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 862.3350](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3350) → LES — Fluorescent Immunoassay, Diphenylhydantoin

# LES · Fluorescent Immunoassay, Diphenylhydantoin

_Clinical Toxicology · 21 CFR 862.3350 · Class 2_

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

## Overview

- **Product Code:** LES
- **Device Name:** Fluorescent Immunoassay, Diphenylhydantoin
- **Regulation:** [21 CFR 862.3350](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3350)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

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

## Classification Rationale

Class II.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K865102](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K865102.md) | IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS | Sclavo, Inc. | Jan 13, 1987 | SESE |
| [K844990](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K844990.md) | SYVA ADVANCE EMIT PHENYTOIN ASSAY | Syva Co. | Jan 23, 1985 | SESE |
| [K831154](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K831154.md) | STRATUS PHENYTOIN FLUOROMETRIC ENZYME | American Dade | May 16, 1983 | SESE |
| [K820187](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K820187.md) | SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY | Syva Co. | Feb 12, 1982 | SESE |
| [K813538](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K813538.md) | PHENYTOIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Dec 31, 1981 | SESE |
| [K811025](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K811025.md) | AMES TDA TM PHENYTOIN TEST | Miles Laboratories, Inc. | Apr 29, 1981 | SESE |
| [K801736](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LES/K801736.md) | AMES TDA TM PHENYTOIN TEST | Miles Laboratories, Inc. | Aug 20, 1980 | SESE |

## Top Applicants

- Miles Laboratories, Inc. — 2 clearances
- Syva Co. — 2 clearances
- American Dade — 1 clearance
- American Diagnostic Corp. — 1 clearance
- Sclavo, Inc. — 1 clearance

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

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