(39 days)
The Wako Quality Control is intended for use as an assay quality maroations in of ooo. The transecision of laboratory testing procedures for the Wako Control scrain to monitor the processor of L-Cholesterol, LDL-Cholesterol, lipid assuy cash as Thigyonins, NEFA C, Free Cholesterol and beta Lipoprotein assays.
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I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving a device meets them.
The document is a 510(k) clearance letter from the FDA for a device called "Wako Lipid Control." This letter states that the device is substantially equivalent to legally marketed predicate devices. While it mentions the device's "Indications for Use" (as a quality control material for lipid assays), it does not include any acceptance criteria or details of a study that proves the device meets specific acceptance criteria.
The document is a regulatory approval, not a scientific study report.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
§ 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.