OTF · Gabapentin Assay
Clinical Toxicology · 21 CFR 862.3350 · Class 2
Overview
| Product Code | OTF |
|---|---|
| Device Name | Gabapentin Assay |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101574 | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 | Ark Diagnostics, Inc. | Nov 23, 2010 | SESE |
Top Applicants
- Ark Diagnostics, Inc. — 1 clearance
