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CLINIQA® Liquid QC™ Assayed General Chemistry Control is intended for use as an assayed quality control material for the contituents listed in this package insert.

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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for "Cliniqa Liquid QC Assayed and Unassayed General Chemistry Control Levels 1, 2 & 3." It confirms that the device is substantially equivalent to legally marketed predicate devices.

While it mentions "indications for use," it does not include details about:

• Specific acceptance criteria (table form or otherwise)
• Reported device performance metrics
• Sample sizes for test sets or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies or effect sizes
• Standalone algorithm performance
• Types of ground truth used or how ground truth was established

This document is a regulatory approval notice, not a study report detailing performance data.

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