KLR · Enzyme Immunoassay, Lidocaine
Clinical Toxicology · 21 CFR 862.3555 · Class 2
Overview
| Product Code | KLR |
|---|---|
| Device Name | Enzyme Immunoassay, Lidocaine |
| Regulation | 21 CFR 862.3555 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090282 | QMS LIDOCAINE | Thermo Fisher Scientific, Inc. | May 29, 2009 | SESE |
| K033809 | DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D | Dade Behring, Inc. | Feb 20, 2004 | SESE |
| K032334 | ROCHE ONLINE TDM LIDOCAINE | Roche Diagnostics Corp. | Jan 12, 2004 | SESE |
| K973102 | LIDOCAINE EIA ASSAY | Diagnostic Reagents, Inc. | Sep 12, 1997 | SESE |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | Diagnostic Systems | Jun 20, 1988 | SESE |
| K853010 | COBAS REAGENT FOR LIDOCAINE & CALIBRATORS | Roche Diagnostic Systems, Inc. | Aug 7, 1985 | SESE |
| K843184 | STRATUS LIDOCAINE FLUOROMETRIC ENZYME | American Dade | Sep 26, 1984 | SESE |
| K833381 | VALPROIC ACID ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Dec 27, 1983 | SESE |
| K833379 | LIDOCAINE ANALYTICAL TEST PACK ACA | E.I. Dupont DE Nemours & Co., Inc. | Dec 27, 1983 | SESE |
| K833623 | MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY | Syva Co. | Dec 8, 1983 | SESE |
| K832799 | MODIFICA- OF EMIT CAD LIDOCAINE ASSAY | Syva Co. | Oct 14, 1983 | SESE |
| K831354 | EMIT QST LIDOCAINE ASSAY | Syva Co. | May 27, 1983 | SESE |
| K823887 | ADVANCE EMIT CAD DISOPYRAMIDE ASSAY | Syva Co. | Jan 28, 1983 | SESE |
| K823866 | ADVANCE EMIT CAD LIDOCAINE ASSAY | Syva Co. | Jan 12, 1983 | SESE |
| K822347 | LIDOCAINE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Aug 25, 1982 | SESE |
| K802131 | CYBREX LIDOCAINE | Abbott Laboratories | Oct 31, 1980 | SESE |
| K801204 | EMIT DISOPYRAMIDE ASSAY | Syva Co. | Jun 9, 1980 | SESE |
Top Applicants
- Syva Co. — 6 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- American Dade — 1 clearance
- American Diagnostic Corp. — 1 clearance
