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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that FDA has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Toxicology

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
862.3030 Acetaminophen test system. II  
  LDP -  Colorimetry, Acetaminophen   Pilot  
862.3035 Amikacin test system. II  
  KLP -  Amikacin Serum Assay   Pilot  
  KLQ -  Radioimmunoassay, Amikacin   Pilot  
  LDN -  Enzymatic Radiochemical Assay, Amikacin   Pilot  
  LGJ -  Fluorescence Polarization Immunoassay, Amibacin   Pilot  
862.3040 Alcohol test system. II  
  DIC -  Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method   Pilot  
  DIZ -  Delayed Analysis, Alcohol   Pilot  
  DLA -  Test Reagents For Methyl Alcohol   Pilot  
  DLH -  Gas Chromatography, Alcohol   Pilot  
  DLS -  Gas Chromatograph, Alcohol (Dedicated Instruments)   Pilot  
  DMI -  Potassium Dichromate Specific Reagent For Alcohol   Pilot  
  DMJ -  Test Reagents For Ethyl Alcohol   Pilot  
  DML -  Nad-Nadh, Specific Reagent For Alcohol Enzyme Method   Pilot  
  DMT -  Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet   Pilot  
  DOJ -  Potassium Dichromate, Alcohol   Pilot  
862.3050 Breath-alcohol test system. I  
 General Guidance
  DJZ -  Devices, Breath Trapping, Alcohol      
862.3100 Amphetamine test system. II  
  DIT -  Thin Layer Chromatography, Amphetamine      
  DJL -  Free Radical Assay, Amphetamine      
  DJP -  Radioimmunoassay, Amphetamine      
  DKZ -  Enzyme Immunoassay, Amphetamine      
  DNI -  Liquid Chromatography, Amphetamine      
  DOD -  Gas Chromatography, Amphetamine      
  DPJ -  Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.      
  LCM -  Enzyme Immunoassay, Phencyclidine      
862.3110 Antimony test system. I  
 General Guidance
  DNE -  Atomic Absorption, Antimony      
862.3120 Arsenic test system. I  
 General Guidance
  DNZ -  Atomic Absorption, Arsenic      
862.3150 Barbiturate test system. II  
  DIS -  Enzyme Immunoassay, Barbiturate   Pilot  
  DJN -  Mercury Dithiazone, Colorimetry, Barbiturate   Pilot  
  DKN -  Radioimmunoassay, Barbiturate   Pilot  
  DKX -  Thin Layer Chromatography, Barbiturate   Pilot  
  DLX -  Hemagglutination Inhibition, Barbiturate   Pilot  
  DMF -  Gas Liquid Chromatography, Barbiturate   Pilot  
  KZY -  High Pressure Liquid Chromatography, Barbiturate   Pilot  
862.3170 Benzodiazepine test system. II  
  JXM -  Enzyme Immunoassay, Benzodiazipine   Pilot  
  KZZ -  Gas Chromatography, Benzodiazipine   Pilot  
  LAA -  High Pressure Liquid Chromatography, Benzodiazipine   Pilot  
  LAB -  Thin Layer Chromatography, Benzodiazipine   Pilot  
862.3200 Clinical toxicology calibrator. II  
PDF Guidance file for Clinical toxicology calibrator. (21CFR862.3200)  
  DKB -  Calibrators, Drug Mixture      
  DLJ -  Calibrators, Drug Specific      
  DNN -  Calibrators, Ethyl Alcohol      
862.3220 Carbon monoxide test system. I  
 General Guidance
  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      
862.3240 Cholinesterase test system. I  
 General Guidance
  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      
862.3250 Cocaine and cocaine metabolite test system. II  
  DIN -  Gas Chromatography, Cocaine      
  DIO -  Enzyme Immunoassay, Cocaine And Cocaine Metabolites      
  DIR -  Free Radical Assay, Cocaine      
  DLN -  Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)      
  DMN -  Thin Layer Chromatography, Cocaine      
  DNG -  Free Radical, Benzoylecgnonine      
