MOJ · Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Clinical Toxicology · 21 CFR 862.3350 · Class 2
Overview
| Product Code | MOJ |
|---|---|
| Device Name | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics | Mar 30, 2023 | SESE |
| K952555 | COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS | Roche Diagnostic Systems, Inc. | Jul 31, 1995 | SESE |
| K950280 | TDX(R)/TDXFLX(R) FREE PHENYTOIN II | Abbott Laboratories | May 2, 1995 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Roche Diagnostic Systems, Inc. — 1 clearance
- Roche Diagnostics — 1 clearance
