(18 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.
CARDIAC MARKERS CONTROL (THREE LEVELS)
I am sorry, but the provided text is a 510(k) clearance letter for "Cardiac Markers Control Levels 1, 2, and 3". This letter acknowledges that the device is substantially equivalent to a predicate device and can be marketed.
However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies.
The letter focuses on regulatory approval and mentions "control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations," which refers to the purpose of the control material, not a study evaluating the control material itself.
§ 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.