(25 days)
The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.
The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.
This document is an FDA 510(k) clearance letter for the Randox Lipid Control, stating that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain any information about acceptance criteria or a study proving device performance related to a specific clinical outcome or diagnostic accuracy.
The device described is a "Quality Control Material" for clinical chemistry applications, specifically lipid monitoring. Its stated "Indications For Use" are: "The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume."
Therefore, I cannot provide the requested information from this document. The typical studies and criteria you've asked about (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are relevant to diagnostic devices or AI algorithms that provide clinical insights or diagnoses. This document pertains to a quality control material used to ensure the proper functioning of laboratory equipment.
§ 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.