(19 days)
Liquichek Serum Volatiles 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 Serum Volatiles Control is prepared from human serum with added constituents of human origin, pure chemicals, and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device called "Liquichek Serum Volatiles Control," focusing on its intended use, description, and comparison to a predicate device for substantial equivalence determination by the FDA. It does not include specific performance metrics, test methodologies, or study results typically associated with device performance validation.
Therefore, I cannot provide the requested information in the specified format.
§ 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.