21 C.F.R. § 862.3280 Clinical toxicology control material.
Title 21 - Food and Drugs
(a) Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials. (b) Classification. Class I (general controls). Except when used in donor screening, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D—Clinical Toxicology Test Systems
§ 862.3280 Clinical toxicology control material.
