I-Stat Prothrombin Time Test

• • Terminated Z-2361-2015 FDA Class II ·initiated 15 Jun 2015

  Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.

• • Terminated Z-0451-2014 FDA Class II ·initiated 28 Oct 2013

  Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.

• • Terminated Z-2157-2012 FDA Class II ·initiated 1 Mar 2012

  The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.

• • Terminated Z-1996-2010 FDA Unclassified (pre-2012) ·initiated 5 May 2010

  A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.

• • Terminated Z-0364-2007 FDA Unclassified (pre-2012) ·initiated 12 Dec 2006

  Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.

510(k) Number

K020355 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

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

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