LFT · Fluorescent Immunoassay, Primidone
Clinical Toxicology · 21 CFR 862.3680 · Class 2
Overview
| Product Code | LFT |
|---|---|
| Device Name | Fluorescent Immunoassay, Primidone |
| Regulation | 21 CFR 862.3680 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950028 | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | Mar 21, 1995 | SESE |
| K904683 | STRATUS PRIMIDONE FLUOROMETRIC ENZYME | Baxter Healthcare Corp | Nov 28, 1990 | SESE |
| K895567 | PRIMIDONE (FPIA) KIT | Tudor Laboratories, Inc. | Oct 20, 1989 | SESE |
| K852318 | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS | Roche Diagnostic Systems, Inc. | Jun 25, 1985 | SESE |
| K842196 | STRATUS PRIMIDONE FLOROMETRIC ENZY | American Dade | Jul 11, 1984 | SESE |
| K823741 | ADVANCE EMIT-AED PRIMEDONE ASSAY | Syva Co. | Jan 7, 1983 | SESE |
| K822229 | PRIMIDONE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Aug 12, 1982 | SESE |
| K811007 | AMES TDA TM PRIMIDONE TEST | Miles Laboratories, Inc. | Apr 29, 1981 | SESE |
Top Applicants
- American Dade — 1 clearance
- American Diagnostic Corp. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Roche Diagnostic Systems, Inc. — 1 clearance
