(141 days)
CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the assaycu, liquid, quality control procuments an analytes listed in the product insert.
assayed, liquid, quality control products
The provided text is a 510(k) premarket notification letter from the FDA regarding the CLINIQA® Liquid QC™ Immunoassay Control. It confirms substantial equivalence to a predicate device and outlines regulatory compliance. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily an FDA clearance letter and lacks the technical details of a device study.
§ 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.