List of Devices for Third Party Review under the FDA Modernization Act of 1997

List of Devices for Third Party Review under the FDA Modernization Act of 1997
Database updated: February 7, 2002

This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. In January 2001, FDA updated this list to include Class II devices that are part of the "expansion pilot," discussed below. 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ThirdPartyInspection/ucm125410.htm.

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.

You should contact FDA's Division of Small Manufacturers Assistance at dsma@cdrh.fda.gov or an Accredited Person if you need additional information on these exceptions.

Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA implemented an expansion pilot in January 2001 that allows Accredited Persons to review many Class II devices that were not previously eligible. The 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 a January 2001 guidance document entitled Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997. This guidance is a revision of the October 30, 1998 guidance document with the same title. 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.

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Clinical Chemistry Help Section No. Regulation Name Product Code-Device Name Class Pilot Relevant Guidance/Standard 862.1020 ACID PHOSPHATASE (TOTAL OR PROSTATIC) TEST SYSTEM II     CJN -  Acid Phosphatase, Nitrophenylphosphate   Pilot     CJR -  Acid Phosphatase, Thymol Blue Monophosphate   Pilot     CJX -  Acid Phosphatase, Disodium Phenylphosphate   Pilot     CKB -  Acid Phosphatase, Naphthyl Phosphate   Pilot     CKE -  Acid Phosphatase, Thymolphthale Inmonophosphate   Pilot     CKH -  Acid Phosphatase, Beta Glycerophosphate   Pilot     JFH -  Acid Phosphatase (Prostatic), Tartrate Inhibited   Pilot   862.1025 ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM II     CKG -  Radioimmunoassay, Acth   Pilot   862.1035 ALBUMIN TEST SYSTEM II     CIX -  Bromcresol Green Dye-Binding, Albumin   Pilot     CJF -  Tetrabromophenolphthalein, Albumin   Pilot     CJG -  Tetrabromo-M-Cresolsulfonphthalein, Albumin   Pilot     CJQ -  Radial Immunodiffusion, Albumin   Pilot     CJW -  Bromcresol Purple Dye-Binding, Albumin   Pilot     CJZ -  Acid, Hydroxyazobenzene-Benzoic, Albumin   Pilot   862.1045 ALDOSTERONE TEST SYSTEM II     CJB -  Chromatographic Separation/Radioimmunoassay, Aldosterone   Pilot     CJM -  Radioimmunoassay, Aldosterone   Pilot   862.1050 ALKALINE PHOSPHATASE OR ISOENZYMES TEST SYSTEM II     CIN -  Electrophoretic Separation, Alkaline Phosphatase Isoenzymes   Pilot     CIO -  Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes   Pilot     CJE -  Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   Pilot     CJH -  Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes   Pilot     CJI -  Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes   Pilot     CJK -  Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes   Pilot     CJL -  Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes   Pilot     CJO -  Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes   Pilot     CKF -  Phenylphosphate, Alkaline Phosphatase Or Isoenzymes   Pilot   862.1065 AMMONIA TEST SYSTEM I    General Guidance   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   Pilot     CIK -  Radial Diffusion, Amylase   Pilot     CIW -  Starch-Dye Bound Polymer, Amylase   Pilot     CJD -  Nitrosalicylate Reduction, Amylase   Pilot     JFJ -  Catalytic Methods, Amylase   Pilot     KHM -  Nephelometric, Amylase   Pilot   862.1085 ANGIOTENSIN I AND RENIN TEST SYSTEM II     CIB -  Radioimmunoassay, Angiotensin I And Renin   Pilot   862.1090 ANGIOTENSIN CONVERTING ENZYME TEST SYSTEM II     KQN -  Radioassay, Angiotensin Converting Enzyme   Pilot   862.1100 ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM II     CIF -  Vanillin Pyruvate, Ast/Sgot   Pilot     CIQ -  Diazo, Ast/Sgot   Pilot     CIS -  Hydrazone Colorimetry, Ast/Sgot   Pilot     CIT -  Nadh Oxidation/Nad Reduction, Ast/Sgot   Pilot   862.1110 BILIRUBIN (TOTAL AND DIRECT) TEST SYSTEM II     CIG -  Diazo Colorimetry, Bilirubin   Pilot     JFM -  Enzymatic Method, Bilirubin   