Triage Cardio Profiler/Triage Cardiac Panel

• • Ongoing Z-1974-2023 FDA Class I ·initiated 25 May 2023 ·on shared 510(k) K030286

  Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis.

• • Terminated Z-1929-2012 FDA Class I ·initiated 22 May 2012

  Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.

• • Terminated Z-1391-2009 FDA Unclassified (pre-2012) ·initiated 27 Apr 2009 ·on shared 510(k) K030286

  The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K030286 ↗

FDA Product Code

NBC

Device Class

Class II

Regulation

21 CFR Part 862.1117

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Biosite Triage Panel For Drugs Of Abuse (50NG/ML)

  Class II

  FDA 510(k) K931598 Active Cleared 12 May 1993

• Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I

  Class II

  FDA 510(k) K973126 Active Cleared 6 Oct 1997

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  Class II

  FDA 510(k) K032235 Active Cleared 28 Jan 2004

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  FDA 510(k) K092048 Active Cleared 19 Apr 2010

• Biosite Diagnostics Opiate Screening Test

  Class II

  FDA 510(k) K902924 Active Cleared 14 Sep 1990

• Triage Tox Drug Screen, Catalog #94000

  Class II

  FDA 510(k) K012745 Active Cleared 10 Jan 2002

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