21 CFR § 862.3680 - Primidone test system.

---
identifier: "/us/cfr/t21/s862.3680"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3680 - Primidone test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3680"
section_name: "Primidone test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.3680 Primidone test system.

(a) *Identification.* A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.

(b) *Classification.* Class II.