Advertisement
News
Advertisement

Guidance for Industry and Food and Drug Administration Staff - Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices

Tue, 12/20/2011 - 3:30am
U.S. Food & Drug Administration

For questions regarding this document, contact Scott McFarland at 301-796-6217, or via email at Scott.McFarland@fda.hhs.gov@fda.hhs.gov.

CDRH Logo

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Preface

You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

The devices subject to enforcement discretion:

Clinical Chemistry Devices

Devices classified under 21 CFR 862.1410 Iron (non-heme) test system, which includes the following product codes:

  • CFM - Bathophenanthroline, Colorimetry, Iron (Non-Heme)
  • JIY - Photometric Method, Iron (Non-Heme)
  • JIZ - Atomic Absorption, Iron (Non-Heme)
  • JJA - Radio-Labeled Iron Method, Iron (Non-Heme)

Devices classified under 21 CFR 862.1415 Iron-binding capacity test system, which includes the following product codes:

  • JMO - Ferrozine (Colorimetric) Iron Binding Capacity
  • JQD - Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity
  • JQE - Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
  • JQF - Bathophenanthroline, Iron Binding Capacity
  • JQG - Radiometric, Fe59, Iron Binding Capacity

Devices classified under 21 CFR 862.1580 Phosphorous (inorganic) test system, which includes the following product code:

  • CEO - Phosphomolybdate (Colorimetric), Inorganic Phosphorus

Devices classified under 21 CFR 862.1775 Uric acid test system, which includes the following product codes:

  • CDH - Acid, Uric, Phosphotungstate Reduction
  • CDO - Acid, Uric, Uricase (U.V.)
  • JHA - Acid, Uric, Uricase (Gasometric)
  • JHC - Acid, Uric, Uricase (Oxygen Rate)
  • KNK - Acid, Uric, Uricase (Colorimetric)
  • LFQ - Acid, Uric, Acid Reduction Of Ferric Ion

Devices classified under 21 CFR 862.3050 Breath - alcohol test system, which includes the following product code:

  • DJZ - Devices, Breath Trapping, Alcohol

Devices classified under 21 CFR 862.3220 Carbon monoxide test system, which includes the following product codes:

  • JKS - Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
  • JKT - Gas Chromatograph, Carbon-Monoxide
  • MKU - Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
  • MRS - Test System, Nicotine, Cotinine, Metabolites

Devices classified under 21 CFR 862.3240 Cholinesterase test system, which includes the following product codes:

  • DIG - Cholinesterase Test Paper
  • DIH - Colorimetry, Cholinesterase
  • DLI - Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
  • DMR - Solution, M-Nitrophenol, Specific Reagent For Cholinesterase
  • DOH - Electrometry, Cholinesterase

Devices classified under 21 CFR 862.1020 Acid phosphatase (total or prostatic) test system, which includes the following product codes:

  • CJN - Acid Phosphatase, Nitrophenylphosphate
  • CJR - Acid Phosphatase, Thymol Blue Monophosphate
  • CJX - Acid Phosphatase, Disodium Phenylphosphate
  • CKB - Acid Phosphatase, Naphthyl Phosphate
  • CKE - Acid Phosphatase, Thymolphthale Inmonophosphate
  • CKH - Acid Phosphatase, Beta Glycerophosphate
  • JFH - Acid Phosphatase (Prostatic), Tartrate Inhibited

Devices classified under 21 CFR 862.1090 Angiotensin converting enzyme (A.C.E) test system, which includes the following product code:

  • KQN - Radioassay, Angiotensin Converting Enzyme

Devices classified under 21 CFR 862.1100 Aspartate amino transferase (AST/SGOT) test system, which includes the following product codes:

  • CIF - Vanillin Pyruvate, Ast/Sgot
  • CIQ - Diazo, Ast/Sgot
  • CIS - Hydrazone Colorimetry, Ast/Sgot
  • CIT - Nadh Oxidation/Nad Reduction, Ast/Sgot

