(22 days)
CLINIQA Liquid-QC™ hCG Control is intended for use as an assayed quality control material for serum Human Chorionic Gonadotropin protein analysis, which is used to monitor the accuracy and precision of procedures in use in the clinical laboratory.
CLINIQA Liquid-QC™ hCG Control Levels 1, CLINIQA Liquid-QC™ hCG Control Levels 2, CLINIQA Liquid-QC™ hCG Control Levels 3
The provided text is a 510(k) premarket notification letter from the FDA regarding CLINIQA Liquid-QC™ hCG Control Levels 1, 2, and 3. This document confirms the substantial equivalence of the device to a predicate device and allows it to be marketed.
However, the letter does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study report proving a device meets acceptance criteria.
This type of FDA letter is an administrative approval based on the device being "substantially equivalent" to an already legally marketed device (the "predicate device"). It means the new device has the same intended use and technological characteristics as the predicate, or if it has different characteristics, these do not raise new questions of safety and effectiveness. The detail about performance criteria and specific studies demonstrating those criteria are typically found in the 510(k) submission itself, not in the FDA's decision letter.
Therefore, I cannot provide the requested table and study details based solely on the provided text. The document is about the regulatory approval, not the detailed performance 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.