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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 November 29, 2021

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

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