LAN · Enzyme Immunoassay, N-Acetylprocainamide
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | LAN |
|---|---|
| Device Name | Enzyme Immunoassay, N-Acetylprocainamide |
| Regulation | 21 CFR 862.3320 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060738 | TDM N-ACETYLPROCAINAMIDE | Roche Diagnostics Corp. | Aug 16, 2006 | SESE |
| K032564 | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 | Dade Behring, Inc. | Oct 31, 2003 | SESE |
| K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | Syva Co., Dade Behring, Inc. | Jun 18, 2001 | SESE |
| K983812 | NAPA EIA ASSAY | Diagnostic Reagents, Inc. | Nov 16, 1998 | SESE |
| K971713 | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | Jun 11, 1997 | SESE |
| K955422 | AXSYM N-ACETYLPROCAINAMIDE | Abbott Laboratories | Apr 24, 1996 | SESE |
| K934705 | OPUS NAPA | Pb Diagnostic Systems, Inc. | Nov 22, 1993 | SESE |
| K922915 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT | Syva Co. | Aug 24, 1992 | SESE |
| K895571 | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT | Tudor Laboratories, Inc. | Oct 25, 1989 | SESE |
| K873349 | EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 | Em Diagnostic Systems, Inc. | Sep 22, 1987 | SESE |
| K871680 | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR | Roche Diagnostic Systems, Inc. | Jun 8, 1987 | SESE |
| K860140 | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. | American Dade | Feb 6, 1986 | SESE |
| K853547 | STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I | American Dade | Sep 16, 1985 | SESE |
| K852319 | COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS | Roche Diagnostic Systems, Inc. | Jun 25, 1985 | SESE |
| K851060 | EMIT QST N-ACETYLPROCAINAMIDE ASSAY | Syva Co. | Apr 5, 1985 | SESE |
| K833378 | N-ACETYLPROCAINAMIDE ACA-ANALYTICAL | E.I. Dupont DE Nemours & Co., Inc. | Dec 27, 1983 | SESE |
| K832098 | N-ACETYLPROCAINAMIDE ASSAY FOR COBAS | Syva Co. | Aug 12, 1983 | SESE |
| K831399 | AMES TDA N-ACETYL-PROCAINAMIDE TEST | Miles Laboratories, Inc. | Jun 2, 1983 | SESE |
| K830206 | TDX N-ACETYLPROCAINAMIDE | Abbott Laboratories | Feb 18, 1983 | SESE |
| K823129 | ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE | Syva Co. | Nov 29, 1982 | SESE |
Top Applicants
- Syva Co. — 5 clearances
- Abbott Laboratories — 2 clearances
- American Dade — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- Bayer Corp. — 1 clearance
