(59 days)
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.
Not Found
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.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.