Collecting .....................................................................................................................................................         EXF
                                                  876.5025   ...........   Vibrator for Climax Control of Premature Ejaculation .................................................................................................                             PIA
                                                  876.5365   ...........   Dilator, Esophageal (Metal Olive) Gastro-Urology ......................................................................................................                            EZM
                                                  876.5365   ...........   Bougie, Esophageal, and Gastrointestinal, Gastro-Urology ........................................................................................                                  FAT
                                                  876.5365   ...........   Dilator, Esophageal .....................................................................................................................................................          KNQ
                                                  876.5520   ...........   Dilator, Urethral ............................................................................................................................................................     KOE
                                                  876.5665   ...........   Disinfectant, Subsystem, Water Purification ................................................................................................................                       NIH
                                                  876.5820   ...........   Set, Dialyzer Holder .....................................................................................................................................................         FKI
                                                  876.5895   ...........   Irrigator, Ostomy ..........................................................................................................................................................       EXD
                                                  876.5980   ...........   Catheter, Retention, Barium Enema With Bag ............................................................................................................                            FGD
                                                  876.5980   ...........   Gastrostomy Tube Holder ...........................................................................................................................................                PLI
                                                  878.4370   ...........   Drape, Surgical, ENT ...................................................................................................................................................           ERY
                                                  878.4370   ...........   Drape, Pure Latex Sheet, With Self-Retaining Finger Cot ..........................................................................................                                 EYX
                                                  878.4370   ...........   Drape, Urological, Disposable .....................................................................................................................................                EYY
                                                  878.4370   ...........   Pad, Kelly .....................................................................................................................................................................   FNW
                                                  878.4370   ...........   Drape, Patient, Ophthalmic .........................................................................................................................................               HMT
                                                  878.4370   ...........   Drape, Microscope, Ophthalmic ..................................................................................................................................                   HMW
                                                  878.4370   ...........   Ring (Wound Protector), Drape Retention, Internal ....................................................................................................                             KGW
                                                  878.4580   ...........   Lamp, Operating-Room ...............................................................................................................................................               FQP
                                                  878.4580   ...........   Light, Surgical, Instrument ...........................................................................................................................................            FSQ
                                                  878.4580   ...........   Light, Surgical, Floor Standing ....................................................................................................................................               FSS
                                                  878.4580   ...........   Light, Surgical, Endoscopic .........................................................................................................................................              FSW
                                                  878.4580   ...........   Light, Surgical, Connector ...........................................................................................................................................             FSX
                                                  878.4580   ...........   Light, Surgical, Ceiling Mounted ..................................................................................................................................                FSY
                                                  878.4580   ...........   Light, Surgical, Carrier .................................................................................................................................................         FSZ
                                                  878.4580   ...........   Light, Surgical, Accessories ........................................................................................................................................              FTA
                                                  878.4580   ...........   Lamp, Surgical .............................................................................................................................................................       FTD
                                                  878.4580   ...........   Illuminator, Remote ......................................................................................................................................................         FTG
                                                  878.4580   ...........   Lamp, Surgical, Incandescent .....................................................................................................................................                 GBC
                                                  878.5070   ...........   Apparatus, Air Handling, Bench ..................................................................................................................................                  FZG
                                                  878.5070   ...........   Apparatus, Air Handling, Room ...................................................................................................................................                  FZH
                                                  878.5070   ...........   Apparatus, Air Handling, Enclosure .............................................................................................................................                   FZI
                                                  880.5580   ...........   Locator, Acupuncture Point .........................................................................................................................................               BWJ
                                                  880.5580   ...........   Needle, Acupuncture, Single Use ...............................................................................................................................                    MQX
                                                  880.5780   ...........   Stocking, Medical Support (to Prevent Pooling of Blood in Legs) ..............................................................................                                     DWL
                                                  882.1020   ...........   Analyzer, Rigidity .........................................................................................................................................................       GZM
                                                  882.1540   ...........   Device, Galvanic Skin Response Measurement .........................................................................................................                               GZO
mstockstill on DSK30JT082PROD with NOTICES




                                                  882.1560   ...........   Device, Skin Potential Measurement ...........................................................................................................................                     HCJ
                                                  882.1855   ...........   Encephalogram Telemetry System ..............................................................................................................................                      GYE
                                                  882.5895   ...........   Vibratory Counter-Stimulation ......................................................................................................................................               OVP
                                                  884.2990   ...........   Sheet, Recording, Breast Examination ........................................................................................................................                      NHM
                                                  884.3200   ...........   Drain, Cervical .............................................................................................................................................................      HFL
                                                  884.4400   ...........   Forceps, Obstetrical .....................................................................................................................................................         HDA
                                                  884.4530   ...........   Clamp, Umbilical ..........................................................................................................................................................        HFW
                                                  884.4530   ...........   Speculum, Vaginal, Nonmetal .....................................................................................................................................                  HIB



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                                                  31980                                 Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                      TABLE 1—CLASS II DEVICES—Continued
                                                                                                                                                                                                                                                             Product
                                                   21 CFR section                                                                                        Device type                                                                                          code

                                                  884.4530   ...........   Speculum, Vaginal, Nonmetal, Fiberoptic ...................................................................................................................                       HIC
                                                  884.4530   ...........   Clamp and Cutter, Umbilical ........................................................................................................................................              NBZ
                                                  884.4900   ...........   Table, Obstetrical, AC-Powered (and Accessories) ....................................................................................................                             HDD
                                                  884.4900   ...........   Table, Obstetrical, Manual (and Accessories) .............................................................................................................                        HHP
                                                  884.4900   ...........   Table, Obstetric (and Accessories) .............................................................................................................................                  KNC
                                                  884.5200   ...........   Hemorrhoid Prevention Pressure Wedge ....................................................................................................................                         OOA
                                                  884.5390   ...........   Heater, Perineal, Direct Contact ..................................................................................................................................               HGZ
                                                  884.5390   ...........   Heater, Perineal, Radiant, Non-Contact ......................................................................................................................                     HHA
                                                  884.5390   ...........   Heater, Perineal ...........................................................................................................................................................      KND
                                                  884.5400   ...........   Cup, Menstrual ............................................................................................................................................................       HHE
                                                  884.5425   ...........   Pad, Menstrual, Scented .............................................................................................................................................             HHL
                                                  884.6150   ...........   Micromanipulators and Microinjectors, Assisted Reproduction ...................................................................................                                   MQJ
                                                  886.1120   ...........   Photorefractor ..............................................................................................................................................................     MMF
                                                  886.1120   ...........   Camera, Ophthalmic, General-Use .............................................................................................................................                     PJZ
                                                  886.1250   ...........   Euthyscope, AC-Powered ............................................................................................................................................               HMK
                                                  886.1570   ...........   Ophthalmoscope, AC-Powered ...................................................................................................................................                    HLI
                                                  886.1570   ...........   Ophthalmoscope, Battery-Powered .............................................................................................................................                     HLJ
                                                  886.1570   ...........   Ophthalmoscopes, Replacement Batteries, Hand-Held ..............................................................................................                                  MSG
                                                  886.1780   ...........   Retinoscope, AC-Powered ..........................................................................................................................................                HKL
                                                  886.1945   ...........   Transilluminator, AC-Powered .....................................................................................................................................                HJM
                                                  886.4150   ...........   Tubing, Replacement, Phacofragmentation Unit .........................................................................................................                            MSR
                                                  886.4250   ...........   Unit, Electrolysis, AC-Powered, Ophthalmic ...............................................................................................................                        HRO
                                                  886.4335   ...........   Headlight, Fiberoptic Focusing ....................................................................................................................................               FCT
                                                  886.4335   ...........   Light, Headband, Surgical ...........................................................................................................................................             FSR
                                                  886.4335   ...........   Headlamp, Operating, AC-Powered ............................................................................................................................                      HPQ
                                                  886.4400   ...........   Locator, Metal, Electronic ............................................................................................................................................           HPM
                                                  886.4440   ...........   Magnet, AC-Powered ..................................................................................................................................................             HPO
                                                  886.4790   ...........   Sponge, Ophthalmic ....................................................................................................................................................           HOZ
                                                  886.4790   ...........   Eye Tray ......................................................................................................................................................................   OJK
                                                  888.1240   ...........   Dynamometer, AC-Powered ........................................................................................................................................                  LBB
                                                  888.4580   ...........   Instrument, Surgical, Sonic and Accessory/Attachment ..............................................................................................                               JDX
                                                  888.4580   ...........   System, Cement Removal Extraction ..........................................................................................................................                      LZV
                                                  890.1450   ...........   Hammer, Reflex, Powered ..........................................................................................................................................                IKO
                                                  890.5100   ...........   Bath, Hydro-Massage ..................................................................................................................................................            ILJ
                                                  890.5100   ...........   Bath, Sitz, Powered .....................................................................................................................................................         ILM
                                                  890.5110   ...........   Bath, Paraffin ...............................................................................................................................................................    IMC
                                                  890.5250   ...........   Cabinet, Moist Steam ..................................................................................................................................................           IMB
                                                  890.5360   ...........   Exerciser, Measuring ...................................................................................................................................................          ISD
                                                  890.5500   ...........   Lamp, Infrared, Therapeutic Heating ...........................................................................................................................                   ILY
                                                  890.5575   ...........   Device, Warning, Overload, External Limb, Powered .................................................................................................                               IRN
                                                  892.1000   ...........   MRI Disposable Kit ......................................................................................................................................................         OIM
                                                  892.1560   ...........   Biopsy Needle Guide Kit .............................................................................................................................................             OIJ
                                                  892.1610   ...........   Aperature, Radiographic ..............................................................................................................................................            IZS
                                                  892.1610   ...........   Cone, Radiographic .....................................................................................................................................................          IZT
                                                  892.1610   ...........   Collimator, Automatic, Radiographic ...........................................................................................................................                   IZW
                                                  892.1610   ...........   Collimator, Manual, Radiographic ................................................................................................................................                 IZX
                                                  892.1610   ...........   Device, Beam Limiting, X-Ray, Diagnostic ..................................................................................................................                       KPW
                                                  892.1650   ...........   Arthrogram Tray ...........................................................................................................................................................       OII
                                                  892.1650   ...........   Radiology Dental Tray .................................................................................................................................................           OIK
                                                  892.1670   ...........   Device, Spot-Film ........................................................................................................................................................        IXL
                                                  892.1680   ...........   Radiographic Contrast Tray .........................................................................................................................................              OIO
                                                  892.1680   ...........   Radiology Diagnostic Kit ..............................................................................................................................................           OIP
                                                  892.1730   ...........   Discography Kit ............................................................................................................................................................      OIL
                                                  892.1820   ...........   Chair, Pneumocephalographic ....................................................................................................................................                  HBK
                                                  892.1850   ...........   Cassette, Radiographic Film ........................................................................................................................................              IXA
                                                  892.1860   ...........   Changer, Radiographic Film/Cassette .........................................................................................................................                     KPX
                                                  892.1870   ...........   Programmer, Changer, Film/Cassette, Radiographic ..................................................................................................                               IZP
                                                  892.1900   ...........   Controller, Temperature, Radiographic .......................................................................................................................                     EGT
                                                  892.1900   ...........   Dryer, Film, Radiographic ............................................................................................................................................            EGW
                                                  892.1900   ...........   Processor, Radiographic-Film, Automatic, Dental .......................................................................................................                           EGY
                                                  892.1900   ...........   Processor, Radiographic-Film, Automatic ...................................................................................................................                       IXW
                                                  892.1900   ...........   Processor, Cine Film ...................................................................................................................................................          IXX
                                                  892.2030   ...........   Digitizer, Image, Radiological ......................................................................................................................................             LMA
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                                                  892.2030   ...........   Digitizer, Images, Ophthalmic ......................................................................................................................................              NFH
                                                  892.2040   ...........   Camera, Multi Format, Radiological ............................................................................................................................                   LMC
                                                  892.2040   ...........   Device, Hardcopy, Images, Ophthalmic ......................................................................................................................                       NFI
                                                  892.5730   ...........   Prostate Seeding Kit ....................................................................................................................................................         OIN




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                                                                                  Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                        31981

                                                    In table 2, FDA is identifying a list of               found in §§ 862.9 to 892.9, as well as the                   partial exemption limitation specified in
                                                  class II devices that no longer require                  indicated partial exemption limitations.                     table 2 and its corresponding general
                                                  premarket notification under section                     Devices listed in table 2 are now                            limitation found in the .9 section of
                                                  510(k) of the FD&C Act, subject to the                   exempt, but only if they are in                              Parts 862 to 892 of Title 21 of the CFR.
                                                  general limitations to the exemptions                    concurrent compliance with both the

                                                                                                                   TABLE 2—CLASS II DEVICES
                                                                                                                                      Former
                                                                                                                   Exempt             product
                                                  21 CFR Section                 Device type                                                                                Partial exemption limitation
                                                                                                                product code           code
                                                                                                                                   (non-exempt)

