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CLINIQA® Liquid QC™ Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for uroud a standard.

LiniCAL Cardiac Marker Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product inert are provided to allow monitoring of the reportable range.

CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liguid QC Complete Cardiac Marker Control is not intended for use as a standard.

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This document is an FDA 510(k) clearance letter for three medical devices: "Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1, 2, and 3", "Cliniqa LiniCal Cardiac Marker Calibration Verifiers, Levels A-D", and "Cliniqa Liquid QC Cardiac Marker Control-Low".

The letter states that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed. However, the document does not contain information regarding acceptance criteria, study details, or performance data. It is a regulatory clearance document, not a study report.

Therefore, I cannot extract the requested information about acceptance criteria and the study that proves the device meets them from the provided text. The document is primarily focused on the regulatory approval for marketing the devices as quality control and calibration verification materials for cardiac markers.

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