  DOM -  Thin Layer Chromatography, Benzoylecgnonine      
  JXO -  Enzyme Immunoassay, Cocaine      
  KLN -  Radioimmunoassay, Cocaine Metabolite      
  LAC -  High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites      
862.3270 Codeine test system. II  
 
  DLD -  Thin Layer Chromatography, Codeine      
  LAD -  Gas Chromatography, Codeine      
  LAE -  High Pressure Liquid Chromatography, Codeine      
862.3280 Clinical toxicology control material. I  
 General Guidance
  DIE -  Heavy Metals Control Materials      
  DIF -  Drug Mixture Control Materials      
  DJK -  Digitoxin Control Serum, Ria      
  DKC -  Alcohol Control Materials      
  DMP -  Digoxin Control Serum, Ria      
  LAS -  Drug Specific Control Materials      
  LAW -  Theophylline Control Materials      
  LAX -  Lidocaine Control Materials      
  LAY -  Methotrexate Control Materials      
  LAZ -  N-Acetylprocainamide Control Materials      
  LBA -  Procainamide Control Materials      
862.3300 Digitoxin test system. II  
  DKQ -  Antiserum, Digitoxin   Pilot  
  DND -  Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.   Pilot  
  DNW -  Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.   Pilot  
  DOB -  Radioimmunoassay, Digitoxin (3-H)   Pilot  
  DOW -  Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube   Pilot  
  DPG -  Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.   Pilot  
  DPL -  Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep.   Pilot  
  LCW -  Radioimmunoassay, Digitoxin (125-I)   Pilot  
  LFM -  Enzyme Immunoassay, Digitoxin   Pilot  
862.3320 Digoxin test system. II  
  DKA -  Antiserum, Digoxin   Pilot  
  DNJ -  Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.   Pilot  
  DNL -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.   Pilot  
  DNQ -  Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep.   Pilot  
  DNS -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.   Pilot  
  DOA -  Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.   Pilot  
  DOG -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol   Pilot  
  DON -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.   Pilot  
  DOR -  Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.   Pilot  
  DOY -  Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.   Pilot  
  DPB -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.   Pilot  
  DPD -  Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.   Pilot  
  DPI -  Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep.   Pilot  
  DPO -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.   Pilot  
  KXT -  Enzyme Immunoassay, Digoxin   Pilot  
  LAN -  Enzyme Immunoassay, N-Acetylprocainamide   Pilot  
  LAR -  Enzyme Immunoassay, Procainamide   Pilot  
  LBZ -  Enzyme Immunoassay, Quinidine   Pilot  
  LCS -  Radioimmunoassay, Digoxin (125-I)   Pilot  
  LCT -  Radioimmunoassay, Digoxin (3-H)   Pilot  
862.3350 Diphenylhydantoin test system. II  
  DIP -  Enzyme Immunoassay, Diphenylhydantoin   Pilot  
  DKH -  Gas Chromatography, Diphenylhydantoin   Pilot  
  DLP -  Radioimmunoassay, Diphenylhydantoin   Pilot  
  DOZ -  Liquid Chromatography, Diphenylhydantoin   Pilot  
  DPE -  Thin Layer Chromatography, Diphenylhydantoin   Pilot  
  LDC -  U.V. Spectrometry, Diphenylhydantoin   Pilot  
  LES -  Fluorescent Immunoassay, Diphenylhydantoin   Pilot  
  LFO -  Nephelometric Inhibition Immunoassay, Diphenylhydantoin   Pilot  
  LGR -  Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)   Pilot  
  MOJ -  Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)   Pilot  