                                                  862.3100 .........   Enzyme Immunoassay, Am-              PUX ...............   DKZ ................     Exemption is limited to test systems intended for employ-
                                                                         phetamine.                                                                          ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3100 .........   Radioimmunoassay, Amphet-            PUX ...............   DJP ................     Exemption is limited to test systems intended for employ-
                                                                        amine.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3100 .........   Thin Layer Chromatography,           PUX ...............   DIT .................    Exemption is limited to test systems intended for employ-
                                                                         Amphetamine.                                                                        ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3100 .........   Gas Chromatography, Am-              PUX ...............   DOD ...............      Exemption is limited to test systems intended for employ-
                                                                        phetamine.                                                                           ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3100 .........   Liquid Chromatography, Am-           PUX ...............   DNI .................    Exemption is limited to test systems intended for employ-
                                                                         phetamine.                                                                          ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3100 .........   Free Radical Assay, Amphet-          PUX ...............   DJL .................    Exemption is limited to test systems intended for employ-
                                                                         amine.                                                                              ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3150 .........   Enzyme Immunoassay, Bar-             PUY ...............   DIS .................    Exemption is limited to test systems intended for employ-
                                                                         biturate.                                                                           ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
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                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)




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                                                  31982                           Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                      Former
                                                                                                                   Exempt             product
                                                  21 CFR Section                 Device type                                                                               Partial exemption limitation
                                                                                                                product code           code
                                                                                                                                   (non-exempt)

                                                  862.3150 .........   Radioimmunoassay, Barbitu-           PUY ...............   DKN ...............     Exemption is limited to test systems intended for employ-
                                                                        rate.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3150 .........   Thin Layer Chromatography,           PUY ...............   DKX ................    Exemption is limited to test systems intended for employ-
                                                                         Barbiturate.                                                                       ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3150 .........   Mercury Dithiazone, Colorim-         PUY ...............   DJN ................    Exemption is limited to test systems intended for employ-
                                                                        etry, Barbiturate.                                                                  ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3150 .........   Hemagglutination Inhibition,         PUY ...............   DLX ................    Exemption is limited to test systems intended for employ-
                                                                        Barbiturate.                                                                        ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3150 .........   Gas Liquid Chromatography,           PUY ...............   DMF ...............     Exemption is limited to test systems intended for employ-
                                                                        Barbiturate.                                                                        ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3150 .........   High Pressure Liquid Chro-           PUY ...............   KZY ................    Exemption is limited to test systems intended for employ-
                                                                         matography, Barbiturate.                                                           ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3170 .........   Enzyme Immunoassay,                  PUZ ...............   JXM ................    Exemption is limited to test systems intended for employ-
                                                                         Benzodiazepine.                                                                    ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3170 .........   High Pressure Liquid Chro-           PUZ ...............   LAA ................    Exemption is limited to test systems intended for employ-
                                                                         matography,                                                                        ment and insurance testing that include a statement in
                                                                         Benzodiazepine.                                                                    their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
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                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)




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                                                                                  Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                        31983

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                      Former
                                                                                                                   Exempt             product
                                                  21 CFR Section                 Device type                                                                                Partial exemption limitation
                                                                                                                product code           code
                                                                                                                                   (non-exempt)

                                                  862.3170 .........   Test, Benzodiazepine, Over           PUZ ...............   NFV ................     Exemption is limited to test systems intended for employ-
                                                                         The Counter.                                                                        ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3170 .........   Gas Chromatography,                  PUZ ...............   KZZ ................     Exemption is limited to test systems intended for employ-
                                                                        Benzodiazepine.                                                                      ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3170 .........   Thin Layer Chromatography,           PUZ ...............   LAB ................     Exemption is limited to test systems intended for employ-
                                                                         Benzodiazepine.                                                                     ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   Enzyme Immunoassay, Co-              PVA ...............   DIO .................    Exemption is limited to test systems intended for employ-
                                                                         caine and Cocaine Metabo-                                                           ment and insurance testing that include a statement in
                                                                         lites.                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   Radioimmunoassay, Cocaine            PVA ...............   KLN ................     Exemption is limited to test systems intended for employ-
                                                                        Metabolite.                                                                          ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   Enzyme Immunoassay, Co-              PVA ...............   JXO ................     Exemption is limited to test systems intended for employ-
                                                                         caine.                                                                              ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   Hemagglutination, Cocaine            PVA ...............   DLN ................     Exemption is limited to test systems intended for employ-
                                                                        Metabolites                                                                          ment and insurance testing that include a statement in
                                                                        (Benzoylecgonine).                                                                   their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   Thin Layer Chromatography,           PVA ...............   DMN ...............      Exemption is limited to test systems intended for employ-
                                                                         Cocaine.                                                                            ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)




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                                                  31984                           Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                      Former
                                                                                                                   Exempt             product
                                                  21 CFR Section                 Device type                                                                                Partial exemption limitation
                                                                                                                product code           code
                                                                                                                                   (non-exempt)

                                                  862.3250 .........   Free Radical Assay, Cocaine          PVA ...............   DIR .................    Exemption is limited to test systems intended for employ-
                                                                                                                                                             ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   Gas Chromatography, Co-              PVA ...............   DIN .................    Exemption is limited to test systems intended for employ-
                                                                        caine.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   Thin Layer Chromatography,           PVA ...............   DOM ...............      Exemption is limited to test systems intended for employ-
                                                                         Benzoylecgonine.                                                                    ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3250 .........   High Pressure Liquid Chro-           PVA ...............   LAC ................     Exemption is limited to test systems intended for employ-
                                                                         matography, Cocaine and                                                             ment and insurance testing that include a statement in
                                                                         Cocaine Metabolites.                                                                their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3270 .........   High Pressure Liquid Chro-           PVB ...............   LAE ................     Exemption is limited to test systems intended for employ-
                                                                         matography, Codeine.                                                                ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3270 .........   Thin Layer Chromatography,           PVB ...............   DLD ................     Exemption is limited to test systems intended for employ-
                                                                         Codeine.                                                                            ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3270 .........   Gas Chromatography, Co-              PVB ...............   LAD ................     Exemption is limited to test systems intended for employ-
                                                                        deine.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3580 .........   Radioimmunoassay, LSD                PVC ...............   DLB ................     Exemption is limited to test systems intended for employ-
                                                                        (125–I).                                                                             ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)




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                                                                                  Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                       31985

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                      Former
                                                                                                                   Exempt             product
                                                  21 CFR Section                 Device type                                                                               Partial exemption limitation
                                                                                                                product code           code
                                                                                                                                   (non-exempt)

                                                  862.3580 .........   Free Radical Assay, LSD ......       PVC ...............   DOL ................    Exemption is limited to test systems intended for employ-
                                                                                                                                                            ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3610 .........   Gas Chromatography, Meth-            PVD ...............   LAF ................    Exemption is limited to test systems intended for employ-
                                                                        amphetamine.                                                                        ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3610 .........   Thin Layer Chromatography,           PVD ...............   DJC ................    Exemption is limited to test systems intended for employ-
                                                                         Methamphetamine.                                                                   ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3610 .........   High Pressure Liquid Chro-           PVD ...............   LAG ................    Exemption is limited to test systems intended for employ-
                                                                         matography, Methamphet-                                                            ment and insurance testing that include a statement in
                                                                         amine.                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3610 .........   Test, Methamphetamine,               PVD ...............   NGG ...............     Exemption is limited to test systems intended for employ-
                                                                         Over The Counter.                                                                  ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3620 .........   Enzyme Immunoassay, Meth-            PVE ...............   DJR ................    Exemption is limited to test systems intended for employ-
                                                                         adone.                                                                             ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3620 .........   Hemagglutination Inhibition,         PVE ...............   DIW ................    Exemption is limited to test systems intended for employ-
                                                                        Methadone.                                                                          ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)
                                                  862.3620 .........   Gas Chromatography, Metha-           PVE ...............   DMB ...............     Exemption is limited to test systems intended for employ-
                                                                        done.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                            their labeling that the device is intended solely for use in
                                                                                                                                                            employment and insurance testing, and does not include
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                            test systems intended for Federal drug testing programs
                                                                                                                                                            (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                            Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                            ment of Transportation (DOT), and the U.S. military.)




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                                                  31986                           Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                       Former
                                                                                                                   Exempt              product
                                                  21 CFR Section                 Device type                                                                                 Partial exemption limitation
                                                                                                                product code            code
                                                                                                                                    (non-exempt)

                                                  862.3620 .........   Thin Layer Chromatography,           PVE ...............    DKR ...............      Exemption is limited to test systems intended for employ-
                                                                         Methadone.                                                                           ment and insurance testing that include a statement in
                                                                                                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                              employment and insurance testing, and does not include
                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)
                                                  862.3620 .........   Liquid Chromatography,               PVE ...............    DNT ................     Exemption is limited to test systems intended for employ-
                                                                         Methadone.                                                                           ment and insurance testing that include a statement in
                                                                                                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                              employment and insurance testing, and does not include
                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)
                                                  862.3620 .........   Free Radical Assay, Metha-           PVE ...............    DPP ................     Exemption is limited to test systems intended for employ-
                                                                         done.                                                                                ment and insurance testing that include a statement in
                                                                                                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                              employment and insurance testing, and does not include
                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)
                                                  862.3630 .........   Radioimmunoassay, Metha-             PVF ................   KXS ................     Exemption is limited to test systems intended for employ-
                                                                        qualone.                                                                              ment and insurance testing that include a statement in
                                                                                                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                              employment and insurance testing, and does not include
                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Thin Layer Chromatography,           PVG ...............    DNK ...............      Exemption is limited to test systems intended for employ-
                                                                         Morphine.                                                                            ment and insurance testing that include a statement in
                                                                                                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                              employment and insurance testing, and does not include
                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Radioimmunoassay, Mor-               PVG ...............    DOE ...............      Exemption is limited to test systems intended for employ-
                                                                        phine (123–I), Goat Anti-                                                             ment and insurance testing that include a statement in
                                                                        body Ammonium Sulfate                                                                 their labeling that the device is intended solely for use in
                                                                        Sep..                                                                                 employment and insurance testing, and does not include
                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Fluorometry, Morphine ..........     PVG ...............    DJJ .................    Exemption is limited to test systems intended for employ-
                                                                                                                                                              ment and insurance testing that include a statement in
                                                                                                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                              employment and insurance testing, and does not include
                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Liquid Chromatography, Mor-          PVG ...............    DPK ................     Exemption is limited to test systems intended for employ-
                                                                         phine.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                              their labeling that the device is intended solely for use in
                                                                                                                                                              employment and insurance testing, and does not include
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                              test systems intended for Federal drug testing programs
                                                                                                                                                              (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                              Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                              ment of Transportation (DOT), and the U.S. military.)




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                                                                                  Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                        31987

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                      Former
                                                                                                                   Exempt             product
                                                  21 CFR Section                 Device type                                                                                Partial exemption limitation
                                                                                                                product code           code
                                                                                                                                   (non-exempt)

                                                  862.3640 .........   Gas Chromatography, Mor-             PVG ...............   DMY ...............      Exemption is limited to test systems intended for employ-
                                                                        phine.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Hemagglutination Inhibition,         PVG ...............   DLR ................     Exemption is limited to test systems intended for employ-
                                                                        Morphine.                                                                            ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Free Radical Assay, Mor-             PVG ...............   DOK ...............      Exemption is limited to test systems intended for employ-
                                                                         phine.                                                                              ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Radioimmunoassay, Mor-               PVG ...............   DIQ .................    Exemption is limited to test systems intended for employ-
                                                                        phine (3–H), Goat Antibody                                                           ment and insurance testing that include a statement in
                                                                        Ammonium Sulfate Sep..                                                               their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3640 .........   Radioimmunoassay, Mor-               PVG ...............   DNA ...............      Exemption is limited to test systems intended for employ-
                                                                        phine-Barbiturate (125–I),                                                           ment and insurance testing that include a statement in
                                                                        Goat Antibody.                                                                       their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3650 .........   Enzyme Immunoassay, Opi-             PVH ...............   DJG ................     Exemption is limited to test systems intended for employ-
                                                                         ates.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3650 .........   Gas Chromatography, Opi-             PVH ...............   DJF ................     Exemption is limited to test systems intended for employ-
                                                                        ates.                                                                                ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)
                                                  862.3650 .........   Hemagglutination, Opiates ....       PVH ...............   DLT ................     Exemption is limited to test systems intended for employ-
                                                                                                                                                             ment and insurance testing that include a statement in
                                                                                                                                                             their labeling that the device is intended solely for use in
                                                                                                                                                             employment and insurance testing, and does not include
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                             test systems intended for Federal drug testing programs
                                                                                                                                                             (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                             Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                             ment of Transportation (DOT), and the U.S. military.)




