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) → DIP — Enzyme Immunoassay, Diphenylhydantoin

# DIP · Enzyme 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/DIP

## Overview

- **Product Code:** DIP
- **Device Name:** Enzyme 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 (20 of 44)

Showing 20 most recent of 44 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K080696](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K080696.md) | ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 | Abbott Laboratories | Sep 11, 2008 | SESE |
| [K063145](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K063145.md) | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS | Thermo Electron OY | Oct 17, 2007 | SESE |
| [K030428](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K030428.md) | ROCHE ONLINE TDM PHENYTOIN | Roche Diagnostics Corp. | Apr 28, 2003 | SESE |
| [K011393](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K011393.md) | RANDOX PHENYTOIN | Randox Laboratories, Ltd. | Dec 4, 2001 | SESE |
| [K011347](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K011347.md) | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | Syva Co. | May 17, 2001 | SESE |
| [K000006](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K000006.md) | IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 | Diagnostic Products Corp. | Feb 28, 2000 | SESE |
| [K993026](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K993026.md) | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS | Syva Co. | Jan 27, 2000 | SESE |
| [K973414](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K973414.md) | ACE PHENYTOIN REAGENT, AED CALIBRATORS | Schiapparelli Biosystems, Inc. | Nov 4, 1997 | SESE |
| [K963840](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K963840.md) | CEDIA PHENYTOIN II ASSAY | Boehringer Mannheim Corp. | Nov 20, 1996 | SESE |
| [K943980](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K943980.md) | IL TEST PHENYTION CALIBRATORS | Instrumentation Laboratory CO | May 1, 1995 | SESE |
| [K945725](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K945725.md) | PHENYTION EIA TEST | Diagnostic Reagents, Inc. | Feb 3, 1995 | SESE |
| [K944085](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K944085.md) | ACE(TM) CEDIA(R) PHENYTOIN ASSAY | Schiapparelli Biosystems, Inc. | Dec 28, 1994 | SESE |
| [K941142](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K941142.md) | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN | Eastman Kodak Company | Jun 13, 1994 | SESE |
| [K932686](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K932686.md) | PARAMAX(R) PHENYTOIN REAGENT | Baxter Diagnostics, Inc. | Nov 26, 1993 | SESE |
| [K915755](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K915755.md) | BIOTRACK PHENYTOIN TEST CARTRIDGE | Biotrack, Inc. | Jul 23, 1992 | SESE |
| [K913429](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K913429.md) | EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS | Syva Co. | Aug 26, 1991 | SESE |
| [K911056](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K911056.md) | DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Apr 3, 1991 | SESE |
| [K905689](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K905689.md) | CEDIA PHENYTOIN ASSAY | Microgenics Corp. | Jan 17, 1991 | SESE |
| [K904815](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K904815.md) | QMS TM- PHENYTOIN | Seradyn, Inc. | Nov 6, 1990 | SESE |
| [K902952](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K902952.md) | IL PHENYTOIN ASSAY SYSTEM | Instrumentation Laboratory CO | Aug 22, 1990 | SESE |

## Top Applicants

- Syva Co. — 10 clearances
- Abbott Laboratories — 4 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 3 clearances
- Em Diagnostic Systems, Inc. — 3 clearances
- Instrumentation Laboratory CO — 2 clearances

---

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

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