Roche Cobas Integra Reagent Cassettes & Ancillary Reagents

• • Terminated Z-0688-2008 FDA Unclassified (pre-2012) ·initiated 3 Dec 2007

  False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.

510(k) Number

K972250 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Abuscreen(R) Radioimmun for Cocaine Metabolite

  Class II

  FDA 510(k) K913722 Active Cleared 10 Sep 1991

• Cobas Core Immunochemistry System

  Class I

  FDA 510(k) K962231 Active Cleared 30 Aug 1996

• Roche Reagent for Apolipoprotein B

  Class I

  FDA 510(k) K910552 Active Cleared 7 May 1991

• Roche Unimate 3/Unimate 5 HBA1C, HBA1C Calibrator, HBA1C Controls N & P

  Class II

  FDA 510(k) K952337 Active Cleared 9 Feb 1996

• Roche Abuscreen Ontrak Pos. Ref. Control-Methadone

  Class I

  FDA 510(k) K930844 Active Cleared 27 Jan 1994

• Ontrak Testcup Amphetamines

  Class II

  FDA 510(k) K962411 Active Cleared 7 Oct 1996

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