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                                                  31988                           Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                        Former
                                                                                                                   Exempt               product
                                                  21 CFR Section                 Device type                                                                                   Partial exemption limitation
                                                                                                                product code             code
                                                                                                                                     (non-exempt)

                                                  862.3650 .........   Thin Layer Chromatography,           PVH ...............     LAI ..................    Exemption is limited to test systems intended for employ-
                                                                         Opiates.                                                                               ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3650 .........   Free Radical Assay, Opiates          PVH ...............     DKT ................      Exemption is limited to test systems intended for employ-
                                                                                                                                                                ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3650 .........   High Pressure Liquid Chro-           PVH ...............     LAH ................      Exemption is limited to test systems intended for employ-
                                                                         matography, Opiates.                                                                   ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3700 .........   Enzyme Immunoassay,                  PVI .................   JXN ................      Exemption is limited to test systems intended for employ-
                                                                         Propoxyphene.                                                                          ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3700 .........   Thin Layer Chromatography,           PVI .................   DPN ...............       Exemption is limited to test systems intended for employ-
                                                                         Propoxyphene.                                                                          ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3700 .........   Gas Chromatography,                  PVI .................   LAJ .................     Exemption is limited to test systems intended for employ-
                                                                        Propoxyphene.                                                                           ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3700 .........   High Pressure Liquid Chro-  PVI .................            LAK ................      Exemption is limited to test systems intended for employ-
                                                                         matography, Propoxyphene.                                                              ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3870 .........   Enzyme Immunoassay,                  PVJ ................    LDJ .................     Exemption is limited to test systems intended for employ-
                                                                         Cannabinoids.                                                                          ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)




                                             VerDate Sep<11>2014   18:01 Jul 10, 2017   Jkt 241001   PO 00000    Frm 00056    Fmt 4703     Sfmt 4703         E:\FR\FM\11JYN1.SGM   11JYN1


                                                                                  Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                           31989

                                                                                                         TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                        Former
                                                                                                                   Exempt               product
                                                  21 CFR Section                 Device type                                                                                   Partial exemption limitation
                                                                                                                product code             code
                                                                                                                                     (non-exempt)

                                                  862.3870 .........   Reagents, Test,                       PVJ ................   DKE ................      Exemption is limited to test systems intended for employ-
                                                                        Tetrahydrocannabinol.                                                                   ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3870 .........   Radioimmunoassay,                     PVJ ................   LAT ................      Exemption is limited to test systems intended for employ-
                                                                        Cannabinoid(S).                                                                         ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3910 .........   High Pressure Liquid Chro-            PVK ...............    LFI ..................    Exemption is limited to test systems intended for employ-
                                                                         matography, Tricyclic                                                                  ment and insurance testing that include a statement in
                                                                         Antidepressant Drugs.                                                                  their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3910 .........   U.V. Spectrometry, Tricyclic          PVK ...............    LFH ................      Exemption is limited to test systems intended for employ-
                                                                         Antidepressant Drugs.                                                                  ment and insurance testing that include a statement in
                                                                                                                                                                their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  862.3910 .........   Thin Layer Chromatography,            PVK ...............    MLK ................      Exemption is limited to test systems intended for employ-
                                                                         Tricyclic Antidepressant                                                               ment and insurance testing that include a statement in
                                                                         Drugs.                                                                                 their labeling that the device is intended solely for use in
                                                                                                                                                                employment and insurance testing, and does not include
                                                                                                                                                                test systems intended for Federal drug testing programs
                                                                                                                                                                (e.g., programs run by the Substance Abuse and Mental
                                                                                                                                                                Health Services Administration (SAMHSA), the Depart-
                                                                                                                                                                ment of Transportation (DOT), and the U.S. military.)
                                                  866.5750 .........   System, Test,                         PUW ..............     DHB ...............       Exemption is limited to devices classified under 21 CFR
                                                                         Radioallergosorbent                                                                    866.5750 that are intended to detect any of the allergens
                                                                         (RAST) Immunological.                                                                  included in table 3 of this document.
                                                  868.2385 .........   Analyzer, Nitrogen Dioxide ....       PUG ...............    MRQ ...............       Exemption is limited to standalone nitrogen dioxide ana-
                                                                                                                                                                lyzers and not those that are components of nitric oxide
                                                                                                                                                                delivery systems intended to monitor nitrogen dioxide
                                                                                                                                                                levels during inhaled nitric oxide therapy.
                                                  870.1330 .........   Wire, Guide, Catheter ...........     PTL ................   DQX ...............       Exemption is limited to accessory torque devices that are
                                                                                                                                                                manually operated, non-patient contacting, and intended
                                                                                                                                                                to manipulate non-cerebral vascular guide wires.
                                                  870.1650 .........   Syringe, Balloon Inflation ......     PTM ...............    MAV ...............       Exemption is limited to non-patient contacting balloon infla-
                                                                                                                                                                tion syringes intended only to inflate/deflate balloon cath-
                                                                                                                                                                eters and monitor pressure within the balloon.
                                                  870.2770 .........   Analyzer, Body Composition            PUH ...............    MNW ..............        Exemption is limited to body composition analyzers which
                                                                                                                                                                are not intended to diagnose or treat any medical condi-
                                                                                                                                                                tion.
                                                  870.4400 .........   Reservoir, Blood,                     PTN ...............    DTN ................      Exemption is limited to cardiopulmonary bypass blood res-
                                                                         Cardiopulmonary Bypass.                                                                ervoirs that do not contain defoamers or blood filters.
                                                  874.1090 .........   Tester, Auditory Impedance ..         PTO ...............    ETY ................      Exemption is limited to auditory impedance testers that are
                                                                                                                                                                in compliance with FDA-recognized consensus standard
mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                                ANSI S3.39.
                                                  874.1090 .........   Tympanometer ......................   PTP ................   NAS ................      Exemption is limited to tympanometers that are in compli-
                                                                                                                                                                ance with FDA-recognized consensus standard ANSI
                                                                                                                                                                S3.39.
                                                  876.1500 .........   Endoscopic Magnetic Re-               PTQ ...............    FCC ................      Exemption is limited to endoscopic magnetic retrievers in-
                                                                         triever.                                                                               tended for single use.
                                                  876.1500 .........   Scissors For Cystoscope ......        PTR ...............    KGD ...............       Exemption is limited to sterile scissors for cystoscope in-
                                                                                                                                                                tended for single use.



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                                                  31990                                     Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                        TABLE 2—CLASS II DEVICES—Continued
                                                                                                                                                        Former
                                                                                                                                Exempt                  product
                                                  21 CFR Section                           Device type                                                                                        Partial exemption limitation
                                                                                                                             product code                code
                                                                                                                                                     (non-exempt)

                                                  876.1500 .........          Endoscopic Grasping/Cutting                   PTS ................    OCZ ...............      Exemption is limited to disposable, non-powered
                                                                                Instrument, Non-Powered.                                                                       endoscopic grasping/cutting instruments intended for sin-
                                                                                                                                                                               gle use.
                                                  876.5010 .........          Catheter, Biliary, Surgical ......            PTT ................    GCA ...............      Exemption is limited to surgical biliary catheters that do not
                                                                                                                                                                               include a balloon component.
                                                  876.5630 .........          Catheter, Peritoneal, Long-                   PTU ...............     FJS .................    Exemption is limited to non-patient contacting catheter fin-
                                                                                Term Indwelling.                                                                               ger grips intended for single use.
                                                  876.5630 .........          Catheter, Peritoneal Dialysis,                PTV ................    FKO ................     Exemption is limited to non-patient contacting catheter fin-
                                                                                Single Use.                                                                                    ger grips intended for single use.
                                                  876.5630 .........          System, Peritoneal, Auto-                     PTW ...............     FKX ................     Exemption is limited to continuous ambulatory peritoneal di-
                                                                                matic Delivery.                                                                                alysis (CAPD) belts and catheter stands that do not in-
                                                                                                                                                                               clude weigh scales.
                                                  878.4370 .........          Drape, Surgical ......................        PUI .................   KKX ................     Exemption is limited to surgical drapes that do not include
                                                                                                                                                                               an antimicrobial agent.
                                                  878.4495 .........          Suture, Nonabsorbable,                        PTX ................    GAQ ...............      Exemption is limited to steel monofilament sutures that are
                                                                                Steel, Monofilament And                                                                        uncoated and do not incorporate barbs.
                                                                                Multifilament, Sterile.
                                                  882.1470 .........          Computerized Cognitive As-                    PTY ................    PKQ ...............      Exemption is limited to computerized cognitive assessment
                                                                                sessment Aid.                                                                                  aids that are not intended for diagnostic assessment of
                                                                                                                                                                               specific diseases or conditions and rely on inputs from
                                                                                                                                                                               visual cues, auditory cues, and/or functional use of the
                                                                                                                                                                               hand.
                                                  884.1630 .........          Colposcope (and                               PTZ ................    HEX ................     Exemption is limited to standard colposcopes (and
                                                                               Colpomicroscope).                                                                               colpomicroscopes) that use only a white light source, do
                                                                                                                                                                               not use filters other than a green filter, do not include
                                                                                                                                                                               image analysis software, and are not smartphone-based.
                                                  884.4530 .........          Tenaculum, Uterine ...............            PUA ...............     HDC ...............      Exemption is limited to sterile uterine tenaculum devices
                                                                                                                                                                               that do not use suction and are intended for single use.
                                                  884.6120 .........          Accessory, Assisted Repro-                    PUB ...............     MQG ..............       Exemption is limited to simple embryo incubators with tem-
                                                                                duction.                                                                                       perature, gas, and humidity control only; syringe pumps;
                                                                                                                                                                               collection tube warmers; dish/plate/microscope stage
                                                                                                                                                                               warmers; and controlled-rate cryopreservation freezers.
                                                  884.6130 .........          Microtools, Assisted Repro-                   PUC ...............     MQH ...............      Exemption is limited to assisted reproduction microtools (pi-
                                                                                duction (Pipettes).                                                                            pettes) manufactured from glass.
                                                  884.6160 .........          Labware, Assisted Reproduc-                   PUD ...............     MQK ...............      Exemption is limited to dishes and plates that are intended
                                                                                tion.                                                                                          for general assisted reproduction technology procedures.
                                                  886.1850 .........          Biomicroscope, Slit-Lamp,                     PUE ...............     HJO ................     Exemption is limited to slit-lamp, AC-powered biomicro-
                                                                                AC-Powered.                                                                                    scopes intended only for the visual examination of the
                                                                                                                                                                               anterior segment of the eye, are classified as Group 1
                                                                                                                                                                               per FDA-recognized consensus standard ANSI Z80.36,
                                                                                                                                                                               do not provide any quantitative output, and are not in-
                                                                                                                                                                               tended for screening or automated diagnostic indications.
                                                  886.3320 .........          Ocular Peg ............................       PUF ...............     MQU ...............      Exemption is limited to ocular pegs supplied sterile.



                                                    In table 2, FDA included devices                                      exemption criteria from premarket                               to the general limitations to the
                                                  classified under § 866.5750                                             notification requirements. The devices                          exemptions found in § 866.9. While the
                                                  (Radioallergosorbent (RAST)                                             listed in table 3 are also classified under                     non-exempt devices classified under
                                                  immunological test system). FDA does                                    § 866.5750, but this subset no longer                           § 866.5750 will retain product code
                                                  not believe that all devices classified                                 requires premarket notification under                           ‘‘DHB’’, these devices listed in table 3
                                                  under this regulation meet the                                          section 510(k) of the FD&C Act, subject                         are reassigned product code ‘‘PUW.’’

                                                                                                                         TABLE 3—CLASS II DEVICES
                                                                                                        [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                        Source
                                                   Allergen code                                               Allergen product                                                                   (taxonomical name)

                                                                                                                                                Grass Pollens
mstockstill on DSK30JT082PROD with NOTICES




                                                  g1   ....................   Sweet vernal grass ....................................................................    Anthoxanthum odoratum.
                                                  g3   ....................   Cocksfoot grass, Orchard grass ................................................            Dactylis glomerata.
                                                  g4   ....................   Meadow fescue ..........................................................................   Festuca elatior.
                                                  g5   ....................   Rye-grass (perennial rye grass) ................................................           Lolium perenne.
                                                  g7   ....................   Common reed (common reed grass) ........................................                   Phragmites communis.
                                                  g8   ....................   Meadow grass, Kentucky blue (June grass) .............................                     Poa pratensis.



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                                                                                            Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                          31991

                                                                                                                     TABLE 3—CLASS II DEVICES—Continued
                                                                                                          [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                             Source
                                                   Allergen code                                                Allergen product                                                                       (taxonomical name)

                                                  g9 ....................    Redtop, Bentgrass .....................................................................             Agrostis stolonifera
                                                                                                                                                                                 Agrostis gigantea (Agrostis alba).
                                                  g11   ..................   Brome grass ...............................................................................         Bromus inermis.
                                                  g12   ..................   Cultivated rye (cultivated rye grass) ..........................................                    Secale cereale.
                                                  g13   ..................   Velvet grass ...............................................................................        Holcus lanatus.
                                                  g14   ..................   Cultivated oat (cultivated oat grass) ..........................................                    Avena sativa.
                                                  g15   ..................   Cultivated wheat (cultivated wheat grass) .................................                         Triticum aestivum
                                                                                                                                                                                 (Triticum spp.).
                                                  g16 ..................     Meadow foxtail (meadow foxtail grass) .....................................                         Alopecurus pratensis.
                                                  g17 ..................     Bahia grass ................................................................................        Paspalum notatum.
                                                  g24 ..................     Wheat grass, Western ...............................................................                Agropyron smithii
                                                                                                                                                                                 (Elymus smithii).
                                                  g30 ..................     Bluegrass, annual ......................................................................            Poa annua.
                                                  g70 ..................     Wild rye grass ............................................................................         Elymus triticoides
                                                                                                                                                                                 Elymus condensatus.
                                                  g71 ..................     Canary grass ..............................................................................         Phalaris arundinacea.
                                                  g201 ................      Barley, cultivated ........................................................................         Hordeum vulgare.
                                                  g202 ................      Maize, corn (cultivated corn) .....................................................                 Zea mays.
                                                  g203 ................      Salt grass ...................................................................................      Distichlis spicata.
                                                  g204 ................      False oat-grass ..........................................................................          Arrhenatherum elatius.
                                                  g216 ................      Cyn d 1 ......................................................................................      Cynodon dactylon.
                                                  g701 ................      Phl p 1.0102, Phl p 5.0101 ........................................................                 Phleum pratense.
                                                  g702 ................      Phl p 7.0101 ...............................................................................        Phleum pratense.
                                                  g703 ................      Phl p 12.0101 .............................................................................         Phleum pratense.

