Vitros Immunodiagnostic Products Troponin I Reagent Pack and Calibrators

• • Terminated Z-0820-2007 FDA Unclassified (pre-2012) ·initiated 27 Apr 2007

  Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.

• • Terminated Z-1053-04 FDA Unclassified (pre-2012) ·initiated 7 Jun 2004

  Random occurrence of false positive test results.

510(k) Number

K031031 ↗

FDA Product Code

MMI

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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