862.3380 Ethosuximide test system. II  
  DIY -  Gas Chromatography, Ethosuximide   Pilot  
  DJX -  Radioimmunoassay, Ethosuximide   Pilot  
  DLF -  Enzyme Immunoassay, Ethosuximide   Pilot  
  DNF -  Liquid Chromatography, Ethosuximide   Pilot  
  DNP -  Thin Layer Chromatography, Ethosuximide   Pilot  
862.3450 Gentamicin test system. II  
  DJB -  Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.   Pilot  
  DJI -  Antiserum, Gentamicin   Pilot  
  DKD -  Bacillus Subtlis, Microbiological Assay, Gentamicin   Pilot  
  DNO -  Hemagglutination Inhibition, Gentamicin   Pilot  
  KLO -  Enzymatic Radiochemical Assay, Gentamicin   Pilot  
  KZT -  Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin   Pilot  
  LCD -  Enzyme Immunoassay, Gentamicin   Pilot  
  LCQ -  Fluorescent Immunoassay Gentamicin   Pilot  
862.3520 Kanamycin test system. II  
  KJI -  Radioimmunoassay, Kanamycin   Pilot  
  KZW -  Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin   Pilot  
862.3550 Lead test system. II  
  DIJ -  Lead, Delta Amino Levulinic Acid   Pilot  
  DMK -  Lead, Protoporphyrin, Fluorometric   Pilot  
  DNX -  Lead, Protoporphyrin Zinc Method, Fluorometric   Pilot  
  DOF -  Lead, Atomic Absorption   Pilot  
  DOX -  Fluorometer, Lead (Dedicated Instruments)   Pilot  
862.3555 Lidocaine test system. II  
  KLR -  Enzyme Immunoassay, Lidocaine   Pilot  
862.3560 Lithium test system. II  
  JIH -  Flame Photometry, Lithium   Pilot  
  JII -  Atomic Absorption, Lithium   Pilot  
  NDW -  Assay, Porphyrin, Spectrophotometry, Lithium   Pilot  
862.3580 Lysergic acid diethylamide (LSD) test system. II  
  DLB -  Radioimmunoassay, Lsd (125-I)   Pilot  
  DOL -  Free Radical Assay, Lsd   Pilot  
862.3600 Mercury test system. I  
 General Guidance
  DPH -  Mercury, Atomic Absorption      
862.3610 Methamphetamine test system. II  
  DJC -  Thin Layer Chromatography, Metamphetamine      
  LAF -  Gas Chromatography, Methamphetamine      
  LAG -  High Pressure Liquid Chromatography, Methamphetamine      
862.3620 Methadone test system. II  
 
  DIW -  Hemagglutination Inhibition, Methadone      
  DJR -  Enzyme Immunoassay, Methadone      
  DKR -  Thin Layer Chromatography, Methadone      
  DMB -  Gas Chromatography, Methadone      
  DNT -  Liquid Chromatography, Methadone      
  DPP -  Free Radical Assay, Methadone      
862.3630 Methaqualone test system. II  
  KXS -  Radioimmunoassay, Methaqualone   Pilot  
862.3640 Morphine test system. II  
 
  DIQ -  Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.      
  DJJ -  Fluorometry, Morphine      
  DLR -  Hemagglutination Inhibition, Morphine      
  DMY -  Gas Chromatography, Morphine      
  DNA -  Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody      
  DNK -  Thin Layer Chromatography, Morphine      
  DOE -  Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.      
  DOK -  Free Radical Assay, Morphine      
  DPK -  Liquid Chromatography, Morphine      
862.3645 Neuroleptic drugs radioreceptor assay test system. II  
  DLE -  Reagents, Test, Bromides   Pilot  
  JKQ -  Gold Chloride (Colorimetric), Bromide   Pilot  
  KLT -  Enzyme Immunoassay, Carbamazepine   Pilot  
  LDB -  U.V. Spectrometry, Carbamazepine   Pilot  
  LEG -  Enzyme Immunoassay, Valproic Acid   Pilot  
  LGI -  Fluorescence Polarization Immunoassay, Carbamazepine   Pilot  
  LPX -  Radioceptor Assay, Neuroleptic Drugs   Pilot  
862.3650 Opiate test system. II  
  DJF -  Gas Chromatography, Opiates      
  DJG -  Enzyme Immunoassay, Opiates      