Pilot   862.1113 BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM I    General Guidance   MQM -  Bilirubin (Total And Unbound) In The Neonate Test System       862.1118 BIOTINIDASE TEST SYSTEM II     NAK -  System,Test,Biotinidase   Pilot   862.1120 BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM II     CHL -  Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph   Pilot   862.1140 CALCITONIN TEST SYSTEM II     JKR -  Radioimmunoassay, Calcitonin   Pilot   862.1145 CALCIUM TEST SYSTEM II     CHC -  Titrimetric Permanganate And Bromophenol Blue, Calcium   Pilot     CHW -  Titrimetric With Edta And Indicator, Calcium   Pilot     CHZ -  Di (O-Hydroxyphenylimine) Ethane, Calcium   Pilot     CIA -  Methylthymol Blue, Calcium   Pilot     CIC -  Cresolphthalein Complexone, Calcium   Pilot     CID -  Alizarin Sulfonate, Calcium   Pilot     CJY -  Azo Dye, Calcium   Pilot     JFN -  Atomic Absorption, Calcium   Pilot     JFO -  Fluorometric, Calcium   Pilot     JFP -  Electrode, Ion Specific, Calcium   Pilot   862.1150 CALIBRATOR II     JIS -  Calibrator, Primary         JIT -  Calibrator, Secondary         JIW -  Calibrator, Surrogate         JIX -  Calibrator, Multi-Analyte Mixture       862.1155 HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM II     DHA -  System, Test, Human Chorionic Gonadotropin         JHI -  Radioimmunoassay, Human Chorionic Gonadotropin         JHJ -  Agglutination Method, Human Chorionic Gonadotropin         LFS -  Radioreceptor Assay, Human Chorionic Gonadotropin         NAL -  Test,Immunoassay,Biosensor,Hcg   Pilot   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       862.1177 CHOLYLGLYCINE TEST SYSTEM II     KWW -  Radioimmunoassay, Cholyglycine, Bile Acids   Pilot   862.1187 CONJUGATED SULFOLITHOCHOLIC ACID (SLCG) TEST SYSTEM II     KWX -  Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids   Pilot   862.1205 CORTISOL (HYDROCORTISONE AND HYDROXYCORTICOSTERONE) TEST SYSTEM II     CGR -  Radioimmunoassay, Cortisol   Pilot     JFT -  Fluorometric, Cortisol   Pilot     NHG -  Enzyme Immunoassay, Cortisol, Salivary   Pilot   862.1215 CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM II     CGS -  Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   Pilot     JHS -  Differential Rate Kinetic Method, Cpk Or Isoenzymes   Pilot     JHT -  Chromatographic Separation, Cpk Isoenzymes   Pilot     JHW -  U.V. Method, Cpk Isoenzymes   Pilot     JHX -  Fluorometric Method, Cpk Or Isoenzymes   Pilot     JHY -  Colorimetric Method, Cpk Or Isoenzymes   Pilot     MMI -  Immunoassay Method, Troponin Subunit   Pilot     MYT -  Biosensor, Immunoassay, Cpk Or Isoenzymes   Pilot   862.1225 CREATININE TEST SYSTEM II     CGL -  Electrode, Ion Based, Enzymatic, Creatinine         CGX -  Alkaline Picrate, Colorimetry, Creatinine         JFY -  Enzymatic Method, Creatinine       862.1230 CYCLIC AMP TEST SYSTEM II     CGT -  Radioimmunoassay, Cyclic Gmp   Pilot     CHO -  Radioimmunoassay, Cyclic Amp   Pilot   862.1295 FOLIC ACID TEST SYSTEM II     CGN -  Acid, Folic, Radioimmunoassay   Pilot   862.1310 GALACTOSE TEST SYSTEM I    General Guidance   JIA -  Enzymatic Methods, Galactose         JIB -  U.V. Method, Galactose         JIC -  Colorimetric Method, Galactose       862.1315 GALACTOSE-1-PHOSPHATE URIDYLTRANSFERASE TEST SYSTEM II     JLJ -  Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate   Pilot     KQP -  Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase   Pilot   862.1340 URINARY GLUCOSE (NONQUANTITATIVE) TEST SYSTEM II     JIL -  Method, Enzymatic, Glucose (Urinary, Non-Quantitative)         JIM -  Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)   Pilot   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         MRV -  Drink, Glucose Tolerance       862.1377 URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM II     LPS -  Urinary Homocystine (Nonquantitative) Test System   Pilot   862.1410 IRON (NON-HEME) TEST SYSTEM I    General Guidance   CFM -  Bathophenanthroline, Colorimetry, Iron (Non-Heme)         JIY -  Photometric Method, Iron (Non-Heme)         JIZ -  Atomic Absorption, Iron (Non-Heme)         JJA -  Radio-Labeled Iron Method, Iron (Non-Heme)       862.1415 IRON-BINDING