{"data":{"id":"us/21-cfr-862.3280","jurisdiction":"us","citation":"21 CFR 862.3280","heading":"Clinical toxicology control material.","body":"(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.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart D—Clinical Toxicology Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"9fb133767cbfea8b7299ab3d3e26d88344f4f4a9b77832c86301c28b471caea3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.3270","next":"us/21-cfr-862.3300"},"notice":"GroundRules: Original legal text. Not legal advice."}