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 862.3680](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3680) → DJD — Enzyme Immunoassay, Primidone

# DJD · Enzyme Immunoassay, Primidone

_Clinical Toxicology · 21 CFR 862.3680 · Class 2_

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

## Overview

- **Product Code:** DJD
- **Device Name:** Enzyme Immunoassay, Primidone
- **Regulation:** [21 CFR 862.3680](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3680)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K973582](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K973582.md) | ACE PRIMIDONE REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | Nov 12, 1997 | SESE |
| [K910527](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K910527.md) | EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE | Syva Co. | Mar 14, 1991 | SESE |
| [K840939](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K840939.md) | EMIT QST PRIMIDONE ASSAY | Syva Co. | Apr 24, 1984 | SESE |
| [K832798](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K832798.md) | MODIFICA-OF EMIT AED PRIMIDONE ASSAY | Syva Co. | Oct 14, 1983 | SESE |
| [K820138](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K820138.md) | PRIMIDONE REAGENT TEST KIT | Beckman Instruments, Inc. | Jan 28, 1982 | SESE |
| [K813597](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K813597.md) | TDX PRIMIDONE | Abbott Laboratories | Jan 22, 1982 | SESE |
| [K802654](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K802654.md) | AMES TDA PRIMIDONE TEST | Miles Laboratories, Inc. | Nov 12, 1980 | SESE |
| [K781957](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DJD/K781957.md) | ANALYTICAL TEST PACK, PRIMIDONE | E.I. Dupont DE Nemours & Co., Inc. | Jan 10, 1979 | SESE |

## Top Applicants

- Syva Co. — 3 clearances
- Abbott Laboratories — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance

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

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