(119 days)
Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of a laboratory testing procedures for the analytes listed in this package insert.
Liquichek Immunoassay Plus Control is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.
This document is a 510(k) Summary for a quality control device called "Liquichek Immunoassay Plus Control." It does not describe an AI/ML powered medical device, an imaging device, or a device that would typically have acceptance criteria in the manner requested.
Therefore, I cannot provide a response filling out the requested information (acceptance criteria, study details, expert involvement, sample sizes, ground truth, etc.). This document is for a laboratory control product and focuses on its intended use, form, matrix, and storage, and compares it to a substantially equivalent 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.