21 C.F.R. § 862.1660

Current through April 30, 2024
Section 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 .

21 C.F.R. §862.1660

52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000, 84 FR 71796, Dec. 30, 2019
84 FR 71796, 12/30/2019