                                                                                                                                                      Weed Pollens

                                                  w2 ...................     Western ragweed .......................................................................             Ambrosia psilostachya.
                                                  w4 ...................     False ragweed ...........................................................................           Ambrosia acanthicarpa
                                                                                                                                                                                 (Franseria acanthicarpa).
                                                  w5 ...................     Wormwood .................................................................................          Artemisia absinthium
                                                                                                                                                                                 Artemisia annua.
                                                  w6 ...................     Mugwort .....................................................................................       Artemisia vulgaris.
                                                  w7 ...................     Marguerite, ox-eye daisy ...........................................................                Chrysanthemum leucanthemum.
                                                  w8 ...................     Dandelion ...................................................................................       Taraxacum vulgare
                                                                                                                                                                                 Taraxacum officinale.
                                                  w9 ...................     Plantain (English), Ribwort ........................................................                Plantago lanceolata.
                                                  w10 .................      Goosefoot, lamb’s quarters ........................................................                 Chenopodium album.
                                                  w11 .................      Saltwort (prickly), Russian thistle ...............................................                 Salsola kali
                                                                                                                                                                                 (Salsola pestifer).
                                                  w12 .................      Goldenrod ..................................................................................        Solidago virgaurea
                                                                                                                                                                                 (Solidago spp.)
                                                  w13    .................   Cocklebur, common ...................................................................               Xanthium commune.
                                                  w14    .................   Common pigweed (rough pigweed) ...........................................                          Amaranthus retroflexus.
                                                  w15    .................   Scale, Lenscale ..........................................................................          Atriplex lentiformis.
                                                  w16    .................   Rough marsh elder ....................................................................              Iva ciliate
                                                                                                                                                                                 Iva annua.
                                                  w17    .................   Firebush (Kochia) .......................................................................           Kochia scoparia.
                                                  w18    .................   Sheep sorrel ...............................................................................        Rumex acetosella.
                                                  w19    .................   Wall pellitory ...............................................................................      Parietaria officinalis.
                                                  w20    .................   Nettle (Common stinging nettle) ................................................                    Urtica dioica.
                                                  w21    .................   Wall pellitory ...............................................................................      Parietaria judaica.
                                                  w22    .................   Japanese hop (careless weed) ..................................................                     Humulus japonicas
                                                                                                                                                                                 (Humulus scandens).
                                                  w23    .................   Yellow dock, Yellow dockweed ..................................................                     Rumex crispus.
                                                  w24    .................   Spiny pigweed ............................................................................          Amaranthus spinosus.
                                                  w27    .................   Carnation ....................................................................................      Dianthus spp.
                                                  w28    .................   Rose ...........................................................................................    Rosa rugosa.
                                                  w33    .................   Clover .........................................................................................    Trifolium pratense.
                                                  w35    .................   Mexican tea ................................................................................        Chenopodium ambrosioides.
                                                  w36    .................   Rabbit bush ................................................................................        Ambrosia deltoidea
                                                                                                                                                                                 (Franseria deltoides).
mstockstill on DSK30JT082PROD with NOTICES




                                                  w37 .................      Salt bush, annual .......................................................................           Atriplex wrightii.
                                                  w39 .................      Water hemp, Western ................................................................                Amaranthus rudis
                                                                                                                                                                                 (Acnida tamariscina).
                                                  w41    .................   Burrobrush .................................................................................        Hymenoclea salsola.
                                                  w42    .................   Poverty weed.
                                                  w43    .................   Common sagebrush ...................................................................                Artemisia tridentata.
                                                  w45    .................   Alfalfa .........................................................................................   Medicago sativa.
                                                  w46    .................   Dog fennel ..................................................................................       Eupatorium capillifolium.



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                                                  31992                                      Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                      TABLE 3—CLASS II DEVICES—Continued
                                                                                                           [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                              Source
                                                   Allergen code                                                 Allergen product                                                                       (taxonomical name)

                                                  w53     .................   Geranium ...................................................................................        Geranium spp.
                                                  w67     .................   Groundsel bush ..........................................................................           Baccharis halimifolia.
                                                  w69     .................   Iodine bush ................................................................................        Allenrolfea occidentalis.
                                                  w70     .................   Ragweed, slender ......................................................................             Ambrosia confertiflora.
                                                  w75     .................   Wing scale (wingscale) ..............................................................               Atriplex canescens.
                                                  w82     .................   Careless weed ...........................................................................           Amaranthus palmeri
                                                                                                                                                                                  Amaranthus hybridus.
                                                  w90 .................       Japanese hop ............................................................................           Humulus japonicas
                                                                                                                                                                                  (Humulus scandens).
                                                  w203 ...............        Rape (rape pollen) .....................................................................            Brassica napus.
                                                  w204 ...............        Sunflower ...................................................................................       Helianthus annuus.
                                                  w206 ...............        Camomile ...................................................................................        Matricaria chamomilla.
                                                  w207 ...............        Lupin ..........................................................................................    Lupinus spp.
                                                  w210 ...............        Sugar-beet .................................................................................        Beta vulgaris.
                                                  w211 ...............        Par j 2.0101 ...............................................................................        Parietaria judaica.
                                                  w231 ...............        Art v 1 ........................................................................................    Artemisia vulgaris (Mugwort).
                                                  w232 ...............        Sal k 1 ........................................................................................    Salsola kali.
                                                  w233 ...............        Art v 3 ........................................................................................    Artemisa vulgaris (LTP, Mugwort).
                                                  w234 ...............        Pla l 1 .........................................................................................   Plantago lanceolata.
                                                  w235 ...............        Che a 1.0101 .............................................................................          Chenopodium album.
                                                  w236 ...............        Mer a 1.0101 ..............................................................................         Mercurialis annua.
                                                  a753 ................       Art v 1 ........................................................................................    Artemisia vulgaris (Mugwort weed).

                                                                                                                                                        Tree Pollens

                                                  t1 .....................    Box-elder (Maple) ......................................................................            Acer negundo.
                                                                                                                                                                                  Acer saccharum.
                                                  t2 .....................    Gray alder, speckled alder (alder) .............................................                    Alnus incana.
                                                  t4 .....................    Hazel, hazelnut ..........................................................................          Corylus avellana.
                                                                                                                                                                                  Corylus americana.
                                                  t5 .....................    American beech (beech) ............................................................                 Fagus grandifolia.
                                                                                                                                                                                  (Fagus americana).
                                                  t6 .....................    Mountain juniper, Mountain cedar .............................................                      Juniperus ashei
                                                                                                                                                                                  (Juniperus sabinoides).
                                                  t8 .....................    Elm .............................................................................................   Ulmus americana.
                                                  t9 .....................    Olive ...........................................................................................   Olea europaea.
                                                  t10 ...................     Walnut ........................................................................................     Juglans californica
                                                                                                                                                                                  Juglans nigra.
                                                  t11 ...................     Maple leaf sycamore, London plane, Plane tree .......................                               Platanus acerifolia.
                                                  t61 ...................     Sycamore ...................................................................................        Platanus occidentalis.
                                                  t12 ...................     Willow .........................................................................................    Salix caprea
                                                                                                                                                                                  Salix nigra.
                                                  t14   ...................   Cottonwood (Eastern Cottonwood/Black Cottonwood) .............                                      Populus deltoides.
                                                  t15   ...................   White ash ...................................................................................       Fraxinus americana.
                                                  t16   ...................   White pine ..................................................................................       Pinus strobus.
                                                  t18   ...................   Eucalyptus, gum-tree .................................................................              Eucalyptus globulus.
                                                                                                                                                                                  (Eucalyptus spp.).
                                                  t19/t26 .............       Acacia ........................................................................................     Acacia longifolia (Acacia spp.).
                                                  t20 ...................     Mesquite .....................................................................................      Prosopis glandulosa/
                                                                                                                                                                                  Prosopis juliflora.
                                                  t21 ...................     Melaleuca, cajeput tree ..............................................................              Melaleuca quinquenervia (Melaleuca leucadendron).
                                                  t22 ...................     Pecan, hickory ...........................................................................          Carya illinoinensis
                                                                                                                                                                                  (Carya pecan).
                                                  t23   ...................   Italian/Mediterranean/funeral cypress ........................................                      Cupressus sempervirens.
                                                  t24   ...................   Japanese cypress ......................................................................             Chamaecyparis obtusa (Chamaecyparis spp.).
                                                  t25   ...................   Ash .............................................................................................   Fraxinus excelsior.
                                                  t27   ...................   Maple, red ..................................................................................       Acer rubrum.
                                                  t29   ...................   Acacia ........................................................................................     Acacia spp.
                                                  t30   ...................   Birch, white ................................................................................       Betula populifolia.
                                                  t32   ...................   Willow, black ..............................................................................        Salix nigra.
                                                  t33   ...................   Ash, Arizona ...............................................................................        Fraxinus velutina.
                                                  t35   ...................   Cedar, salt ..................................................................................      Tamarix gallica.
mstockstill on DSK30JT082PROD with NOTICES




                                                  t37   ...................   Bald cypress (white bald cypress) .............................................                     Taxodium distichum.
                                                  t38   ...................   Elm, Chinese/Siberian ...............................................................               Ulmus pumila.
                                                  t40   ...................   Hazelnut tree ..............................................................................        Corylus americana.
                                                  t41   ...................   White hickory .............................................................................         Carya alba
                                                                                                                                                                                  (Carya tomentosa).
                                                  t42 ...................     Oak, red .....................................................................................      Quercus rubra.
                                                  t43 ...................     Loblolly pine ...............................................................................       Pinus taeda.
                                                  t44 ...................     Hackberry ...................................................................................       Celtis occidentalis.



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                                                                                            Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                                 31993

                                                                                                                     TABLE 3—CLASS II DEVICES—Continued
                                                                                                          [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                              Source
                                                   Allergen code                                                 Allergen product                                                                       (taxonomical name)

                                                  t45 ...................    Cedar elm ..................................................................................         Ulmus crassifolia.
                                                  t47 ...................    Juniper, one seed ......................................................................             Juniperus monosperma.
                                                  t48 ...................    Pine, lodgepole ..........................................................................           Pinus contorta.
                                                  t49 ...................    Pine, ponderosa .........................................................................            Pinus ponderosa.
                                                  t50 ...................    Beech, European .......................................................................              Fagus sylvatica.
                                                  t51 ...................    Tree of Heaven ..........................................................................            Ailanthus altissima.
                                                  t52 ...................    Western white pine ....................................................................              Pinus monticola.
                                                  t54 ...................    Russian olive ..............................................................................         Elaeagnus angustifolia.
                                                  t55 ...................    Scotch broom .............................................................................           Cytisus scoparius.
                                                  t56 ...................    Bayberry .....................................................................................       Myrica cerifera.
                                                  t57 ...................    Red cedar ..................................................................................         Juniperus virginiana.
                                                  t60 ...................    Western juniper ..........................................................................           Juniperus occidentalis.
                                                  t61 ...................    Sycamore ...................................................................................         Platanus occidentalis.
                                                  t70 ...................    Mulberry (white mulberry) ..........................................................                 Morus alba.
                                                  t71 ...................    Red mulberry .............................................................................           Morus rubra.
                                                  t72 ...................    Queen palm ...............................................................................           Arecastrum romanzoffiamon.
                                                  t73 ...................    Australian pine ...........................................................................          Casuarina equisetifolia.
                                                  t77 ...................    Oak mix (red, white, black) ........................................................                 Quercus spp.
                                                  t80 ...................    Japanese cypress ......................................................................              Chamaecyparis obtusa.
                                                  t81 ...................    Japanese alder ..........................................................................            Alnus japonica.
                                                  t83 ...................    Mango tree .................................................................................         Mangifera indica.
                                                  t90 ...................    Walnut, black .............................................................................          Juglans nigra.
                                                  t96 ...................    Poplar, white (poplar) .................................................................             Populus alba.
                                                  t103/ ................     Virginia live oak (live oak) ..........................................................              Quercus virginiana.
                                                  t218 .................
                                                  t105 .................     Pepper tree ................................................................................         Schinus molle.
                                                  t110 .................     Orange tree ................................................................................         Citrus sinensis.
                                                  t201 .................     Spruce, Norway spruce .............................................................                  Picea abies (Picea excelsa).
                                                  t202 .................     Alder, smooth .............................................................................          Alnus incana spp. Rugosa
                                                                                                                                                                                  (Alnus rugosa).
                                                  t203   .................   Horse chestnut ...........................................................................           Aesculus hippocastanum.
                                                  t205   .................   Elder ...........................................................................................    Sambucus nigra.
                                                  t206   .................   Chestnut .....................................................................................       Castanea sativa.
                                                  t207   .................   Douglas fir ..................................................................................       Pseudotsuga menziesii (Pseudotsuga taxifolia).
                                                  t208   .................   Linden ........................................................................................      Tilia cordata.
                                                  t209   .................   Horn beam .................................................................................          Carpinus betulus.
                                                  t210   .................   Privet ..........................................................................................    Ligustrum vulgare.
                                                  t211   .................   Sweet gum .................................................................................          Liquidambar styraciflua.
                                                  t212   .................   Cedar .........................................................................................      Libocedrus decurrens.
                                                  t213   .................   Pine ............................................................................................    Pinus radiata.
                                                  t214   .................   Date palm ...................................................................................        Phoenix canariensis.
                                                  t215   .................   Lilac ............................................................................................   Syringa vulgaris.
                                                  t217   .................   Pepper tree ................................................................................         Schinus molle.
                                                  t217   .................   Red alder ...................................................................................        Alnus rubra.
                                                  t218   .................   Virginia live oak ..........................................................................         Quercus virginiana.
                                                  t218   .................   Bayberry (bayberry/sweet gale) .................................................                     Myrica gale.
                                                  t219   .................   Palo verde ..................................................................................        Cercidium floridum.
                                                  t219   .................   Red cedar ..................................................................................         Juniperus virginiana.
                                                  t220   .................   Bet v 4 ........................................................................................     Betula verrucosa (Birch).
                                                  t221   .................   Bet v 2.0101, Bet v 4 .................................................................              Betula verrucosa (Birch).
                                                  t222   .................   Cypress (Arizona cypress) .........................................................                  Cupressus arizonica.
                                                  t223   .................   Oil palm ......................................................................................      Elaeis guineensis.
                                                  t224   .................   Ole e 1 .......................................................................................      Olea europaea.
                                                  t225   .................   Bet v 6 ........................................................................................     Betula verrucosa (Birch).
                                                  t226   .................   Cup a 1 ......................................................................................       Cupressus arizonica.
                                                  t227   .................   Ole e 7 .......................................................................................      Olea Europaea.
                                                  t228   .................   Aspen, quaking ..........................................................................            Populus tremuloides.
                                                  t229   .................   Eastern hemlock ........................................................................             Tsuga canadensis.
                                                  t230   .................   Redwood (sequoia) ....................................................................               Sequoia sempervirens.
                                                  t232   .................   Pussy willow ...............................................................................         Salix discolor.
                                                  t240   .................   Ole e 9.0101 ..............................................................................          Olea Europaea.
                                                  t241   .................   Pla a 1.0101 ...............................................................................         Platanus acerifolia.
mstockstill on DSK30JT082PROD with NOTICES




