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) → LGR — Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

# LGR · Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

_Clinical Toxicology · 21 CFR 862.3350 · Class 2_

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

## Overview

- **Product Code:** LGR
- **Device Name:** Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
- **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 (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K955873](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K955873.md) | ACS PHENYTOIN ASSAY | Ciba Corning Diagnostics Corp. | Mar 11, 1996 | SESE |
| [K955562](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K955562.md) | INNOFLUOR PHENYTOIN ASSAY SYSTEM | Oxis Intl., Inc. | Jan 24, 1996 | SESE |
| [K953840](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K953840.md) | AXSYM PHENYTOIN II | Abbott Laboratories | Sep 25, 1995 | SESE |
| [K946328](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K946328.md) | TDX(R)/TDXFLX(R) PHENYTOIN II | Abbott Laboratories | Mar 28, 1995 | SESE |
| [K943313](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K943313.md) | PHENYTOIN FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | Oct 27, 1994 | SESE |
| [K935375](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K935375.md) | AXSYM PHENYTOIN ASSAY | Abbott Laboratories | Jun 21, 1994 | SESE |
| [K936131](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K936131.md) | COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS | Roche Diagnostic Systems, Inc. | Mar 11, 1994 | SESE |
| [K896868](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K896868.md) | OPUS PHENYTOIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | Jan 2, 1990 | SESE |
| [K895827](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K895827.md) | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET | Innotron of Oregon, Inc. | Oct 31, 1989 | SESE |
| [K872563](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K872563.md) | INNOTRON INNOFLUOR PHEYTOIN REAGENT SET | Innotron of Oregon, Inc. | Aug 21, 1987 | SESE |
| [K862554](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K862554.md) | IMMPULSE PHENYTOIN ASSAY REAGENT | Sclavo, Inc. | Jul 16, 1986 | SESE |
| [K843824](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K843824.md) | COBAS FP REAGENTS FOR PHENYTOIN & CALIBR | Roche Diagnostic Systems, Inc. | Feb 1, 1985 | SESE |
| [K844171](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K844171.md) | PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 10, 1984 | SESE |
| [K842586](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K842586.md) | PHENYTOIN KIT FLUORESCENCE POLARIZATION | Windsor Laboratories, Inc. | Sep 26, 1984 | SESE |
| [K841706](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K841706.md) | INNOFLUOR PHENYTOIN | Innotron Diagnostics | May 22, 1984 | SESE |

## Top Applicants

- Abbott Laboratories — 3 clearances
- Innotron of Oregon, Inc. — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Ciba Corning Diagnostics Corp. — 1 clearance

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

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