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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 June 17, 2024

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four 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 provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Toxicology

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
862.3030 Acetaminophen test system.    
  LDP -  Colorimetry, Acetaminophen II
862.3035 Amikacin test system.    
  KLP -  Amikacin Serum Assay II
  KLQ -  Radioimmunoassay, Amikacin II
  LDN -  Enzymatic Radiochemical Assay, Amikacin II
  LGJ -  Fluorescence Polarization Immunoassay, Amibacin II
862.3040 Alcohol test system.    
  DIC -  Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method II
  DIZ -  Delayed Analysis, Alcohol II
  DLA -  Test Reagents For Methyl Alcohol II
  DLH -  Gas Chromatography, Alcohol II
  DLS -  Gas Chromatograph, Alcohol (Dedicated Instruments) II
  DMI -  Potassium Dichromate Specific Reagent For Alcohol II
  DMJ -  Test Reagents For Ethyl Alcohol II
  DML -  Nad-Nadh, Specific Reagent For Alcohol Enzyme Method II
  DMT -  Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet II
  DOJ -  Potassium Dichromate, Alcohol II
862.3100 Amphetamine test system.    
  NVI -  Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease II
  DIT -  Thin Layer Chromatography, Amphetamine II
  DJL -  Free Radical Assay, Amphetamine II
  DJP -  Radioimmunoassay, Amphetamine II
  DKZ -  Enzyme Immunoassay, Amphetamine II
  DNI -  Liquid Chromatography, Amphetamine II
  DOD -  Gas Chromatography, Amphetamine II
  DPJ -  Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep. II
  NFT -  Test, Amphetamine, Over The Counter II
  OIW -  Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types II
862.3110 Antimony test system.    
  DNE -  Atomic Absorption, Antimony I
862.3120 Arsenic test system.    
  DNZ -  Atomic Absorption, Arsenic I
862.3150 Barbiturate test system.    
  DIS -  Enzyme Immunoassay, Barbiturate II
  DJN -  Mercury Dithiazone, Colorimetry, Barbiturate II
  DKN -  Radioimmunoassay, Barbiturate II
  DKX -  Thin Layer Chromatography, Barbiturate II
  DLX -  Hemagglutination Inhibition, Barbiturate II
  DMF -  Gas Liquid Chromatography, Barbiturate II
  KZY -  High Pressure Liquid Chromatography, Barbiturate II
  PTH -  Test, Barbiturate, Over The Counter II
862.3170 Benzodiazepine test system.    
  JXM -  Enzyme Immunoassay, Benzodiazepine II
  KZZ -  Gas Chromatography, Benzodiazepine II
  LAA -  High Pressure Liquid Chromatography, Benzodiazepine II
  LAB -  Thin Layer Chromatography, Benzodiazepine II
  NFV -  Test, Benzodiazepine, Over The Counter II
862.3250 Cocaine and cocaine metabolite test system.    
  DIN -  Gas Chromatography, Cocaine II
  DIO -  Enzyme Immunoassay, Cocaine And Cocaine Metabolites II
  DIR -  Free Radical Assay, Cocaine II
  DLN -  Hemagglutination, Cocaine Metabolites (Benzoylecgnonine) II
  DMN -  Thin Layer Chromatography, Cocaine II
  DNG -  Free Radical, Benzoylecgnonine II
  DOM -  Thin Layer Chromatography, Benzoylecgnonine II
  JXO -  Enzyme Immunoassay, Cocaine II
  KLN -  Radioimmunoassay, Cocaine Metabolite II
  LAC -  High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites II
  NFY -  Test, Cocaine And Cocaine Metabolites, Over The Counter II
862.3270 Codeine test system.    
  DLD -  Thin Layer Chromatography, Codeine II
  LAD -  Gas Chromatography, Codeine II
  LAE -  High Pressure Liquid Chromatography, Codeine II
862.3300 Digitoxin test system.    
  DKQ -  Antiserum, Digitoxin II
  DND -  Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep. II
  DNW -  Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep. II
  DOB -  Radioimmunoassay, Digitoxin (3-H) II
  DOW -  Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube II
  DPG -  Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep. II
  DPL -  Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep. II
  LCW -  Radioimmunoassay, Digitoxin (125-I) II
  LFM -  Enzyme Immunoassay, Digitoxin II
862.3320 Digoxin test system.    
  DKA -  Antiserum, Digoxin II
  DNJ -  Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep. II
  DNL -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. II
  DNQ -  Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep. II