Devices classified under 21 CFR 862.1445 Lactate dehydrogenase isoenzymes test system, which includes the following product codes:

  • CEX - Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
  • CFE - Electrophoretic, Lactate Dehydrogenase Isoenzymes
  • JGF - Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes

Devices classified under 21 CFR 862.1509 Methylmalonic acid (non-quantitative) test system, which includes the following product code:

  • LPT - System, Test, Urinary Methylmalonic Acid

Devices classified under 21 CFR 862.1685 Thyroxine-binding globulin test system, which includes the following product code:

  • CEE - Radioimmunoassay, Thyroxine-Binding Globulin

Devices classified under 21 CFR 862.1700 Total thyroxine test system, which includes the following product codes:

  • CDX - Radioimmunoassay, Total Thyroxine
  • KLI - Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Hematology Devices

Devices classified under 21 CFR 864.6650 - Platelet adhesion test, which includes the following product code:

  • JBZ- Study, Platelet Adhesive

Devices classified under 21 CFR 864.7275 - Euglobulin lysis time tests, which includes the following product code:

  • JBO - Test, Euglobulin Lysis

Devices classified under 21 CFR 864.7300 - Fibrin monomer paracoagulation test, which includes the following product codes:

  • JBN - Fibrin Monomer Paracoagulation

Devices classified under 21 CFR 864.7375 - Glutathione reductase assay, which includes the following product codes:

  • GII - Glutathione, Red-Cell
  • JMH - Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase
  • KQF - Assay, Glutathione Reductase

Devices classified under 21 CFR 864.7720 Prothrombin consumption test, which includes the following product code:

  • GGQ - Test, Prothrombin Consumption

Devices classified under 21 CFR 864.7735 - Prothrombin-proconvertin test and thrombotest, which includes the following product code:

  • JPF- Prothrombin-Proconvertin And Thrombotest

Immunology and Microbiology Devices

Devices classified under 21 CFR 866.5470 - Hemoglobin immunological test system, which includes the following product code:

  • DAM - Hemoglobin, Chain Specific, Antigen, Antiserum, Control

Radiology Devices

Devices classified under 21 CFR 892.1610, Diagnostic x-ray beam-limiting device, which includes the following product codes:

  • IZS – Aperature, Radiographic
  • IZW – Collimator, Automatic, Radiographic
  • IZX – Collimator, Manual, Radiographic
  • IZT –Cone, Radiographic
  • KPW – Device, Beam Limiting, X-Ray, Diagnostic

Devices classified under 21 CFR 892.1670, Spot-film device, which includes the following product code:

  • IXL – Device, Spot-Film

Devices classified under 21 CFR 892.1850, Radiographic film cassette, which includes the following product code:

  • IXA – Cassette, Radiographic Film

Devices classified under 21 CFR 892.1860, Radiographic film/cassette changer, which includes the following product code:

  • KPX – Changer, Radiographic Film/Cassette

Devices classified under 21 CFR 892.1870, Radiographic film/cassette changer programmer, which includes the following product code:

  • IZP – Programmer, Changer, Film/Cassette, Radiographic

Devices classified under 21 CFR 892.1900, Automatic radiographic film processor, which includes the following product codes:

  • EGT – Controller, Temperature, Radiographic
  • EGW – Dryer, Film, Radiographic
  • IXX – Processor, Cine film
  • IXW – Processor, Radiographic-Film, Automatic
  • LEGY – Processor, Radiographic-Film, Automatic, Dental

Devices classified under 21 CFR 892.2030, Medical image digitizer, which includes the following product codes:

  • LMA – Digitizer, Image, Radiological
  • NFH – Digitizer, Images, Ophthalmic

Devices classified under 21 CFR 892.2040, Medical image hardcopy device, which includes the following product codes:

  • LMC – Camera, Multi Format, Radiological
  • NFI – Device, Hardcopy, Images, Ophthalmic

Devices classified under 21 CFR 892.1820 Pneumoencephalographic chair, which includes the following product codes:

  • HBK – Chair, Pneumocephalographic

SOURCE

Topics

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading