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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.


Clinical Chemistry

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

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