Diagnostics

U.S. FDA grants market clearance for ischemia modified albumin test run on Roche analyzers

Published in Medical Letter on the CDC and FDA, January 29th, 2006

Inverness Medical Innovations, Inc. (IMA) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its albumin cobalt binding (ACB) test for detection of ischemia modified albumin (IMA) on the Roche Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems.

Shipments on those platforms will began during the first quarter of 2006. Inverness announced in July 2005 that its subsidiary Wampole Laboratories had signed an agreement with Roche Diagnostics Corporation to collaborate on the first fully automated diagnostic test for IMA to run on Roche's Integra chemistry analyzers and would begin sale of such tests upon...

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Source: Medical Letter on the CDC and FDA (2006-01-29)

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