(49 days)
Lyphochek Tumor Marker 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.
Lyphochek Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.
This document is a 510(k) summary for the Lyphochek Tumor Marker Control, a quality control serum used in laboratory testing. It does not contain information about acceptance criteria or a study proving device performance as it is not a diagnostic device that outputs a performance metric (e.g., accuracy, sensitivity, specificity).
Therefore, I cannot provide the requested information in the format specified. The document is a regulatory submission for a quality control product, not a clinical study on a diagnostic device.
§ 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.