(25 days)
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.
Not Found
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.
§ 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.