                                                  t242   .................   Pla a 2 ........................................................................................     Platanus acerifolia.
                                                  t243   .................   Pla a 3.0101 ...............................................................................         Platanus acerifolia.
                                                  t244   .................   Cor a 1.0103 ..............................................................................          Corylus avellana.
                                                  t245   .................   Aln g 1.0101 ...............................................................................         Alnus glutinosa.
                                                  t246   .................   Cry j 1 ........................................................................................     Cryptomeria japonica.
                                                  t280   .................   Locust tree .................................................................................        Robinia pseudoacacia.
                                                  t401   .................   Brazilian peppertree ...................................................................             Schinus terebinthifolius.
                                                  t402   .................   Mastic tree .................................................................................        Pistacia lentiscus.



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                                                  31994                                     Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                    TABLE 3—CLASS II DEVICES—Continued
                                                                                                         [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                           Source
                                                   Allergen code                                                Allergen product                                                                     (taxonomical name)

                                                  t404 .................     Tree of heaven ...........................................................................        Ailanthus altissima.
                                                  t406 .................     Date palm ...................................................................................     Phoenix dactylifera.
                                                  a482 ................      Ole e 1 .......................................................................................   Olea europaea (Olive Oil).

                                                                                                                                                           Mites

                                                  d207 ................      Blo t 5.0101 ................................................................................     Blomia tropicalis.
                                                  d208 ................      Lep d 2.0101 ..............................................................................       Lepidoglyphus destructor.

                                                                                                                                       Microorganisms, Molds, Yeast

                                                  m1 ...................     Penicillium chrysogenum ...........................................................               Penicillium chrysogenum (Penicillium notatum).
                                                                             (Penicillium notatum)
                                                  m2   ...................   Cladosporium herbarum (Hormodendrum) ................................                             Cladosporium herbarum (Hormodendrum).
                                                  m3   ...................   Aspergillus fumigatus .................................................................           Aspergillus fumigatus.
                                                  m4   ...................   Mucor racemosus ......................................................................            Mucor racemosus.
                                                  m5   ...................   Candida albicans .......................................................................          Candida albicans.
                                                  m7   ...................   Botrytis cinerea ..........................................................................       Botrytis cinerea.
                                                  m8   ...................   Drechslera        halodes               (Setomelanomma                        rostrata,           Drechslera halodes
                                                                               Helminthosporium                  halodes,                  Helminthosporium                    (Setomelanomma rostrata, Helminthosporium halodes).
                                                                               interseminatum).
                                                  m9 ...................     Fusarium moniliforme (Fusarium proliferatum) ..........................                           Fusarium moniliforme
                                                                                                                                                                               (Fusarium proliferatum).
                                                  m10 .................      Stemphylium botryosum ............................................................                Stemphylium herbarum
                                                                                                                                                                               (Stemphylium botryosum).
                                                  m11    .................   Rhizopus nigricans .....................................................................          Rhizopus nigricans.
                                                  m12    .................   Aureobasidium pullulans ............................................................              Aureobasidium pullulans.
                                                  m13    .................   Phoma betae ..............................................................................        Phoma betae.
                                                  m14    .................   Epicoccum purpurascens ...........................................................                Epicoccum purpurascens
                                                                                                                                                                               (Epicoccum nigrum).
                                                  m15 .................      Trichoderma viride .....................................................................          Trichoderma viride.
                                                  m16 .................      Curvularia lunata ........................................................................        Curvularia lunata
                                                                                                                                                                               Curvularia specifera (K923044).
                                                  m17    .................   Cladosporium fulvum .................................................................             Cladosporium fulvum.
                                                  m18    .................   Fusarium culmorum ...................................................................             Fusarium culmorum.
                                                  m19    .................   Aspergillus versicolor .................................................................          Aspergillus versicolor.
                                                  m20    .................   Mucor mucedo ...........................................................................          Mucor mucedo.
                                                  m21    .................   Aspergillus clavatus ...................................................................          Aspergillus clavatus.
                                                  m22    .................   Micropolyspora faeni ..................................................................           Saccharopolyspora rectivirgula (Micropolyspora faeni).
                                                  m23    .................   Thermoactinomyces vulgaris .....................................................                  Thermoactinomyces vulgaris.
                                                  m24    .................   Stachybotrys atra .......................................................................         Stachybotrys chartarum (Stachybotrys atra).
                                                  m24    .................   Paecilomyces spp. .....................................................................           Paecilomyces spp.
                                                  m25    .................   Aspergillus versicolor .................................................................          Aspergillus versicolor.
                                                  m25    .................   Penicillium brevicompactum ......................................................                 Penicillium brevicompactum.
                                                  m26    .................   Cladosporium cladosporioides ...................................................                  Cladosporium cladosporioides.
                                                  m26    .................   Penicillium citrinum ....................................................................         Penicillium citrinum.
                                                  m27    .................   Penicillium spp. ..........................................................................       Penicillium spp.
                                                  m29    .................   Aspergillus repens .....................................................................          Aspergillus repens.
                                                  m30    .................   Penicillium roqueforti ..................................................................         Penicillium roqueforti.
                                                  m32    .................   Cladosporium cladosporioides ...................................................                  Cladosporium cladosporioides.
                                                  m34    .................   Serpula lacrymans .....................................................................           Serpula lacrymans.
                                                  m36    .................   Aspergillus terreus .....................................................................         Aspergillus terreus.
                                                  m37    .................   Trichophyton mentagrophytes ...................................................                   Trichophyton mentagrophytes.
                                                  m40    .................   Aspergillus amstelodami ............................................................              Aspergillus amstelodami.
                                                  m43    .................   Saccharomyces carlsberg ..........................................................                Saccharomyces carlsbergensis.
                                                  m44    .................   Saccharomyces cerevisiae ........................................................                 Saccharomyces cerevisiae.
                                                  m45    .................   Hormodendrum hordei ...............................................................               Hormodendrum hordei.
                                                  m46    .................   Bipolaris spicifera .......................................................................       Bipolaris spicifera.
                                                  m47    .................   Aspergillus nidulans ...................................................................          Aspergillus nidulans.
                                                  m48    .................   Aspergillus oryzae ......................................................................         Aspergillus oryzae.
                                                  m49    .................   Fusarium oxysporum .................................................................              Fusarium oxysporum.
                                                  m50    .................   Micropolyspora faeni ..................................................................           Saccharopolyspora rectivirgula (Micropolyspora faeni).
mstockstill on DSK30JT082PROD with NOTICES




                                                  m51    .................   Thermoactinomyces vulgaris .....................................................                  Thermoactinomyces vulgaris.
                                                  m53    .................   Microspora canis ........................................................................         Microsporum canis
                                                                                                                                                                               (Microspora canis).
                                                  m54    .................   Aspergillus flavus .......................................................................        Aspergillus flavus.
                                                  m63    .................   Helminthosporium intersemin ....................................................                  Helminthosporium intersemin.
                                                  m66    .................   Mucor plumbeus ........................................................................           Mucor plumbeus.
                                                  m67    .................   Mycogone ...................................................................................      Mycogone perniciosa.
                                                  m68    .................   Nigrospora oryzae ......................................................................          Nigrospora oryzae.



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                                                                                            Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                                   31995

                                                                                                                    TABLE 3—CLASS II DEVICES—Continued
                                                                                                         [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                            Source
                                                   Allergen code                                                Allergen product                                                                      (taxonomical name)

                                                  m69 .................      Rhodotorula ................................................................................       Rhodotorula rubra
                                                                                                                                                                                (Rhodotorula mucilaginosa).
                                                  m70 .................      Malassezia furfur (Pityrosporum orbiculare) ..............................                         Malassezia furfur
                                                                                                                                                                                (Pityrosporum orbiculare).
                                                  m71 .................      Spondylocladium ........................................................................           Spondylocladium spp.
                                                  m72 .................      Epidermophyton .........................................................................           Epidermophyton floccosum.
                                                  m73 .................      Epicoccum nigrum .....................................................................             Epicoccum purpurascens
                                                                                                                                                                                (Epicoccum nigrum).
                                                  m80 .................      Staphylococcal enterotoxin A (Sta a SEA) ................................                          Staphylococcus aureus.
                                                  m80 .................      Helminthosporium spp. ..............................................................               Helminthosporium spp.
                                                  m81 .................      Staphylococcal enterotoxin B (Sta a SEB) ................................                          Staphylococcus aureus.
                                                  m88 .................      Stemphylium solani ....................................................................            Stemphylium solani.
                                                  m93 .................      Gliocladium fimbriatum ..............................................................              Gliocladium fimbriatum.
                                                  m94 .................      Phycomyces blakesleeanus .......................................................                   Phycomyces blakesleeanus.
                                                  m201 ...............       Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut) ........                          Tilletia tritici
                                                                                                                                                                                (Ustilago nuda, Ustilago tritici).
                                                  m202     ...............   Acremonium kiliense (Cephalosporium acremonium) ...............                                    Acremonium kiliense (Cephalosporium acremonium).
                                                  m203     ...............   Trichosporon pullulans ...............................................................             Trichosporon pullulans.
                                                  m204     ...............   Ulocladium chartarum ................................................................              Ulocladium chartarum.
                                                  m205     ...............   Trichophyton rubrum ..................................................................             Trichophyton rubrum.
                                                  m207     ...............   Aspergillus niger ........................................................................         Aspergillus niger.
                                                  m208     ...............   Chaetomium globosum ..............................................................                 Chaetomium globosum.
                                                  m209     ...............   Penicillium frequentans ..............................................................             Penicillium glabrum
                                                                                                                                                                                (Penicillium frequentans).
                                                  m209 ...............       Stachybotrys chartarum .............................................................               Stachybotrys chartarum (Stachybotrys atra).
                                                  m210 ...............       Trichophyton mentagrophytes var. goetzii .................................                         Trichophyton mentagrophytes var. goetzii.
                                                  m211 ...............       Trichophyton mentagrophytes var. interdigitale .........................                           Trichophyton mentagrophytes var. interdigitale.
                                                  m211 ...............       Oat smut ....................................................................................      Ustilago avenae.
                                                  m212 ...............       Micropolyspora faeni ..................................................................            Saccharopolyspora rectivirgula (Micropolyspora faeni).
                                                  m212 ...............       Geotrichum candidum ................................................................               Geotrichum candidum.
                                                  m213 ...............       Bermuda grass smut ..................................................................              Ustilago cynodontis.
                                                  m214 ...............       Johnson grass smut ...................................................................             Sphacelotheca cruenta.
                                                  m215 ...............       Corn smut ..................................................................................       Ustilago maydis.
                                                  m218 ...............       Asp f 1.0101 ...............................................................................       Aspergillus fumigatus.
                                                  a3050 ..............       Asp r 1 .......................................................................................    Aspergillus restrictus.
                                                  m219 ...............       Asp f 2 ........................................................................................   Aspergillus fumigatus.
                                                  m220 ...............       Asp f 3.0101 ...............................................................................       Aspergillus fumigatus.
                                                  m221 ...............       Asp f 4 ........................................................................................   Aspergillus fumigatus.
                                                  m222 ...............       Asp f 6.0101 ...............................................................................       Aspergillus fumigatus.
                                                  m223 ...............       Staphylococal enterotoxin C (Sta a SEC) .................................                          Staphylococus aureus.
                                                  m224 ...............       Staphylococcal enterotoxin D (Sta a SED) ...............................                           Staphylococcus aureus.
                                                  m226 ...............       Staphylococcal enterotoxin TSST (Sta a TSST) .......................                               Staphylococcus aureus.
                                                  m227 ...............       Malassezia spp. (Pityrosporum spp.) ........................................                       Malassezia spp. (Pityrosporum spp.).
                                                  m228 ...............       Aspergillus flavus..
                                                  m229 ...............       Alt a 1.0101 ................................................................................      Alternaria alternata (Alternaria tenuis).
                                                  m230 ...............       Alt a 6.0101 ................................................................................      Alternaria alternata (Alternaria tenuis).
                                                  m231 ...............       Cla h 8.0101 ..............................................................................        Cladosporium herbarum (Hormodendrum).
                                                  m300 ...............       Eurotium spp. .............................................................................        Eurotium spp.
                                                  m304 ...............       Aspergillus oryzae ......................................................................          Aspergillus oryzae.
                                                  m305 ...............       Penicillium brevicompactum ......................................................                  Penicillium brevicompactum.
                                                  m309 ...............       Aspergillus terreus .....................................................................          Aspergillus terreus.
                                                  m310 ...............       Aspergillus nidulans ...................................................................           Aspergillus nidulans.
                                                  m311 ...............       Aspergillus flavus .......................................................................         Aspergillus flavus.
                                                  m312 ...............       Aspergillus clavatus ...................................................................           Aspergillus clavatus.

