21 CFR 862.1660
§ 862.1660 Quality control material (assayed and unassayed).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1660, § 862.1660 Quality control material (assayed and unassayed), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89180
- Permanent ID
ys:prov:89180@1- SHA-256
39ea3d8592981005840c7e57a3eaf1572d646a07cccc55ad715a97317442949b
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.