part_subject: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
subpart_code: "D"
subpart_subject: "Clinical Toxicology Test Systems"
section_number: "862.3280"
section_subject: "Clinical toxicology control material."
cfr_reference: "21 CFR 862.3280"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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.