(543 days)
This assayed human serum pool is designed for use as a high control fluid to be used in conjunction with the Binding Site MININEPH® range of pro
Not Found
The document provided is a 510(k) clearance letter from the FDA for two control serum reference preparations. It does not contain information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any details about AI algorithms, ground truth, or statistical analyses typically associated with such studies.
Therefore, I cannot provide the requested information based on the given text. The document is strictly a regulatory approval notice for a medical 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.