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New Search Back To Search Results Recognition List Number: 016 Publication Date: 11/03/2006  Part B: SUPPLEMENTARY INFORMATION Recognition Number 7-4: CLSI / NCCLS GP14-A 1996, Labeling of Home-Use In Vitro Testing Products; Approved Guideline. (InVitro Diagnostics) Date of Standard: 1996.  Addresses of Standards Organizations:   CLINICAL LABORATORY STANDARDS INSTITUTE (CLSI)   940 WEST VALLEY ROAD   SUITE 1400   WAYNE, PA 19087     NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS (NCCLS)   940 WEST VALLEY ROAD   SUITE 1400   WAYNE, PA 19087   CDRH Offices and Divisions Associated with Recognized Standards: (1) OFFICE OF DEVICE EVALUATION (ODE) DIVISION OF CLINICAL LABORATORY DEVICES (DCLD) (2) OFFICE OF COMPLIANCE (OC) Devices Affected: Home Use IVD's Processes Affected: Manufacturing/Devices Evaluation (510(k), PMA, PDP, IDE) Type of Standard:  National, Horizontal Extent of Recognition: Complete standard Related CFR Citations and Product Codes: Regulation Number Device Name Device Class Product Code §862.1115 Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Class 1 JJB   Regulation Number Device Name Device Class Product Code §862.1155 Agglutination Method, Human Chorionic Gonadotropin Class 2 JHJ §862.1155 Kit, Test, Pregnancy, Hcg, Over The Counter Class 2 LCX §862.1155 Radioimmunoassay, Human Chorionic Gonadotropin Class 2 JHI   Regulation Number Device Name Device Class Product Code §862.1170 Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride Class 2 CHK   Regulation Number Device Name Device Class Product Code §862.1175 Enzymatic Esterase--Oxidase, Cholesterol Class 1 CHH   Regulation Number Device Name Device Class Product Code §862.1340 Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Class 2 JIL   Regulation Number Device Name Device Class Product Code §862.1345 Glucose Oxidase, Glucose Class 2 CGA §862.1345 Hexokinase, Glucose Class 2 CFR   Regulation Number Device Name Device Class Product Code §862.1435 Nitroprusside, Ketones (Urinary, Non-Quant.) Class 1 JIN   Regulation Number Device Name Device Class Product Code §862.1485 Radioimmunoassay, Luteinizing Hormone Class 1 CEP   Regulation Number Device Name Device Class Product Code §862.1510 Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Class 1 JMT   Regulation Number Device Name Device Class Product Code §862.1550 Dye-Indicator, Ph (Urinary, Non-Quant.) Class 1 CEN   Regulation Number Device Name Device Class Product Code §862.1645 Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Class 1 JIR   Regulation Number Device Name Device Class Product Code §862.1785 Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Class 1 CDM   Regulation Number Device Name Device Class Product Code §862.2300 Colorimeter, Photometer, Spectrophotometer For Clinical Use Class 1 JJQ   Regulation Number Device Name Device Class Product Code §864.6550 Blood, Occult, Colorimetric, In Urine Class 2 JIO §864.6550 Reagent, Occult Blood Class 2 KHE   Regulation Number Device Name Device Class Product Code §864.7470 Assay, Glycosylated Hemoglobin Class 2 LCP   Regulation Number Device Name Device Class Product Code §866.2900 Device, Specimen Collection Class 1 LIO   Relevant Guidance: Review Criteria for Assessment of Over-The-Counter Human Chorionic Gonadotropin (HCG) In Vitro Diagnostic Devices. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians Office Laboratories, and Home Use. Points to Consider for Approval of Home Drugs of Abuse Test Kits. Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices FDA Technical Contact:   Arleen Pinkos   FDA/CDRH/OIVD   2098 GAITHER ROAD, HFZ-440   ROCKVILLE MD 20850   240/276-0490   Email: arleen.pinkos@fda.hhs.gov