  DNS -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep. II
  DOA -  Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. II
  DOG -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol II
  DON -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. II
  DOR -  Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep. II
  DOY -  Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. II
  DPB -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. II
  DPD -  Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep. II
  DPI -  Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep. II
  DPO -  Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. II
  KXT -  Enzyme Immunoassay, Digoxin II
  LAN -  Enzyme Immunoassay, N-Acetylprocainamide II
  LAR -  Enzyme Immunoassay, Procainamide II
  LBZ -  Enzyme Immunoassay, Quinidine II
  LCS -  Radioimmunoassay, Digoxin (125-I) II
  LCT -  Radioimmunoassay, Digoxin (3-H) II
862.3350 Diphenylhydantoin test system.    
  DIP -  Enzyme Immunoassay, Diphenylhydantoin II
  DKH -  Gas Chromatography, Diphenylhydantoin II
  DLP -  Radioimmunoassay, Diphenylhydantoin II
  DOZ -  Liquid Chromatography, Diphenylhydantoin II
  DPE -  Thin Layer Chromatography, Diphenylhydantoin II
  LDC -  U.V. Spectrometry, Diphenylhydantoin II
  LES -  Fluorescent Immunoassay, Diphenylhydantoin II
  LFO -  Nephelometric Inhibition Immunoassay, Diphenylhydantoin II
  LGR -  Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) II
  MOJ -  Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) II
  NWM -  Immunoassay, Anti-Seizure Drug II
  ORH -  Lamotrigine Assay II
  ORI -  Levetiracetam Assay II
  OTF -  Gabapentin Assay II
862.3360 Drug metabolizing enzyme genotyping system.    
  NTI -  Drug Metabolizing Enzyme Genotyping Systems II
  ODW -  Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System II
862.3380 Ethosuximide test system.    
  DIY -  Gas Chromatography, Ethosuximide II
  DJX -  Radioimmunoassay, Ethosuximide II
  DLF -  Enzyme Immunoassay, Ethosuximide II
  DNF -  Liquid Chromatography, Ethosuximide II
  DNP -  Thin Layer Chromatography, Ethosuximide II
862.3450 Gentamicin test system.    
  DJB -  Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. II
  DJI -  Antiserum, Gentamicin II
  DKD -  Bacillus Subtilis, Microbiological Assay, Gentamicin II
  DNO -  Hemagglutination Inhibition, Gentamicin II
  KLO -  Enzymatic Radiochemical Assay, Gentamicin II
  KZT -  Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin II
  LCD -  Enzyme Immunoassay, Gentamicin II
  LCQ -  Fluorescent Immunoassay Gentamicin II
862.3520 Kanamycin test system.    
  KJI -  Radioimmunoassay, Kanamycin II
  KZW -  Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin II
862.3555 Lidocaine test system.    
  KLR -  Enzyme Immunoassay, Lidocaine II
862.3560 Lithium test system.    
  JIH -  Flame Photometry, Lithium II
  JII -  Atomic Absorption, Lithium II
  NDW -  Assay, Porphyrin, Spectrophotometry, Lithium II
862.3580 Lysergic acid diethylamide (LSD) test system.    
  DLB -  Radioimmunoassay, Lsd (125-I) II
  DOL -  Free Radical Assay, Lsd II
862.3590 Meprobamate test system.    
  QBK -  Meprobamate Test System II
862.3600 Mercury test system.    
  DPH -  Mercury, Atomic Absorption I
862.3610 Methamphetamine test system.    
  DJC -  Thin Layer Chromatography, Methamphetamine II
  LAF -  Gas Chromatography, Methamphetamine II
  LAG -  High Pressure Liquid Chromatography, Methamphetamine II
  NGG -  Test, Methamphetamine, Over The Counter II
862.3620 Methadone test system.    
  DIW -  Hemagglutination Inhibition, Methadone II
  DJR -  Enzyme Immunoassay, Methadone II
  DKR -  Thin Layer Chromatography, Methadone II
  DMB -  Gas Chromatography, Methadone II
  DNT -  Liquid Chromatography, Methadone II
  DPP -  Free Radical Assay, Methadone II
  PTG -  Test, Methadone, Over The Counter II
862.3630 Methaqualone test system.    
  KXS -  Radioimmunoassay, Methaqualone II
862.3640 Morphine test system.    
  DIQ -  Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep. II
  DJJ -  Fluorometry, Morphine II
  DLR -  Hemagglutination Inhibition, Morphine II
  DMY -  Gas Chromatography, Morphine II
  DNA -  Radioimmunoassay, Morphine-Barbiturate (125-I), Goat Antibody II
