I-Stat System

• • Terminated Z-1341-2011 FDA Unclassified (pre-2012) ·initiated 3 Dec 2010

  Celite ACT cartridges have increased numbers of values outside the accepted allowable error.

• • Terminated Z-0399-2011 FDA Unclassified (pre-2012) ·initiated 6 Oct 2010

  Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.

• • Terminated Z-0813-2010 FDA Unclassified (pre-2012) ·initiated 18 Aug 2009

  Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.

• • Terminated Z-0912-05 FDA Unclassified (pre-2012) ·initiated 16 Mar 2005

  Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.

510(k) Number

K992571 ↗

FDA Product Code

JBP

Device Class

Class II

Regulation

21 CFR Part 864.7140

Advisory Committee

Hematology

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. →