CAPACITY TEST BINDING I    General Guidance   JMO -  Ferrozine (Colorimetric) Iron Binding Capacity         JQD -  Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity         JQE -  Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity         JQF -  Bathophenanthroline, Iron Binding Capacity         JQG -  Radiometric, Fe59, Iron Binding Capacity       862.1445 LACTATE DEHYDROGENASE ISOENZYMES TEST SYSTEM II     CEX -  Chromatographic Separation, Lactate Dehydrogenase Isoenzymes   Pilot     CFE -  Electrophoretic, Lactate Dehydrogenase Isoenzymes   Pilot     JGF -  Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes   Pilot   862.1455 LECITHIN/SPHINGOMYELIN RATIO IN AMNIOTIC FLUD TEST SYSTEM II     JHF -  Colorimetric Method, Lecithin/Sphingomyelin Ratio   Pilot     JHG -  Chromatographic Separation, Lecithin/Sphingomyelin Ratio   Pilot     JHH -  Electrophoretic Method, Lecithin/Sphingomyelin Ratio   Pilot   862.1495 MAGNESIUM TEST SYSTEM I    General Guidance   CFA -  Electrode, Ion Specific, Magnesium         CFO -  Titrimetric, Magnesium         JGI -  Atomic Absorption, Magnesium         JGJ -  Photometric Method, Magnesium       862.1509 URINARY METHYLMALONIC ACID TEST SYSTEM II     LPT -  System, Test, Urinary Methylmalonic Acid   Pilot   862.1545 PARATHYROID HORMONE TEST SYSTEM II     CEW -  Radioimmunoassay, Parathyroid Hormone   Pilot   862.1555 PHENYLALANINE TEST SYSTEM II     JNB -  Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine   Pilot     JNC -  Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine   Pilot   862.1580 PHOSPHORUS (INORGANIC) TEST SYSTEM I    General Guidance   CEO -  Phosphomolybdate (Colorimetric), Inorganic Phosphorus       862.1585 HUMAN PLACENTAL LACTOGEN TEST SYSTEM II     JMF -  Radioimmunoassay, Human Placental Lactogen   Pilot   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       862.1660 QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) I    General Guidance   JJR -  Electrolyte Controls (Assayed And Unassayed)         JJS -  Controls For Blood-Gases, (Assayed And Unassayed)         JJT -  Enzyme Controls (Assayed And Unassayed)         JJW -  Urinalysis Controls (Assayed And Unassayed)         JJX -  Single (Specified) Analyte Controls (Assayed And Unassayed)         JJY -  Multi-Analyte Controls, All Kinds (Assayed)         LCH -  Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical         MJX -  Kit, Serological, Positive Control         MJY -  Kit, Serological, Negative Control         MJZ -  Kit, Direct Antigen, Positive Control         MKA -  Kit, Direct Antigen, Negative Control       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     GIM -  Tubes, Vacuum Sample, With Anticoagulant   Pilot     GJE -  Tray, Blood Collection   Pilot     JKA -  Tubes, Vials, Systems, Serum Separators, Blood Collection   Pilot   862.1680 TESTOSTERONE TEST SYSTEM I    General Guidance   CDZ -  Radioimmunoassay, Testosterones And Dihydrotestosterone       862.1685 THYROXINE-BINDING GLOBULIN TEST SYSTEM II     CEE -  Radioimmunoassay, Thyroxine-Binding Globulin   Pilot   862.1690 THYROID-STIMULATING HORMONE TEST SYSTEM II     JLW -  Radioimmunoassay, Thyroid-Stimulating Hormone   Pilot   862.1695 FREE THYROXINE TEST SYSTEM II     CEC -  Radioimmunoassay, Free Thyroxine   Pilot   862.1700 TOTAL THYROXINE TEST SYSTEM II     CDX -  Radioimmunoassay, Total Thyroxine   Pilot     KLI -  Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine   Pilot   862.1730 FREE TYROSINE TEST SYSTEM I    General Guidance   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    General Guidance   CDH -  Acid, Uric, Phosphotungstate Reduction         CDO -  Acid, Uric, Uricase (U.V.)         JHA -  Acid, Uric, Uricase (Gasometric)         JHC -  Acid, Uric, Uricase (Oxygen Rate)         KNK -  Acid, Uric, Uricase (Colorimetric)         LFQ -  Acid, Uric, Acid Reduction Of Ferric Ion       862.1810 VITAMIN B12 TEST SYSTEMS II     CDD -  Radioassay, Vitamin B12   Pilot     LIG -  Radioassay, Intrinsic Factor Blocking Antibody   Pilot   862.1825 VITAMIN D TEST SYTEM II     MRG -  System, Test, Vitamin D   Pilot   862.2250 GAS LIQUID CHROMATOGRAPHY SYSTEM FOR CLINICAL USE I     JXQ -  Monitor, U.V., Glc   Pilot