Immulite Turbo Troponin I, Models LSKTI1, LSKTI5

• • Terminated Z-0801-2015 FDA Class II ·initiated 27 Oct 2014

510(k) Number

K991795 ↗

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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• What is the Immulite Turbo Troponin I assay used for?

  This device is an in vitro diagnostic assay designed to measure troponin I levels in patient samples. It is intended for professional use to assist in clinical chemistry assessments.

• Which sample types are compatible with this assay?

  The assay is validated for use with patient serum, heparinized plasma, or EDTA plasma samples when processed through the Immulite Automated Analyzer.

• What technology does this device use to measure troponin?

  The device utilizes a solid-phase, two-site chemiluminescent enzyme immunometric assay principle. This method is designed for the quantitative detection of the troponin subunit.

• Is this device cleared for clinical use?

  Yes, the Immulite Turbo Troponin I, including models LSKTI1 and LSKTI5, has received FDA 510(k) clearance as a Class II immunoassay method under regulation number 862.1215.