21 CFR § 862.3380 - Ethosuximide test system.

---
identifier: "/us/cfr/t21/s862.3380"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.3380 - Ethosuximide test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.3380"
section_name: "Ethosuximide 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"
---


# 862.3380 Ethosuximide test system.

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

(b) *Classification.* Class II.