                                                                                                                                                Epidermal & Animal

                                                  e6 ....................    Guinea pig epithelium ................................................................             Cavia porcellus.
                                                  e7 ....................    Pigeon droppings .......................................................................           Columba palumbus
                                                                                                                                                                                Columba livia.
                                                  e25 ..................     Chicken serum ...........................................................................          Gallus domesticus
                                                                                                                                                                                (Gallus gallus domesticus; Gallus spp.).
mstockstill on DSK30JT082PROD with NOTICES




                                                  e26   ..................   Parrot serum ..............................................................................        Psittacoidea spp.
                                                  e62   ..................   Camel .........................................................................................    Camelus dromedaries.
                                                  e70   ..................   Goose feathers ..........................................................................          Anser anser.
                                                  e71   ..................   Mouse epithelium .......................................................................           Mus musculus
                                                                                                                                                                                (Mus spp.).
                                                  e73 ..................     Rat epithelium ............................................................................        Rattus norvegicus.
                                                  e74 ..................     Rat urine proteins ......................................................................          Rattus norvegicus
                                                                                                                                                                                Rattus rattus.



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                                                  31996                                     Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                    TABLE 3—CLASS II DEVICES—Continued
                                                                                                         [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                            Source
                                                   Allergen code                                                Allergen product                                                                      (taxonomical name)

                                                  e75 ..................     Rat serum proteins ....................................................................            Rattus norvegicus
                                                                                                                                                                                Rattus rattus.
                                                  e76 ..................     Mouse serum proteins ...............................................................               Mus musculus
                                                                                                                                                                                (Mus spp.).
                                                  e77   ..................   Budgerigar droppings .................................................................             Melopsittacus undulatus.
                                                  e78   ..................   Budgerigar feathers ...................................................................            Melopsittacus undulatus.
                                                  e79   ..................   Budgerigar serum proteins ........................................................                 Melopsittacus undulatus.
                                                  e80   ..................   Goat epithelium ..........................................................................         Capra hircus.
                                                  e81   ..................   Sheep epithelium .......................................................................           Ovis aries
                                                                                                                                                                                (Ovis spp.).
                                                  e82 ..................     Rabbit epithelium .......................................................................          Oryctolagus cuniculus
                                                                                                                                                                                (Oryctolagus spp.).
                                                  e83 ..................     Swine epithelium ........................................................................          Sus scrofa
                                                                                                                                                                                (Sus scrofa domesticus; Sus spp.).
                                                  e84 ..................     Hamster epithelium ....................................................................            Cricetus cricetus, Mesocricetus auratus, and Phodopus
                                                                                                                                                                                  sungorus.
                                                  e85 ..................     Chicken feathers ........................................................................          Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
                                                  e86 ..................     Duck feathers .............................................................................        Anas platyrhynchos.
                                                  e87 ..................     Rat epithelium, serum proteins, and urine proteins ..................                              Rattus norvegicus
                                                                                                                                                                                Rattus rattus.
                                                  e88   ..................   Mouse epithelium, serum proteins, and urine proteins (mouse)                                       Mus musculus (Mus spp.).
                                                  e89   ..................   Turkey feathers ..........................................................................         Meleagris gallopavo.
                                                  e90   ..................   Budgerigar serum proteins, feathers, and droppings ................                                Melopsittacus undulatus.
                                                  e91   ..................   Pigeon serum proteins, feathers, and droppings ......................                              Streptopelia roseogrisea
                                                                                                                                                                                Psittacidae spp.
                                                  e92 ..................     Parrot serum proteins, feathers, and droppings ........................                            Ara spp.
                                                  e93 ..................     Pigeon serum proteins ...............................................................              Streptopelia roseogrisea.
                                                  e94 ..................     Fel d 1.0101 ...............................................................................       Felis domesticus.
                                                  a345 ................      Fel d 1 ........................................................................................   Felis domesticus.
                                                  e98 ..................     Parrot droppings ........................................................................          Psittacoidea spp.
                                                  e101 ................      Can f 1.0101 ..............................................................................        Canis familiaris (Canis domesticus).
                                                  a174 ................      Can f 1 .......................................................................................    Canis familiaris (Canis domesticus).
                                                  e102 ................      Can f 2.0101 ..............................................................................        Canis familiaris (Canis domesticus).
                                                  e196 ................      Parakeet feathers .......................................................................          Nymphicus hollandicus.
                                                  e197 ................      Parakeet droppings ....................................................................            Nymphicus hollandicus.
                                                  e198 ................      Parakeet serum ..........................................................................          Nymphicus hollandicus.
                                                  e199 ................      Canary bird serum .....................................................................            Serinus canarius.
                                                  e200 ................      Canary bird droppings ...............................................................              Serinus canarius.
                                                  e201 ................      Canary bird feathers (Canary feathers) .....................................                       Serinus canarius.
                                                  e202 ................      Reindeer epithelium ...................................................................            Rangifer tarandus.
                                                  e203 ................      Mink epithelium ..........................................................................         Mustela spp.
                                                  e204 ................      Bos d 6 .......................................................................................    Bos domesticus (Bos taurus; Bos spp.).
                                                  e205 ................      Horse, serum proteins ...............................................................              Equus caballus (Equus spp.).
                                                  e206 ................      Rabbit, serum proteins ...............................................................             Oryctolagus cuniculus (Oryctolagus spp.).
                                                  e208 ................      Chinchilla epithelium ..................................................................           Chinchilla laniger.
                                                  e209 ................      Gerbil epithelium ........................................................................         Meriones unguiculatus.
                                                  e210 ................      Fox epithelium ............................................................................        Vulpes vulpes.
                                                  e211 ................      Rabbit, urine proteins .................................................................           Oryctolagus cuniculus
                                                                                                                                                                                (Oryctolagus spp.).
                                                  e212 ................      Swine, urine proteins .................................................................            Sus scrofa
                                                                                                                                                                                (Sus scrofa domesticus; Sus spp.).
                                                  e213 ................      Parrot feathers ...........................................................................        Ara spp.
                                                  e214 ................      Finch feathers ............................................................................        Lonchura domestica.
                                                  e215 ................      Pigeon feathers ..........................................................................         Streptopelia roseogrisea
                                                                                                                                                                                (Streptopelia spp.)
                                                                                                                                                                                Columbia spp.
                                                  e216    ................   Deer epithelium ..........................................................................         Dama dama.
                                                  e217    ................   Ferret epithelium ........................................................................         Mustela putorius.
                                                  e218    ................   Chicken droppings .....................................................................            Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
                                                  e219    ................   Chicken, serum proteins ............................................................               Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
                                                  e220    ................   Fel d 2, Cat serum albumin .......................................................                 Felis domesticus.
mstockstill on DSK30JT082PROD with NOTICES




                                                  e221    ................   Can f 3 .......................................................................................    Canis familiaris (Canis domesticus)
                                                                                                                                                                                (Dog serum albumin).
                                                  e222    ................   Swine serum albumin (Sus s PSA) ...........................................                        Sus scrofa (Sus scrofa domesticus; Sus spp.).
                                                  e225    ................   Lovebird feathers .......................................................................          Psittacoidea agapomis.
                                                  e226    ................   Can f 5.0101 ..............................................................................        Canis familiaris.
                                                  e227    ................   Equ c 1.0101 ..............................................................................        Equus caballus.
                                                  e228    ................   Fel d 4.0101 ...............................................................................       Felis domesticus.
                                                  e230    ................   Equ c 3 .......................................................................................    Equus caballus.



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                                                                                             Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                                     31997

                                                                                                                      TABLE 3—CLASS II DEVICES—Continued
                                                                                                           [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                               Source
                                                   Allergen code                                                  Allergen product                                                                       (taxonomical name)

                                                  e231 ................       Mus m 1 .....................................................................................        Mus musculus.

                                                                                                                                                               Food

                                                  f9 .....................    Rice ............................................................................................    Oryza sativa.
                                                  f12 ...................     Pea (green pea) .........................................................................            Pisum sativum.
                                                  f15 ...................     White bean .................................................................................         Phaseolus vulgaris.
                                                  f19 ...................     Cayenne pepper ........................................................................              Capsicum frutescens
                                                                                                                                                                                   (Capsicum annum).
                                                  f21   ...................   Sugar cane .................................................................................         Saccharum officinarum.
                                                  f22   ...................   Raspberry ...................................................................................        Rubus idaeus.
                                                  f26   ...................   Pork ............................................................................................    Sus scrofa (Sus scrofa domesticus; Sus spp.).
                                                  f29   ...................   Watermelon ................................................................................          Citrullus lanatus
                                                                                                                                                                                   (Citrullus vulgaris).
                                                  f31   ...................   Carrot .........................................................................................     Daucus carota.
                                                  f32   ...................   Oyster mushroom ......................................................................               Pleurotus ostreatus.
                                                  f33   ...................   Orange .......................................................................................       Citrus sinensis.
                                                  f35   ...................   Potato .........................................................................................     Solanum tuberosum.
                                                  f43   ...................   Mother’s milk ..............................................................................         Homo sapiens.
                                                  f44   ...................   Strawberry ..................................................................................        Fragaria vesca (Fragaria spp.).
                                                  f45   ...................   Yeast, baker’s ............................................................................          Saccharomyces cerevisiae.
                                                  f46   ...................   Pepper, Red ...............................................................................          Capsicum annuum.
                                                  f47   ...................   Garlic ..........................................................................................    Allium sativum.
                                                  f48   ...................   Onion ..........................................................................................     Allium cepa.
                                                  f49   ...................   Apple ..........................................................................................     Malus x domestica
                                                                                                                                                                                   (Malus spp.).
                                                  f51   ...................   Bamboo shoot ............................................................................            Phyllostachys pubescens.
                                                  f52   ...................   Cacao/chocolate ........................................................................             Theobroma cacao.
                                                  f54   ...................   Sweet potato ..............................................................................          Ipomoea batatas.
                                                  f55   ...................   Common millet ...........................................................................            Panicum miliaceum.
                                                  f56   ...................   Foxtail millet ...............................................................................       Setaria italica.
                                                  f57   ...................   Japanese millet ..........................................................................           Echinochloa crus-galli.
                                                  f58   ...................   Pacific squid ...............................................................................        Todarodes pacificus.
                                                  f59   ...................   Octopus ......................................................................................       Octopus vulgaris (Octopus spp.).
                                                  f63   ...................   Kefir ............................................................................................   NA.
                                                  f67   ...................   Parmesan cheese ......................................................................               NA.
                                                  f81   ...................   Cheese, cheddar type ................................................................                NA.
                                                  f82   ...................   Cheese, mold type .....................................................................              NA.
                                                  f83   ...................   Chicken ......................................................................................       Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
                                                  f86   ...................   Parsley .......................................................................................      Petroselinum crispum.
                                                  f87   ...................   Melon .........................................................................................      Cucumis melo Cucumis melo + Citrullus lanatus.
                                                  f88   ...................   Mutton (lamb) .............................................................................          Ovis aries (Ovis spp.).
                                                  f90   ...................   Malt ............................................................................................    Hordeum vulgare.
                                                  f92   ...................   Banana .......................................................................................       Musa spp.
                                                  f93   ...................   Cacao .........................................................................................      Theobroma cacao.
                                                  f94   ...................   Pear ............................................................................................    Pyrus communis (Pyrus spp.).
                                                  f97   ...................   Yam ............................................................................................     Dioscorea spp.
                                                                                                                                                                                   Dioscorea opposita.
                                                  f97 ...................     Chamomile tea ...........................................................................            Matricaria chamomilla.
                                                  f98 ...................     Gliadin ........................................................................................     Triticum aestivum (Triticum spp.).
                                                  f102 .................      Cantaloupe .................................................................................         Cucumis melo var. cantalupensis.
                                                  f105 .................      Chocolate ...................................................................................        Theobroma cacao.
                                                  f109 .................      Cottonseed .................................................................................         Gossypium hirsutum.
                                                  f110 .................      Giant radish ................................................................................        Raphanus sativus.
                                                  f118 .................      Zucchini ......................................................................................      Cucurbita pepo.
                                                  f119 .................      Radish ........................................................................................      Raphanus sativus.
                                                  f120 .................      Venison ......................................................................................       Capreolus capeolus.
                                                  f121 .................      Pinto bean ..................................................................................        Phaseolus vulgaris.
                                                  f122 .................      Cheese, American .....................................................................               NA.
                                                  f127 .................      Black-eyed pea ..........................................................................            Vigna unguiculata.
                                                  f131 .................      Black Olive .................................................................................        Olea europaea.
                                                  f136 .................      Red beet ....................................................................................        Beta vulgaris var. conditiva.
mstockstill on DSK30JT082PROD with NOTICES




                                                  f139 .................      Goat’s Cheese ...........................................................................            Capra aegagrus.
                                                  f140 .................      Bran ............................................................................................    NA.
                                                  f141 .................      Corn (vegetables) ......................................................................             Zea mays.
                                                  f152 .................      Green bell pepper ......................................................................             Capsicum annuum.
                                                  f155 .................      Brewer’s yeast ...........................................................................           Saccharomyces carlsbergensis.
                                                  f157 .................      Duck ...........................................................................................     Anas domesticus.
                                                  f158 .................      Goose .........................................................................................      Anser anser.
                                                  f160 .................      Camembert cheese ....................................................................                NA.



