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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 10, 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.


Clinical Chemistry

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
862.1025 Adrenocorticotropic hormone (ACTH) test system.    
  CKG -  Radioimmunoassay, Acth II
862.1035 Albumin test system.    
  CIX -  Bromcresol Green Dye-Binding, Albumin II
  CJF -  Tetrabromophenolphthalein, Albumin II
  CJG -  Tetrabromo-M-Cresolsulfonphthalein, Albumin II
  CJQ -  Radial Immunodiffusion, Albumin II
  CJW -  Bromcresol Purple Dye-Binding, Albumin II
  CJZ -  Acid, Hydroxyazobenzene-Benzoic, Albumin II
862.1045 Aldosterone test system.    
  CJB -  Chromatographic Separation/Radioimmunoassay, Aldosterone II
  CJM -  Radioimmunoassay, Aldosterone II
862.1050 Alkaline phosphatase or isoenzymes test system.    
  CIN -  Electrophoretic Separation, Alkaline Phosphatase Isoenzymes II
  CIO -  Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes II
  CJE -  Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes II
  CJH -  Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes II
  CJI -  Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes II
  CJK -  Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes II
  CJL -  Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes II
  CJO -  Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes II
  CKF -  Phenylphosphate, Alkaline Phosphatase Or Isoenzymes II
  NEO -  System, Test, Osteocalcin II
862.1065 Ammonia test system.    
  JID -  Photometric Method, Ammonia I
  JIE -  Method, Ion-Exchange, Ammonia I
  JIF -  Enzymatic Method, Ammonia I
  JIG -  Electrode, Ion-Specific Method, Ammonia I
862.1070 Amylase test system.    
  CIJ -  Saccharogenic, Amylase II
  CIK -  Radial Diffusion, Amylase II
  CIW -  Starch-Dye Bound Polymer, Amylase II
  CJA -  Amyloclastic, Amylase II
  CJD -  Nitrosalicylate Reduction, Amylase II
  JFJ -  Catalytic Methods, Amylase II
  KHM -  Nephelometric, Amylase II
862.1085 Angiotensin I and renin test system.    
  CIB -  Radioimmunoassay, Angiotensin I And Renin II
862.1110 Bilirubin (total or direct) test system.    
  CIG -  Diazo Colorimetry, Bilirubin II
  JFM -  Enzymatic Method, Bilirubin II
862.1113 Bilirubin (total and unbound) in the neonate test system.    
  MQM -  Bilirubin (Total And Unbound) In The Neonate Test System I
862.1118 Biotinidase test system.    
  NAK -  System, Test, Biotinidase II
862.1120 Blood gases (PCO2, PO2) and blood pH test system.    
  CHL -  Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph II
862.1140 Calcitonin test system.    
  JKR -  Radioimmunoassay, Calcitonin II
862.1145 Calcium test system.    
  CHC -  Titrimetric Permanganate And Bromophenol Blue, Calcium II
  CHW -  Titrimetric With Edta And Indicator, Calcium II
  CHZ -  Di (O-Hydroxyphenylimine) Ethane, Calcium II
  CIA -  Methylthymol Blue, Calcium II
  CIC -  Cresolphthalein Complexone, Calcium II
  CID -  Alizarin Sulfonate, Calcium II
  CJY -  Azo Dye, Calcium II
  JFN -  Atomic Absorption, Calcium II
  JFO -  Fluorometric, Calcium II
  JFP -  Electrode, Ion Specific, Calcium II
862.1155 Human chorionic gonadotropin (HCG) test system.    
  DHA -  System, Test, Human Chorionic Gonadotropin II
  JHI -  Visual, Pregnancy Hcg, Prescription Use II
  JHJ -  Agglutination Method, Human Chorionic Gonadotropin II
  LCX -  Kit, Test, Pregnancy, Hcg, Over The Counter II
  LFS -  Radioreceptor Assay, Human Chorionic Gonadotropin II
  NAL -  Test, Immunoassay, Biosensor, Hcg II
