Recognized Consensus Standards

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New Search Back To Search Results Recognition List Number: 010 Publication Date: 06/01/2004  Part B: SUPPLEMENTARY INFORMATION Recognition Number 7-100: ISO 15197, In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus, First Edition 2003-05-01, Approved. (InVitro Diagnostics) Date of Standard: 2003.  Address of Standards Organization:   INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)*   1, RUE DE VAREMBE   CASE POSTALE 56   CH 1211 GENEVA 20,   SWITZERLAND CDRH Office and Division Associated with Recognized Standards: OFFICE OF IN VITRO DIAGNOSTIC DEVICE EVALUATION AND SAFETY (OIVD) DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD) Devices Affected: IN VITRO DIAGNOSTIC DEVICES FOR THE MEASUREMENT OF GLUCOSE Processes Affected: 510(K), PMA, PDP, IDE Extent of Recognition: Complete standard Related CFR Citations and Product Codes: Regulation Number Device Name Device Class Product Code §862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR §862.1345 Glucose Oxidase, Glucose Class 2 CGA §862.1345 Hexokinase, Glucose Class 2 CFR §862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW   Relevant Guidance: There is no relevant guidance developed at this time. FDA Technical Contact:   Patricia Bernhardt   FDA/CDRH/OIVD   2098 GAITHER ROAD, HFZ-440   ROCKIVLLE, MD 20850   240/276-0397   Email: patricia.bernhardt@fda.hhs.gov * In the United States, copies of this standard can be obtained from:   AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI)*   11 WEST 42ND STREET   NEW YORK, NY 10036