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                                                  31998                                     Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                     TABLE 3—CLASS II DEVICES—Continued
                                                                                                          [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                              Source
                                                   Allergen code                                                 Allergen product                                                                       (taxonomical name)

                                                  f162 .................     Nectarine ....................................................................................       Prunus persica var. nucipersica.
                                                  f163 .................     Kohlrabi ......................................................................................      Brassica oleracea var. gongylodes.
                                                  f65 ...................    Perch.
                                                  f166 .................     Leek ...........................................................................................     Allium porrum.
                                                  f170 .................     Cheese (Switzerland) (Swiss cheese) .......................................                          NA.
                                                  f174 .................     Fig ..............................................................................................   Ficus carica.
                                                  f177 .................     Cranberry ...................................................................................        Vaccinium macrocarpon.
                                                  f179 .................     Raisin .........................................................................................     Vitis spp.
                                                  f182 .................     Lima bean ..................................................................................         Phaseolus lunatus.
                                                  f198 .................     Flaxseed (bruised grain) ............................................................                Linum usitatissimum.
                                                  f199 .................     Untreated native milk .................................................................              Bos domesticus (Bos taurus; Bos spp.).
                                                  f208 .................     Lemon ........................................................................................       Citrus limon.
                                                  f209 .................     Grapefruit ...................................................................................       Citrus paradisi.
                                                  f210 .................     Pineapple ...................................................................................        Ananas comosus.
                                                  f211 .................     Blackberry ..................................................................................        Rubus fruticosus.
                                                  f212 .................     Mushroom (champignon) ...........................................................                    Agaricus hortensis
                                                                                                                                                                                  (Agaricus spp.).
                                                  f213 .................     Rabbit .........................................................................................     Oryctolagus cuniculus
                                                                                                                                                                                  (Oryctolagus spp.).
                                                  f214   .................   Spinach ......................................................................................       Spinacia oleracea.
                                                  f215   .................   Lettuce .......................................................................................      Lactuca sativa.
                                                  f216   .................   Cabbage .....................................................................................        Brassica oleracea var. capitata.
                                                  f217   .................   Brussels sprouts ........................................................................            Brassica oleracea var. gem.
                                                  f218   .................   Paprika, sweet pepper ...............................................................                Capsicum annuum.
                                                  f219   .................   Fennel seed ...............................................................................          Foeniculum vulgare.
                                                  f219   .................   Sage ...........................................................................................     Salvia officinalis.
                                                  f220   .................   Cinnamon ...................................................................................         Cinnamomum spp.
                                                  f221   .................   Coffee .........................................................................................     Coffea spp.
                                                  f222   .................   Tea .............................................................................................    Camellia sinensis.
                                                  f223   .................   Green olive .................................................................................        Olea europaea.
                                                  f225   .................   Summer squash, pumpkin .........................................................                     Cucurbita pepo.
                                                  f225   .................   Pumpkin .....................................................................................        Cucurbita maxima.
                                                  f226   .................   Pumpkin seed ............................................................................            Cucurbita pepo.
                                                  f227   .................   Sugar-beet seed ........................................................................             Beta vulgaris.
                                                  f229   .................   Safflower Seed ...........................................................................           Carthamus tinctorius.
                                                  f231   .................   Milk, boiled .................................................................................       Bos domesticus
                                                                                                                                                                                  (Bos taurus; Bos spp.).
                                                  f234   .................   Vanilla ........................................................................................     Vanilla planifolia.
                                                  f237   .................   Apricot ........................................................................................     Prunus armeniaca.
                                                  f241   .................   Gouda cheese ............................................................................            NA.
                                                  f242   .................   Cherry ........................................................................................      Prunus avium.
                                                  f244   .................   Cucumber ...................................................................................         Cucumis sativus.
                                                  f246   .................   Guar, guar gum ..........................................................................            Cyamopsis tetragonoloba.
                                                  f247   .................   Honey .........................................................................................      NA.
                                                  f248   .................   Rosemary ...................................................................................         Rosmarinus officinalis.
                                                  f254   .................   Plaice .........................................................................................     Pleuronectes platessa.
                                                  f255   .................   Plum ...........................................................................................     Prunus domestica
                                                                                                                                                                                  Prunus americana.
                                                  f258 .................     Squid ..........................................................................................     Loligo spp.
                                                  f259 .................     Grape .........................................................................................      Vitis vinifera
                                                                                                                                                                                  (Vitis spp.).
                                                  f260   .................   Broccoli ......................................................................................      Brassica oleracea var. italica (Brassica oleracea var. cultivar).
                                                  f261   .................   Asparagus ..................................................................................         Asparagus officinalis.
                                                  f262   .................   Aubergine, eggplant ...................................................................              Solanum melongena.
                                                  f263   .................   Green pepper .............................................................................           Piper nigrum
                                                                                                                                                                                  Capsicum annuum.
                                                  f264   .................   Eel ..............................................................................................   Anguilla anguilla.
                                                  f265   .................   Caraway .....................................................................................        Carum carvi.
                                                  f265   .................   Cumin .........................................................................................      Cuminum cyminum.
                                                  f266   .................   Mace ..........................................................................................      Myristica fragrans.
                                                  f267   .................   Cardamon ..................................................................................          Elettaria cardamomum.
                                                  f268   .................   Clove ..........................................................................................     Syzygium aromaticum.
mstockstill on DSK30JT082PROD with NOTICES




                                                  f269   .................   Basil ...........................................................................................    Ocimum basilicum.
                                                  f270   .................   Ginger ........................................................................................      Zingiber officinale.
                                                  f271   .................   Anise ..........................................................................................     Pimpinella anisum.
                                                  f272   .................   Tarragon .....................................................................................       Artemisia dracunculus.
                                                  f273   .................   Thyme ........................................................................................       Thymus vulgaris.
                                                  f274   .................   Marjoram ....................................................................................        Origanum majorana.
                                                  f275   .................   Lovage .......................................................................................       Levisticum officinale.
                                                  f276   .................   Fennel, fresh ..............................................................................         Foeniculum vulgare.



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                                                                                             Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                                31999

                                                                                                                     TABLE 3—CLASS II DEVICES—Continued
                                                                                                          [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                               Source
                                                   Allergen code                                                 Allergen product                                                                        (taxonomical name)

                                                  f277   .................   Dill ..............................................................................................   Anethum graveolens.
                                                  f278   .................   Bay leaf ......................................................................................       Laurus nobilis.
                                                  f279   .................   Chili pepper ................................................................................         Capsicum frutescens.
                                                  f280   .................   Black pepper ..............................................................................           Piper nigrum.
                                                  f281   .................   Curry (Santa Maria) ...................................................................               NA.
                                                  f282   .................   Nutmeg .......................................................................................        Myristica fragrans.
                                                  f283   .................   Oregano .....................................................................................         Origanum vulgare.
                                                  f284   .................   Turkey meat ...............................................................................           Meleagris gallopavo.
                                                  f285   .................   Elk/moose meat .........................................................................              Alces spp.
                                                  f286   .................   Mare’s milk .................................................................................         Equus caballus (Equus spp.).
                                                  f287   .................   Red kidney bean ........................................................................              Phaseolus vulgaris.
                                                  f288   .................   Blueberry ....................................................................................        Vaccinium myrtillus (Vaccinium spp.).
                                                  f289   .................   Date ............................................................................................     Phoenix dactylifera.
                                                  f291   .................   Cauliflower .................................................................................         Brassica oleracea var. botrytis.
                                                  f292   .................   Guava .........................................................................................       Psidium guajava.
                                                  f293   .................   Papaya .......................................................................................        Carica papaya.
                                                  f294   .................   Passion fruit, Maracuja ..............................................................                Passiflora edulis (Passiflora spp.).
                                                  f295   .................   Carambola ..................................................................................          Averrhoa carambola.
                                                  f296   .................   Carob .........................................................................................       Ceratonia siliqua.
                                                  f297   .................   Gum arabic ................................................................................           Acacia senegal (Acacia spp.).
                                                  f298   .................   Tragacanth .................................................................................          Astragalus spp.
                                                  f299   .................   Sweet chestnut (chestnut) .........................................................                   Castanea sativa.
                                                  f300   .................   Pinto bean ..................................................................................         Phaseolus spp.
                                                  f301   .................   Persimmon (kaki fruit, sharon) ...................................................                    Diospyros kaki.
                                                  f302   .................   Mandarin (tangerine, clementine, satsumas) ............................                               Citrus reticulata.
                                                  f305   .................   Fenugreek ..................................................................................          Trigonella foenum-graecum.
                                                  f306   .................   Lime ...........................................................................................      Citrus aurantifolia.
                                                  f307   .................   Hake ...........................................................................................      Merluccius merluccius.
                                                  f308   .................   Sardine (pilchard) .......................................................................            Sardina pilchardus.
                                                  f310   .................   Blue vetch ..................................................................................         Lathyrus sativus.
                                                  f311   .................   Megrim .......................................................................................        Lepidorhombus whiffiagonis.
                                                  f315   .................   Green bean ................................................................................           Phaseolus vulgaris.
                                                  f316   .................   Rape seed ..................................................................................          Brassica napus.
                                                  f317   .................   Coriander ...................................................................................         Coriandrum sativum.
                                                  f318   .................   Jack fruit .....................................................................................      Artocarpus heterophyllus.
                                                  f319   .................   Beetroot ......................................................................................       Beta vulgaris.
                                                  f320   .................   Crayfish ......................................................................................       Astacus astacus.
                                                  f321   .................   Horse meat ................................................................................           Equus caballus (Equus spp.).
                                                  f322   .................   Red currant ................................................................................          Ribes sylvestre.
                                                  f324   .................   Hop (fruit cone) ..........................................................................           Humulus lupulus.
                                                  f325   .................   Saffron ........................................................................................      Colchicum autumnale.
                                                  f328   .................   Fig ..............................................................................................    Ficus carica.
                                                  f329   .................   Watermelon ................................................................................           Citrullus lanatus.
                                                  f330   .................   Rose hip .....................................................................................        Rosa spp.
                                                  f331   .................   Saffron ........................................................................................      Crocus sativus.
                                                  f332   .................   Mint ............................................................................................     Mentha piperita.
                                                  f333   .................   Linseed .......................................................................................       Linum usitatissimum.
                                                  f336   .................   Jujube .........................................................................................      Ziziphus jujuba.
                                                  f336   .................   Wine vinegar ..............................................................................           Vitis vinifera (Vitis spp.).
                                                  f337   .................   Sole ............................................................................................     Solea solea.
                                                  f337   .................   English sole ................................................................................         Parophrys vetulus.
                                                  f338   .................   Wine, white ................................................................................          Vitis vinifera (Vitis spp.).
                                                  f339   .................   Allspice .......................................................................................      Pimenta dioica.
                                                  f339   .................   Wine, red ....................................................................................        Vitis vinifera (Vitis spp.).
                                                  f341   .................   Cranberry ...................................................................................         Vaccinium oxycoccus
                                                                                                                                                                                   Vaccinium macrocarpon.
                                                  f342   .................   Olive (black, fresh) .....................................................................            Olea europaea.
                                                  f343   .................   Raspberry ...................................................................................         Rubus idaeus.
                                                  f344   .................   Sage ...........................................................................................      Salvia officinalis.
                                                  f346   .................   Chives ........................................................................................       Allium schoenoprasum.
                                                  f347   .................   Quinoa ........................................................................................       Chenopodium quinoa.
                                                  f348   .................   Litchi ...........................................................................................    Litchi chinensis.
mstockstill on DSK30JT082PROD with NOTICES




                                                  f349   .................   Chum salmon roe ......................................................................                Oncorhynchus keta.
                                                  f358   .................   Artichoke ....................................................................................        Cynara scolymus.
                                                  f360   .................   Yogurt .........................................................................................      NA.
                                                  f368   .................   Black bass ..................................................................................         Micropterus dolomieu (Micropterus dolomieui).
                                                  f374   .................   Karaya gum ................................................................................           Sterculia urens.
                                                  f375   .................   Horseradish ................................................................................          Armoracia rusticana.
                                                  f377   .................   Maple syrup ...............................................................................           NA.
                                                  f379   .................   Okra ...........................................................................................      Abelmoschus esculentus.



