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 862.3660](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3660) → LET — Fluorescent Immunoassay, Phenobarbital

# LET · Fluorescent Immunoassay, Phenobarbital

_Clinical Toxicology · 21 CFR 862.3660 · Class 2_

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

## Overview

- **Product Code:** LET
- **Device Name:** Fluorescent Immunoassay, Phenobarbital
- **Regulation:** [21 CFR 862.3660](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3660)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

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

## Classification Rationale

Class II.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K901537](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K901537.md) | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM | Pb Diagnostic Systems, Inc. | Jun 12, 1990 | SESE |
| [K865000](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K865000.md) | IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS | Sclavo, Inc. | Feb 6, 1987 | SESE |
| [K842592](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K842592.md) | AMES TDA PHENOBARBITAL TEST | Miles Laboratories, Inc. | Aug 17, 1984 | SESE |
| [K830701](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K830701.md) | STRATUS PHENOBARBITAL FLUOROMETRIC ENZ | American Dade | May 13, 1983 | SESE |
| [K821408](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K821408.md) | PHENOBARBITAL FLUORESCENT IMMUNO | American Diagnostic Corp. | May 24, 1982 | SESE |
| [K820188](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K820188.md) | PHENOBARBITAL ASSAY | Syva Co. | Feb 5, 1982 | SESE |
| [K810994](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K810994.md) | AMES TDA TM PHENOBARBITAL TEST | Miles Laboratories, Inc. | Apr 29, 1981 | SESE |
| [K802255](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K802255.md) | AMES TDA PHENOBARBITAL TEST | Miles Laboratories, Inc. | Sep 26, 1980 | SESE |

## Top Applicants

- Miles Laboratories, Inc. — 3 clearances
- American Dade — 1 clearance
- American Diagnostic Corp. — 1 clearance
- Pb Diagnostic Systems, Inc. — 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/LET](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET)

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