(50 days)
NOVA-ONE Control is intended for use in the laboratory to monitor the accuracy and rrovit one of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.
NOVA-ONE Lipid Control Human Liquid Lipid Control
This document is an FDA 510(k) clearance letter for a quality control material (NOVA-ONE Lipid Control Human Liquid Lipid Control). It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical AI/imaging devices.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided text does not contain this type of data. The letter simply states that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory determination for a quality control material and not a performance study as described in your request.
§ 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.