862.1160 Bicarbonate/carbon dioxide test system.    
  CHR -  Titrimetric Phenol Red, Carbon-Dioxide II
  CHS -  Coulometric Method, Carbon-Dioxide II
  CIE -  Volumetric/Manometric, Carbon-Dioxide II
  CIL -  Cresol Red Colorimetry, Carbon-Dioxide II
  JFL -  Ph Rate Measurement, Carbon-Dioxide II
  KHS -  Enzymatic, Carbon-Dioxide II
  KMS -  Phenolphthalein Colorimetry, Carbon-Dioxide II
862.1170 Chloride test system.    
  CGZ -  Electrode, Ion-Specific, Chloride II
  CHG -  Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride II
  CHJ -  Mercuric Thiocyanate, Colorimetry, Chloride II
  CHK -  Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride II
  JFS -  Coulometric, Chloride II
862.1175 Cholesterol (total) test system.    
  NAQ -  Lipoprotein, High Density, Hdl, Over The Counter I
  NFX -  Test, Cholesterol, Total, Over The Counter I
862.1177 Cholylglycine test system.    
  KWW -  Radioimmunoassay, Cholyglycine, Bile Acids II
862.1187 Conjugated sulfolithocholic acid (SLCG) test system.    
  KWX -  Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids II
862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.    
  CGR -  Radioimmunoassay, Cortisol II
  JFT -  Fluorometric, Cortisol II
  NHG -  Enzyme Immunoassay, Cortisol, Salivary II
862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.    
  CGS -  Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes II
  JHS -  Differential Rate Kinetic Method, Cpk Or Isoenzymes II
  JHT -  Chromatographic Separation, Cpk Isoenzymes II
  JHW -  U.V. Method, Cpk Isoenzymes II
  JHX -  Fluorometric Method, Cpk Or Isoenzymes II
  JHY -  Colorimetric Method, Cpk Or Isoenzymes II
  MYT -  Biosensor, Immunoassay, Cpk Or Isoenzymes II
  NJV -  Test, Albumin Cobalt Binding II
862.1225 Creatinine test system.    
  CGL -  Electrode, Ion Based, Enzymatic, Creatinine II
  CGX -  Alkaline Picrate, Colorimetry, Creatinine II
  JFY -  Enzymatic Method, Creatinine II
  NDY -  Test, Cystatin C II
862.1230 Cyclic AMP test system.    
  CGT -  Radioimmunoassay, Cyclic Gmp II
  CHO -  Radioimmunoassay, Cyclic Amp II
862.1235 Cyclosporine test system.    
  LTB -  Cyclosporine Radioimmunoassay II
  MAR -  Cyclosporine And Metabolites Serum Assay II
  MGS -  High Performance Liquid Chromatography For Cyclosporine II
  MGU -  Fluorescence Polarization Immunoassay For Cyclosporine II
  MGV -  Radioimmunoassay For Cyclosporine II
  MKW -  Cyclosporine II
862.1295 Folic acid test system.    
  CGN -  Acid, Folic, Radioimmunoassay II
862.1310 Galactose test system.    
  JIA -  Enzymatic Methods, Galactose I
  JIB -  U.V. Method, Galactose I
  JIC -  Colorimetric Method, Galactose I
862.1315 Galactose-1-phosphate uridyl transferase test system.    
  JLJ -  Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate II
  KQP -  Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase II
862.1340 Urinary glucose (nonquantitative) test system.    
  JIL -  Method, Enzymatic, Glucose (Urinary, Non-Quantitative) II
  JIM -  Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) II
862.1345 Glucose test system.    
  CFR -  Hexokinase, Glucose II
  CFW -  Copper Reduction, Glucose II
  CGA -  Glucose Oxidase, Glucose II
  CGD -  Ferricyanide, Glucose II
  CGE -  Orthotoluidine, Glucose II
  LFR -  Glucose Dehydrogenase, Glucose II
862.1377 Urinary homocystine (nonquantitative) test system.    
  LPS -  Urinary Homocystine (Nonquantitative) Test System II
862.1450 Lactic acid test system.    
  NGD -  Test, Lactic Acid, Over The Counter I
862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.    
