Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3380](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3380) → DIY — Gas Chromatography, Ethosuximide

# DIY · Gas Chromatography, Ethosuximide

_Clinical Toxicology · 21 CFR 862.3380 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY

## Overview

- **Product Code:** DIY
- **Device Name:** Gas Chromatography, Ethosuximide
- **Regulation:** [21 CFR 862.3380](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3380)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K780734](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY/K780734.md) | ANTICONVULSANTS II CALIBRATOR KIT | Vitek Systems, Inc. | Jun 22, 1978 | SESE |

## Top Applicants

- Vitek Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIY)

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