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CLINIQA Liquid QC Cardiac Marker Control SP, Levels 1, 2, & 3 are intended for use as assayed quality control material for CK-MB, hs-CRP, Digoxin, Myoglobin, cTnl, Troponin T, and NT ProBNP analysis.

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This document is an FDA 510(k) clearance letter for a medical device called "CLINIQA Liquid QC™ Cardiac Marker Control SP Levels 1, 2, & 3". It grants permission to market the device based on its substantial equivalence to a predicate device.

However, this letter does not contain information about the acceptance criteria and the study that proves the device meets those criteria, nor any of the specific details requested in the bullet points (sample sizes, expert qualifications, adjudication methods, multi-reader studies, standalone performance, ground truth types, or training set details).

The letter simply states that the device is "intended for use as assayed quality control material for CK-MB, hs-CRP, Digoxin, Myoglobin, cTnl, Troponin T, and NT ProBNP analysis." It does not provide any performance data or study results to elaborate on how this intended use is achieved or how the device's accuracy or effectiveness was evaluated.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document is an administrative clearance, not a performance study report.

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