I-Stat System

• • Terminated Z-0456-2011 FDA Unclassified (pre-2012) ·initiated 17 Mar 2010

  The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.

• • Terminated Z-0373-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007 ·via K973292, on the same 510(k)

  Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K973292 ↗

FDA Product Code

CGL

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Modification to: I-Stat Portable Clinical Analyzer

  Class II

  FDA 510(k) K012478 Active Cleared 20 Aug 2001

• Model 100 Portable Clinical Analyzer and Test Pack

  Class II

  FDA 510(k) K894914 Active Cleared 16 Oct 1989

• I-Stat Control Levels 1, 2, 3

  Class I

  FDA 510(k) K934641 Active Cleared 9 Dec 1993

• I-Stat Tests for Acid-Base Parameters

  Class II

  FDA 510(k) K936081 Active Cleared 24 Feb 1994

• I-Stat B-Type Natriuretic Peptide (Bnp)

  Class II

  FDA 510(k) K053597 Active Cleared 21 Jul 2006

• I-Stat 200 Portable Clinical Analyzer Open recall

  Class II

  FDA 510(k) K940918 Active Cleared 10 May 1994

See all devices from I-Stat Corp. →