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                                                  32000                                      Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                                                                                      TABLE 3—CLASS II DEVICES—Continued
                                                                                                           [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                               Source
                                                   Allergen code                                                  Allergen product                                                                       (taxonomical name)

                                                  f382   .................    Beet, sugar .................................................................................        Beta vulgaris var. altissima.
                                                  f401   .................    Loquat ........................................................................................      Eriobotrya japonica.
                                                  f402   .................    Fig ..............................................................................................   Ficus carica.
                                                  f403   .................    Brewer’s yeast ...........................................................................           Saccharomyces cerevisiae.
                                                  f405   .................    Mint ............................................................................................    Mentha spp.
                                                  f406   .................    Arugula .......................................................................................      Eruca vesicaria.

                                                                                                                                                         House Dust

                                                  h1 ....................     Greer Labs., Inc. ........................................................................           NA.
                                                  h2 ....................     Hollister-Stier Labs. ....................................................................           NA.
                                                  h6 ....................     Japan .........................................................................................      NA.

                                                                                                                                                    Venoms & Insects

                                                  i7 .....................    Midge .........................................................................................      Chironomus yoshimatsui.
                                                  i8 .....................    Moth ...........................................................................................     Bombyx mori
                                                                                                                                                                                   Heterocera spp.
                                                  i47   ...................   Water flea ...................................................................................       Daphnia spp.
                                                  i49   ...................   Deer fly .......................................................................................     Chrysops spp.
                                                  i51   ...................   Black ant ....................................................................................       Camponotus pennsylvanicus.
                                                  i54   ...................   Flea mix (dog/cat), common flea ...............................................                      Ctenocephalides spp.
                                                  i71   ...................   Mosquito .....................................................................................       Aedes communis
                                                                                                                                                                                   Aedes spp. and Culex spp.
                                                  i72 ...................     Green nimitti ...............................................................................        Cladotanytarsus lewisi.
                                                  i73 ...................     Blood worm ................................................................................          Chironomus thummi
                                                                                                                                                                                   Chironomusri parius
                                                                                                                                                                                   Chironomus spp.
                                                  i75 ...................     European hornet ........................................................................             Vespa crabro.
                                                  i76 ...................     Berlin beetle ...............................................................................        Trogoderma angustum.
                                                  i77 ...................     European paper wasp ................................................................                 Polistes dominulus.
                                                  i78 ...................     Fly ..............................................................................................   Musca domestica.
                                                  i80 ...................     Bumblebee .................................................................................          Bombus pennsylvanicus.
                                                  i201 .................      Horse bot fly ...............................................................................        Gasterophilus intestinalis.
                                                  i202 .................      Grain weevil ...............................................................................         Sitophilus granarius.
                                                  i203 .................      Mediterranean flour moth ...........................................................                 Ephestia kuehniella (Anagasta kuehniella).
                                                  i204 .................      Horse fly .....................................................................................      Tabanus spp.
                                                  i205 .................      Bumblebee .................................................................................          Bombus terrestris.
                                                  i208 .................      Api m 1.0101 ..............................................................................          Apis mellifera.
                                                  a45 ..................      Api m 1 .......................................................................................      Apis mellifera.
                                                  i209 .................      Ves v 5.0101 ..............................................................................          Vespula vulgaris.
                                                  a670 ................       Ves v 5 .......................................................................................      Vespula vulgaris.
                                                  i210 .................      Pol d 5.0101 ...............................................................................         Polistes dominulus.
                                                  i211 .................      Ves v 1.0101 ..............................................................................          Vespula vulgaris.
                                                  i213 .................      Api m 4 .......................................................................................      Apis mellifera.
                                                  i214 .................      Api m 2 .......................................................................................      Apis mellifera.
                                                  i215 .................      Api m 3 .......................................................................................      Apis mellifera.
                                                  i216 .................      Api m 5 .......................................................................................      Apis mellifera.
                                                  i217 .................      Api m 10 .....................................................................................       Apis mellifera.
                                                  i220 .................      Bla g 1.0101 ...............................................................................         Blattella germanica.
                                                  i221 .................      Bla g 2.0101 ...............................................................................         Blattella germanica.
                                                  i222 .................      Bla g 5.0101 ...............................................................................         Blattella germanica.
                                                  i223 .................      Bla g 7 ........................................................................................     Blattella germanica
                                                  a46 ..................      Api m 2 .......................................................................................      Apis mellifera.

                                                                                                                                                       Miscellaneous

                                                  o1 ....................     Cotton, crude fibers ...................................................................             Gossypium spp.
                                                  o3 ....................     Cotton (treated) ..........................................................................          Gossypium spp.
                                                  o70 ..................      Seminal fluid ..............................................................................         Homo sapiens.
                                                  o71 ..................      Staphylococcus aureus ..............................................................                 Staphylococcus aureus.
                                                  o72 ..................      Pichia pastoris crude extract customer specific ........................                             Pichia pastoris.
mstockstill on DSK30JT082PROD with NOTICES




                                                  o72 ..................      Sperm-sediment .........................................................................             Homo sapiens.
                                                  o73 ..................      Pichia pastoris crude extr. vector customer specific .................                               Pichia pastoris.
                                                  o74 ..................      Pichia pastoris with vector customer specific ............................                           Pichia pastoris.
                                                  o201 ................       Tobacco leaf, tobacco dust ........................................................                  Nicotiana tabacum.
                                                  o202 ................       Artemia salina, fish feed ............................................................               Artemia salina.
                                                  o203 ................       Tetramin, fish feed .....................................................................            NA.
                                                  o207 ................       Daphnia, fish feed ......................................................................            Daphnia spp.
                                                  o211 ................       Mealworm ...................................................................................         Tenebrio molitor.



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                                                                                           Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices                                                                     32001

                                                                                                                    TABLE 3—CLASS II DEVICES—Continued
                                                                                                         [§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

                                                                                                                                                                                                             Source
                                                   Allergen code                                                Allergen product                                                                       (taxonomical name)

                                                  o212 ................     Streptavidin ................................................................................        Streptomyces avidini.
                                                  o213 ................     MBP (maltose binding protein) ..................................................                     Escherichia coli.
                                                  o214 ................     CCD; MUXF3 from bromelain ....................................................                       Ananas comosus.
                                                  o72 ..................    Enterotoxin A (Sta a SEA) .........................................................                  Staphylococcus aureus.
                                                  o73 ..................    Enterotoxin B (Sta a SEB) .........................................................                  Staphylococcus aureus.

                                                                                                                                                         Parasites

                                                  p1 ....................   Ascaris .......................................................................................      Ascaris suum.
                                                  p2 ....................   Echinococcus .............................................................................           Echinococcus granulosus.
                                                  p3 ....................   Schistosoma ...............................................................................          Schistosoma mansoni.
                                                  p4 ....................   Anisakis (Herring Worm) ............................................................                 Anisakis simplex (Anisakis spp.).
                                                  p5 ....................   Toxocara canis ...........................................................................           Toxocara canis.
                                                  p10 ..................    Ani s 3.0101 ...............................................................................         Anisakis simplex (Anisakis spp.).
                                                  p11 ..................    Ani s 1 ........................................................................................     Anisakis simplex (Anisakis spp.).

                                                                                                                                                      Occupational

                                                  k4 ....................   Threshing dust ...........................................................................           NA.
                                                  k5 ....................   Flax ............................................................................................    NA.
                                                  k7 ....................   Hay Dust ....................................................................................        NA.
                                                  k8 ....................   Hop (hops) .................................................................................         Humulus lupulus.
                                                  k12 ..................    Grain mill dust ............................................................................         NA.
                                                  k14 ..................    Kapok .........................................................................................      NA.
                                                  k20 ..................    Sheep’s wool (treated) (wool) ....................................................                   Ovis aries (Ovis spp.).
                                                  k21 ..................    Sheep’s wool (Untreated) ..........................................................                  Ovis aries (Ovis spp.).
                                                  k23 ..................    Straw Dust .................................................................................         NA.
                                                  k33 ..................    Oak .............................................................................................    NA.
                                                  k70 ..................    Green coffee bean .....................................................................              Coffea spp.
                                                  k71 ..................    Castor bean ...............................................................................          Ricinus communis.
                                                  k72 ..................    Ispaghula ....................................................................................       Plantago psyllium/Plantago ovata.
                                                  k73 ..................    Silk waste ...................................................................................       NA.
                                                  k74 ..................    Silk .............................................................................................   Bombyx mori.
                                                  k75 ..................    Isocyanate TDI (Toluene diisocyanate) .....................................                          NA.
                                                  k76 ..................    Isocyanate MDI (Diphenylmethane diisocyanate) .....................                                  NA.
                                                  k77 ..................    Isocyanate HDI (Hexamethylen diisocyanate) ...........................                               NA.
                                                  k78 ..................    Ethylene oxide ...........................................................................           NA.
                                                  k79 ..................    Phthalic anhydride .....................................................................             NA.
                                                  k80 ..................    Formaldehyde/Formalin .............................................................                  NA.
                                                  k81 ..................    Ficus ...........................................................................................    Ficus benjamina (Ficus spp.).
                                                  k83 ..................    Cotton seed ................................................................................         Gossypium hirsutum.
                                                  k84 ..................    Sunflower seed ..........................................................................            Helianthus annuus.
                                                  k85 ..................    Chloramin T ...............................................................................          NA.
                                                  k86 ..................    Trimellitic anhydride, TMA .........................................................                 NA.
                                                  k87 ..................    Asp o 21, alpha-amylase ...........................................................                  Aspergillus oryzae.
                                                  k89 ..................    Orris root ....................................................................................      Iris florentina.
                                                  k99 ..................    HSA (Human Serum Albumin) (Hom s HSA) ............................                                   Homo sapiens.
                                                  k201 ................     Car p 1, Papain ..........................................................................           Carica papaya.
                                                  k202 ................     Ana c 2, Bromelain ....................................................................              Ananas comosus.
                                                  k204 ................     Maxatase ....................................................................................        Bacillus licheniformis.
                                                  k205 ................     Alcalase ......................................................................................      Bacillus spp.
                                                  k206 ................     Savinase, Protease 1 (Bac l Subtilisin) .....................................                        Bacillus spp.
                                                  k208 ................     Gal d 4, Lysozyme .....................................................................              Gallus domesticus (Gallus gallus domesticus; Gallus spp.).
                                                  k209 ................     Hexahydrophtalic anhydrid ........................................................                   NA.
                                                  k210 ................     Maleic anhydride ........................................................................            NA.
                                                  k211 ................     Methyltetrahydrophtalic anhydrid ...............................................                     NA.
                                                  k212 ................     Abachi wood dust ......................................................................              Triplochiton scleroxylon.
                                                  k213 ................     Pepsin (Sus s Pepsin) ...............................................................                Sus scrofa (Sus scrofa domesticus; Sus spp.).
                                                  k213 ................     TCPA ..........................................................................................      NA.
                                                  k214 ................     Bougainvillea ..............................................................................         Bougainvillea spp.
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                                                  k225 ................     Horse radish peroxidase (Arm r HRP) ......................................                           Armoracia rusticana.
                                                  k226 ................     Ascorbate oxidase (Cuc p ascorbate oxidase) ..........................                               Cucurbita pepo.
                                                  k301 ................     Flour dust ...................................................................................       Triticum spp.
                                                  k501 ................     Savinase customer specific .......................................................                   Proprietary knowledge of customer.
                                                  k502 ................     Lipolase customer specific .........................................................                 Proprietary knowledge of customer.
                                                  k503 ................     Termamyl customer specific ......................................................                    Proprietary knowledge of customer.
                                                  k504 ................     Clazinase customer specific ......................................................                   Proprietary knowledge of customer.



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                                                  32002                           Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices

                                                  V. Reference                                             extension acted with due diligence                       Instructions: All submissions received
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mstockstill on DSK30JT082PROD with NOTICES




                                                                                                                                                                 and/or go to the Dockets Management
                                                  SUPPLEMENTARY INFORMATION section) are                     • For written/paper comments
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                                             VerDate Sep<11>2014   18:01 Jul 10, 2017   Jkt 241001   PO 00000   Frm 00070   Fmt 4703   Sfmt 4703   E:\FR\FM\11JYN1.SGM   11JYN1



Document Created: 2018-11-14 10:21:15
Document Modified: 2018-11-14 10:21:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactBryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: [email protected]
FR Citation82 FR 31976 

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