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) → MOJ — Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

# MOJ · Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

_Clinical Toxicology · 21 CFR 862.3350 · Class 2_

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

## Overview

- **Product Code:** MOJ
- **Device Name:** Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K230161](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MOJ/K230161.md) | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics | Mar 30, 2023 | SESE |
| [K952555](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MOJ/K952555.md) | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS | Roche Diagnostic Systems, Inc. | Jul 31, 1995 | SESE |
| [K950280](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/MOJ/K950280.md) | TDX(R)/TDXFLX(R) FREE PHENYTOIN II | Abbott Laboratories | May 2, 1995 | SESE |

## Top Applicants

- Abbott Laboratories — 1 clearance
- Roche Diagnostic Systems, Inc. — 1 clearance
- Roche Diagnostics — 1 clearance

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

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