  JHF -  Colorimetric Method, Lecithin/Sphingomyelin Ratio II
  JHG -  Chromatographic Separation, Lecithin/Sphingomyelin Ratio II
  JHH -  Electrophoretic Method, Lecithin/Sphingomyelin Ratio II
862.1475 Lipoprotein test system.    
  PYP -  Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test I
862.1495 Magnesium test system.    
  CFA -  Electrode, Ion Specific, Magnesium I
  CFO -  Titrimetric, Magnesium I
  JGI -  Atomic Absorption, Magnesium I
  JGJ -  Photometric Method, Magnesium I
862.1510 Nitrite (nonquantitative) test system.    
  NGJ -  Test, Nitrite, Urinary, Non-Quantitative, Over The Counter I
862.1540 Osmolality test system.    
  PFQ -  Mmp-9 Test System I
862.1545 Parathyroid hormone test system.    
  CEW -  Radioimmunoassay, Parathyroid Hormone II
862.1550 Urinary pH (nonquantitative) test system.    
  PDS -  Amniotic Fluid Protein Immunoassay I
862.1555 Phenylalanine test system.    
  JNB -  Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine II
  JNC -  Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine II
862.1585 Human placental lactogen test system.    
  JMF -  Radioimmunoassay, Human Placental Lactogen II
862.1600 Potassium test system.    
  CEJ -  Tetraphenyl Borate, Colorimetry, Potassium II
  CEM -  Electrode, Ion Specific, Potassium II
  JGM -  Flame Photometry, Potassium II
  MZV -  Test, System, Potassium, Enzymatic Method II
862.1665 Sodium test system.    
  CEI -  Uranyl Acetate/Zinc Acetate, Sodium II
  JGS -  Electrode, Ion Specific, Sodium II
  JGT -  Flame Photometry, Sodium II
  MZU -  System, Test, Sodium, Enzymatic Method II
862.1675 Blood specimen collection device.    
  GJE -  Tray, Blood Collection II
862.1678 Tacrolimus test system.    
  MLM -  Enzyme Immunoassay, Tracrolimus II
862.1680 Testosterone test system.    
  CDZ -  Radioimmunoassay, Testosterones And Dihydrotestosterone I
862.1690 Thyroid stimulating hormone test system.    
  JLW -  Radioimmunoassay, Thyroid-Stimulating Hormone II
862.1695 Free thyroxine test system.    
  CEC -  Radioimmunoassay, Free Thyroxine II
862.1705 Triglyceride test system.    
  NGO -  Test, Triglycerides, Over The Counter I
862.1730 Free tyrosine test system.    
  CDR -  1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine I
862.1770 Urea nitrogen test system.    
  CDL -  Berthelot Indophenol, Urea Nitrogen II
  CDN -  Urease, Photometric, Urea Nitrogen II
  CDQ -  Urease And Glutamic Dehydrogenase, Urea Nitrogen II
  CDS -  Electrode, Ion Specific, Urea Nitrogen II
  CDW -  Diacetyl-Monoxime, Urea Nitrogen II
  JGZ -  O-Phthalaldehyde, Urea Nitrogen II
  LFP -  Conductivity Rate, Urea Nitrogen II
862.1775 Uric acid test system.    
  PTC -  Uric Acid Test System For At Home Prescription Use I
862.1810 Vitamin B12 test system.    
  CDD -  Radioassay, Vitamin B12 II
  LIG -  Radioassay, Intrinsic Factor Blocking Antibody II
862.1825 Vitamin D test system.    
  MRG -  System, Test, Vitamin D II
862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.    
  LCI -  Automated Radioimmunoassay Systems, For Clinical Use I
  QBV -  Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate I

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