(9 days)
The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Not Found
I am sorry, but the provided text from the FDA letter [K982845](https://510k.innolitics.com/search/K982845) only contains information about the regulatory approval of a device called "Cardiac Markers Control (Single Use) Levels 1,2,3". It states that the device is substantially equivalent to previously marketed devices and is for quality control purposes, specifically "to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation."
However, the document does not contain any information regarding acceptance criteria, device performance data from a study, sample sizes (for test or training sets), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
Therefore, I cannot provide an answer to your request based on the given input.
§ 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.