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) → ORI — Levetiracetam Assay

# ORI · Levetiracetam Assay

_Clinical Toxicology · 21 CFR 862.3350 · Class 2_

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

## Overview

- **Product Code:** ORI
- **Device Name:** Levetiracetam Assay
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K232522](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/ORI/K232522.md) | ARK Levetiracetam II Assay | Ark Diagnostics, Inc. | Feb 27, 2024 | SESE |
| [K091653](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/ORI/K091653.md) | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 | Ark Diagnostics, Inc. | Nov 2, 2009 | SESE |

## Top Applicants

- Ark Diagnostics, Inc. — 2 clearances

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

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