(12 days)
Liquichek immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Immunology Control is prepared from human serum with added serum proteins and stabilizers. The control is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
The provided document is a 510(k) summary for the Bio-Rad Liquichek Immunology Control. It describes the device, its intended use, and claims substantial equivalence to an existing device. However, it does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics such as sensitivity, specificity, or accuracy that would be derived from a performance study.
Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on regulatory submission and demonstrating equivalence based on technological characteristics rather than providing performance study results.
§ 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.