Reflotron(R) Ast (Got)

• • Terminated Z-1302-04 FDA Unclassified (pre-2012) ·initiated 14 Jul 2004 ·on shared 510(k) K870246

  Coating defect may result is falsely decreased patient and/or control results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K870246 ↗

FDA Product Code

CIT

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Unimeter 330K

  Class II

  FDA 510(k) K822441 Active Cleared 8 Oct 1982

• Precinorm Hdl Cholesterol Control Material for Ref

  Class I

  FDA 510(k) K902569 Active Cleared 9 Aug 1990

• Precimat Glycerol

  Class I

  FDA 510(k) K780439 Active Cleared 18 Apr 1978

• Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844

  Class II

  FDA 510(k) K981883 Active Cleared 7 Jul 1998

• Stattek Bun

  Class II

  FDA 510(k) K792328 Active Cleared 18 Dec 1979

• Softtouch II Lancet Device

  Class II

  FDA 510(k) K931258 Active Cleared 10 Feb 1994

See all devices from Boehringer Mannheim Corp. →

• What is the REFLOTRON AST (GOT) device used for?

  The REFLOTRON AST (GOT) is a clinical chemistry device designed for measuring aspartate aminotransferase (AST), also known as glutamic oxaloacetic transaminase (GOT), in biological samples using the Nadh Oxidation/Nad Reduction method.

• Is the REFLOTRON AST (GOT) device sterile and reusable?

  The REFLOTRON AST (GOT) is supplied as a single-use, non-sterile instrument intended for use in clinical laboratories. It is not designed for reuse and should be handled according to manufacturer guidelines.

• What is the regulatory classification of the REFLOTRON AST (GOT)?

  The device is classified as a Class II medical device under 21 CFR 862.1100 and has received FDA 510(k) clearance (K870246) for substantial equivalence, meaning it is substantially equivalent to legally marketed devices.

• How should the REFLOTRON AST (GOT) be stored?

  The device requires proper storage and handling according to manufacturer guidelines to ensure accurate performance, though specific storage conditions are not detailed in the provided information.