DLF · Enzyme Immunoassay, Ethosuximide
Clinical Toxicology · 21 CFR 862.3380 · Class 2
Overview
| Product Code | DLF |
|---|---|
| Device Name | Enzyme Immunoassay, Ethosuximide |
| Regulation | 21 CFR 862.3380 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
An ethosuximide test system is a device intended to measure ethosuximide, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring levels of ethosuximide to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K881607 | EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 | Em Diagnostic Systems, Inc. | Jun 1, 1988 | SESE |
| K850174 | TDX ETHOSUXIMIDE | Abbott Laboratories | Feb 6, 1985 | SESE |
| K844204 | EMIT QST ETHOSUXIMIDE ASSAY | Syva Co. | Dec 11, 1984 | SESE |
| K832797 | MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY | Syva Co. | Sep 29, 1983 | SESE |
| K823801 | AMES TDA ETHOSUXIMIDE TEST | Miles Laboratories, Inc. | Jan 14, 1983 | SESE |
| K823745 | ADVANCE EMIT-AED ETHOSUXIMIDE | Syva Co. | Jan 7, 1983 | SESE |
| K792584 | ACA ETHOSURIMIDE TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Dec 31, 1979 | SESE |
| K780461 | ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 | Syva Co. | Apr 12, 1978 | SESE |
| K780380 | ANALYZER, FAST, CENTRIFUGAL, GEMSAEC | Syva Co. | Apr 12, 1978 | SESE |
Top Applicants
- Syva Co. — 5 clearances
- Abbott Laboratories — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