  DNK -  Thin Layer Chromatography, Morphine II
  DOE -  Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. II
  DOK -  Free Radical Assay, Morphine II
  DPK -  Liquid Chromatography, Morphine II
  NGI -  Test, Morphine, Over The Counter II
862.3645 Neuroleptic drugs radioreceptor assay test system.    
  DLE -  Reagents, Test, Bromides II
  JKQ -  Gold Chloride (Colorimetric), Bromide II
  KLT -  Enzyme Immunoassay, Carbamazepine II
  LDB -  U.V. Spectrometry, Carbamazepine II
  LEG -  Enzyme Immunoassay, Valproic Acid II
  LGI -  Fluorescence Polarization Immunoassay, Carbamazepine II
  LPX -  Radioceptor Assay, Neuroleptic Drugs II
  POX -  Enzyme Immunoassay, Oxcarbazepine Metabolite II
862.3650 Opiate test system.    
  DJF -  Gas Chromatography, Opiates II
  DJG -  Enzyme Immunoassay, Opiates II
  DKT -  Free Radical Assay, Opiates II
  DLT -  Hemagglutination, Opiates II
  LAH -  High Pressure Liquid Chromatography, Opiates II
  LAI -  Thin Layer Chromatography, Opiates II
  NGL -  Test, Opiates, Over The Counter II
862.3660 Phenobarbital test system.    
  DIX -  Thin Layer Chromatography, Phenobarbital II
  DJH -  Gas Chromatography, Phenobarbital II
  DKP -  Radioimmunoassay, Phenobarbital II
  DLZ -  Enzyme Immunoassay, Phenobarbital II
  DOO -  Liquid Chromatography, Phenobarbital II
  LDA -  U.V. Spectrometry, Phenobarbital II
  LET -  Fluorescent Immunoassay, Phenobarbital II
  LFN -  Nephelometric Inhibition Immunoassay, Phenobarbital II
  LGQ -  Fluorescence Polarization Immunoassay, Phenobarbital II
862.3670 Phenothiazine test system.    
  DJQ -  Test Reagents For Phenothiazine II
862.3680 Primidone test system.    
  DIL -  Radioimmunoassay, Primidone II
  DJD -  Enzyme Immunoassay, Primidone II
  DMQ -  Gas Chromatography, Primidone II
  DOS -  Thin Layer Chromatography, Primidone II
  DPQ -  Liquid Chromatography, Primidone II
  LCZ -  U.V. Spectrometry, Primidone II
  LFT -  Fluorescent Immunoassay, Primidone II
862.3700 Propoxyphene test system.    
  DPN -  Thin Layer Chromatography, Propoxyphene II
  JXN -  Enzyme Immunoassay, Propoxyphene II
  LAJ -  Gas Chromatography, Propoxyphene II
  LAK -  High Pressure Liquid Chromatography, Propoxyphene II
  QBF -  Test, Propoxyphene, Over The Counter II
862.3750 Quinine test system.    
  DIK -  Thin Layer Chromatography, Quinine I
  LAL -  Eas Chromatography, Quinine I
  LAM -  High Pressure Liquid Chromatography, Quinine I
862.3830 Salicylate test system.    
  DIM -  Gas Chromatography, Salicylate II
  DJE -  Thin Layer Chromatography, Salicylate II
  DKJ -  Colorimetry, Salicylate II
  DMX -  Liquid Chromatography, Salicylate II
  DNC -  Strip, Paper, Salicylate II
862.3840 Sirolimus test system.    
  NRP -  Sirolimus Test System II
  OAV -  Mycophenolic Acid Test System II
862.3850 Sulfonamide test system.    
  DKW -  Test Reagents For Sulphanimide Derivatives I
862.3870 Cannabinoid test system.    
  DKE -  Reagents, Test, Tetrahydrocannabinol II
  LAT -  Radioimmunoassay, Cannabinoid(S) II
  LDJ -  Enzyme Immunoassay, Cannabinoids II
  NFW -  Test, Cannabinoid, Over The Counter II
862.3880 Theophylline test system.    
  KLS -  Enzyme Immunoassay, Theophylline II
  LCA -  Radioimmunoassay, Theophylline II
  LCY -  U.V. Spectrometry, Theophylline II
  LER -  Fluorescent Immunoassay, Theophylline II
  LEW -  Thin Layer Chromatography, Theophylline II
  LGS -  Fluorescence Polarization Immunoassay, Theophylline II
862.3900 Tobramycin test system.    
  DID -  Bacillus Subtilis Microbiology Assay, Tobramycin II
  KLB -  Radioimmunoassay, Tobramycin II
  KZX -  Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin II
  LCR -  Fluorescent Immunoassay, Tobramycin II
  LDO -  Enzymatic Radiochemical Assay, Tobramycin II
  LFW -  Fluorescence Polarization Immunoassay, Tobramycin II
862.3910 Tricyclic antidepressant drugs test system.    
  LFG -  Radioimmunoassay, Tricyclic Antidepressant Drugs II
  LFH -  U.V. Spectrometry, Tricyclic Antidepressant Drugs II
  LFI -  High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs II
  MLK -  Thin Layer Chromatography, Tricyclic Antidepressant Drugs II
  QAW -  Test, Tricyclic Antidepressants, Over The Counter II
862.3950 Vancomycin test system.    
  LEH -  Radioimmunoassay, Vancomycin II

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