Model 100 Portable Clinical Analyzer and Test Pack

• • Terminated Z-1540-2009 FDA Unclassified (pre-2012) ·initiated 23 Feb 2009 ·via K894914, on the same 510(k)

  Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

• 4 recalls, same reason

  • Terminated Z-0372-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0375-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0371-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0374-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007

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

• • Terminated Z-1171-06 FDA Unclassified (pre-2012) ·initiated 24 May 2006

  Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained

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

510(k) Number

K894914 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

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

• 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

• I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control Set

  Class I

  FDA 510(k) K031873 Active Cleared 7 Oct 2003

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