NWM · Immunoassay, Anti-Seizure Drug
Clinical Toxicology · 21 CFR 862.3350 · Class 2
Overview
| Product Code | NWM |
|---|---|
| Device Name | Immunoassay, Anti-Seizure Drug |
| Regulation | 21 CFR 862.3350 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | Aug 5, 2021 | SESE |
| K091884 | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 | Ark Diagnostics, Inc. | Dec 9, 2009 | SESE |
| K083799 | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 | Ark Diagnostics, Inc. | Apr 16, 2009 | SESE |
| K070645 | SERADYN QMS TOPIRAMATE | Seradyn, Inc. | May 17, 2007 | SESE |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Seradyn, Inc. | Nov 18, 2005 | SESE |
Top Applicants
- Ark Diagnostics, Inc. — 3 clearances
- Seradyn, Inc. — 2 clearances
