(31 days)
The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.
The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin.
The provided text is a 510(k) summary for a medical device called "MSC Lipid Control," which is a quality control material for clinical laboratory analysis of lipids. It does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used for AI-driven devices.
This document describes a traditional medical device (a control material) and its substantial equivalence to a predicate device, rather than a novel device requiring extensive performance studies with AI or human readers. Therefore, the requested information elements are not applicable to the provided context.
§ 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.