  DKT -  Free Radical Assay, Opiates      
  DLT -  Hemagglutination, Opiates      
  LAH -  High Pressure Liquid Chromatography, Opiates      
  LAI -  Thin Layer Chromatography, Opiates      
862.3660 Phenobarbital test system. II  
  DIX -  Thin Layer Chromatography, Phenobarbital   Pilot  
  DJH -  Gas Chromatography, Phenobarbital   Pilot  
  DKP -  Radioimmunoassay, Phenobarbital   Pilot  
  DLZ -  Enzyme Immunoassay, Phenobarbital   Pilot  
  DOO -  Liquid Chromatography, Phenobarbital   Pilot  
  LDA -  U.V. Spectrometry, Phenobarbital   Pilot  
  LET -  Fluorescent Immunoassay, Phenobarbital   Pilot  
  LFN -  Nephelometric Inhibition Immunoassay, Phenobarbital   Pilot  
  LGQ -  Fluorescence Polarization Immunoassay, Phenobarbital   Pilot  
862.3670 Phenothiazine test system. II  
  DJQ -  Test Reagents For Phenothiazine   Pilot  
862.3680 Primidone test system. II  
  DIL -  Radioimmunoassay, Primidone   Pilot  
  DJD -  Enzyme Immunoassay, Primidone   Pilot  
  DMQ -  Gas Chromatography, Primidone   Pilot  
  DOS -  Thin Layer Chromatography, Primidone   Pilot  
  DPQ -  Liquid Chromatography, Primidone   Pilot  
  LCZ -  U.V. Spectrometry, Primidone   Pilot  
  LFT -  Fluorescent Immunoassay, Primidone   Pilot  
862.3700 Propoxyphene test system. II  
  DPN -  Thin Layer Chromatography, Propoxyphene   Pilot  
  JXN -  Enzyme Immunoassay, Propoxyphene   Pilot  
  LAJ -  Gas Chromatography, Propoxyphene   Pilot  
  LAK -  High Pressure Liquid Chromatography, Propoxyphene   Pilot  
862.3750 Quinine test system. I  
 General Guidance
  DIK -  Thin Layer Chromatography, Quinine      
  LAL -  Eas Chromatography, Quinine      
  LAM -  High Pressure Liquid Chromatography, Quinine      
862.3830 Salicylate test system. II  
  DIM -  Gas Chromatography, Salicylate   Pilot  
  DJE -  Thin Layer Chromatography, Salicylate   Pilot  
  DKJ -  Colorimetry, Salicylate   Pilot  
  DMX -  Liquid Chromatography, Salicylate   Pilot  
  DNC -  Strip, Paper, Salicylate   Pilot  
862.3850 Sulfonamide test system. I  
 General Guidance
  DKW -  Test Reagents For Sulphanimide Derivatives      
862.3870 Cannabinoid test system. II  
  DKE -  Reagents, Test, Tetrahydrocannabinol      
  LAT -  Radioimmunoassay, Cannabinoid(S)      
  LDJ -  Enzyme Immunoassay, Cannabinoids      
862.3880 Theophylline test system. II  
  KLS -  Enzyme Immunoassay, Theophylline   Pilot  
  LCA -  Radioimmunoassay, Theophylline   Pilot  
  LCY -  U.V. Spectrometry, Theophylline   Pilot  
  LER -  Fluorescent Immunoassay, Theophylline   Pilot  
  LEW -  Thin Layer Chromatography, Theophylline   Pilot  
  LGS -  Fluorescence Polarization Immunoassay, Theophylline   Pilot  
862.3900 Tobramycin test system. II  
  DID -  Bacillus Subtlis Microbiology Assay, Tobramycin   Pilot  
  KLB -  Radioimmunoassay, Tobramycin   Pilot  
  KZX -  Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin   Pilot  
  LCR -  Fluorescent Immunoassay, Tobramycin   Pilot  
  LDO -  Enzymatic Radiochemical Assay, Tobramycin   Pilot  
  LFW -  Fluorescence Polarization Immunoassay, Tobramycin   Pilot  
862.3910 Tricyclic antidepressant drugs test system. II  
  LFG -  Radioimmunoassay, Tricyclic Antidepressant Drugs   Pilot  
  LFH -  U.V. Spectrometry, Tricyclic Antidepressant Drugs   Pilot  
  LFI -  High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs   Pilot  
  MLK -  Thin Layer Chroomatography, Tricyclic Antidepressant Drugs   Pilot  
862.3950 Vancomycin test system. II  
  LEH -  Radioimmunoassay, Vancomycin   Pilot  

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