KXT · Enzyme Immunoassay, Digoxin
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | KXT |
|---|---|
| Device Name | Enzyme Immunoassay, Digoxin |
| 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 85)
Showing 20 most recent of 85 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193397 | ADVIA Centaur® Digoxin assay | Siemens Healthcare Diagnostics, Inc. | Jul 16, 2021 | SESE |
| K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II | Roche Diagnostics | Apr 8, 2016 | SESE |
| K102346 | RANDOX DIGOXIN ASSAY | Randox Laboratories, Ltd. | Oct 14, 2011 | SESE |
| K093441 | DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 | Siemens Healthcare Diagnostics | Apr 7, 2010 | SESE |
| K082953 | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 | Biokit, S.A. | Dec 22, 2008 | SESE |
| K061249 | AXSYM DIGOXIN III | Abbott Laboratories | Jun 2, 2006 | SESE |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | Nov 14, 2003 | SESE |
| K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM | Seradyn | Oct 24, 2002 | SESE |
| K012301 | IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) | Diagnostic Products Corp. | Sep 19, 2001 | SESE |
| K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 | Syva Co., Dade Behring, Inc. | Jul 2, 2001 | SESE |
| K011302 | RANDOX DIGOXIN | Randox Laboratories, Ltd. | Jul 2, 2001 | SESE |
| K983323 | DIGOXIN IMMUNOASSAY | Diagnostic Reagents, Inc. | Nov 12, 1998 | SESE |
| K983151 | IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT | Beckman Coulter, Inc. | Nov 5, 1998 | SESE |
| K982935 | SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR | Beckman Coulter, Inc. | Oct 14, 1998 | SESE |
| K980521 | DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS | Bayer Corp. | Apr 2, 1998 | SESE |
| K973112 | ELECSYS DIGOXIN | Boehringer Mannheim Corp. | Oct 10, 1997 | SESE |
| K972794 | DIGOXIN DG-II FPIA REAGENT SET | Sigma Diagnostics, Inc. | Jul 31, 1997 | SESE |
| K970883 | CEDIA DIGOXIN II | Boehringer Mannheim Corp. | May 21, 1997 | SESE |
| K970881 | CEDIA DIGOXIN | Boehringer Mannheim Corp. | May 14, 1997 | SESE |
| K963062 | IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 | Beckman Instruments, Inc. | Dec 13, 1996 | SESE |
Top Applicants
- Syva Co. — 10 clearances
- Microgenics Corp. — 9 clearances
- Abbott Laboratories — 5 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 5 clearances
- Boehringer Mannheim Corp. — 4 clearances
