(20 days)
CLINIQA Liquid QC™ Tumor Marker Control for serum protein and tumor marker analysis is intended for use as an assayed quality control material for serum protein and tumor marker analysis
CLINIQA Liquid QC™ Tumor Marker Control Level 1 CLINIQA Liquid QC™ Tumor Marker Control Level 2 CLINIQA Liquid QC™ Tumor Marker Control Level 3 CLINIQA Liquid QCTM Tumor Marker Control, Tri-Level
This document is a 510(k) premarket notification from the FDA to Cliniqa Corporation regarding their CLINIQA Liquid QC™ Tumor Marker Control. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
The document does not contain any information about acceptance criteria, device performance, sample sizes used, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
The content is primarily a regulatory approval letter. Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.
§ 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.