Enzyme Immunoassay, Digoxin
FDA product code KXT · Class II (moderate risk) · 21 CFR 862.3320 · Clinical Toxicology
85510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Syva Co. 10
- Microgenics Corp. 9
- Abbott Laboratories 5
- E.I. Dupont DE Nemours & Co., Inc. 5
- Boehringer Mannheim Corp. 4
- Instrumentation Laboratory CO 3
- Sigma Diagnostics, Inc. 3
- Beckman Instruments, Inc. 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Siemens Healthcare Diagnostics, Inc. 2
- Diagnostic Reagents, Inc. 2
- Randox Laboratories, Ltd. 2
- Beckman Coulter Inc. 2
- Immunotech Corp. 2
- Organon, Inc. 2
- Roche Diagnostic Systems, Inc. 1
- V-Tech, Inc. 1
- Aktis Corp. 1
- Roche Diagnostics Corp. 1
- Vxr, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193397 | ADVIA Centaur® Digoxin assayKXT · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/16/2021SE |
| K153301 | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIKXT · Traditional | Roche Diagnostics | 04/08/2016SE |
| K102346 | Randox Digoxin AssayKXT · Traditional | Randox Laboratories, Ltd. | 10/14/2011SE |
| K093441 | Dimension Vista Loci Digoxin Flex Reagent Cartridge (Digxn), Model K6435KXT · Traditional | Siemens Healthcare Diagnostics | 04/07/2010SE |
| K082953 | Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01KXT · Traditional | Biokit, S.A. | 12/22/2008SE |
| K061249 | Axsym Digoxin IIIKXT · Special | Abbott Laboratories | 06/02/2006SE |
| K033007 | Bayer Advia Digoxin Assay for the Integrated Module SystemKXT · Traditional | Bayer Diagnostics Corp. | 11/14/2003SE |
| K023058 | QMS Digoxin Reagent System on the Abbott Aeroset SystemKXT · Traditional | Seradyn | 10/24/2002SE |
| K012301 | Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)KXT · Traditional | Diagnostic Products Corp. | 09/19/2001SE |
| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | Syva Co., Dade Behring, Inc. | 07/02/2001SE |
| K011302 | Randox DigoxinKXT · Traditional | Randox Laboratories, Ltd. | 07/02/2001SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | Diagnostic Reagents, Inc. | 11/12/1998SE |
| K983151 | Immage Immunochemistry System Digoxin (Dig) ReagentKXT · Traditional | Beckman Coulter, Inc. | 11/05/1998SE |
| K982935 | Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug CalibratorKXT · Traditional | Beckman Coulter, Inc. | 10/14/1998SE |
| K980521 | Digoxin Assay for the Technicon Ra / Opera SystemsKXT · Traditional | Bayer Corp. | 04/02/1998SE |
| K973112 | Elecsys DigoxinKXT · Traditional | Boehringer Mannheim Corp. | 10/10/1997SE |
| K972794 | Digoxin Dg-Ii Fpia Reagent SetKXT · Traditional | Sigma Diagnostics, Inc. | 07/31/1997SE |
| K970883 | Cedia Digoxin IIKXT · Traditional | Boehringer Mannheim Corp. | 05/21/1997SE |
| K970881 | Cedia DigoxinKXT · Traditional | Boehringer Mannheim Corp. | 05/14/1997SE |
| K963062 | Immage System Digoxin (Dig) Reagent/Beckman Drug Calibrator 2KXT · Traditional | Beckman Instruments, Inc. | 12/13/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | Diagnostic Reagents, Inc. | 12/10/1996SE |
| K953718 | Axsym Digoxin IIKXT · Traditional | Abbott Laboratories | 09/25/1995SE |
| K952079 | Imx DigoxinKXT · Traditional | Abbott Laboratories | 07/19/1995SE |
| K951391 | Il Test Digoxin, PN 181761-00KXT · Traditional | Instrumentation Laboratory CO | 06/09/1995SE |
| K951755 | Emit 2000 Digoxin AssayKXT · Traditional | Syva Co. | 06/01/1995SE |
| K951441 | Dupont Aca Digoxin (DGN a) MethodKXT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/01/1995SE |
| K943983 | Il Test Digoxin & Il Test Digoxin CalibratorsKXT · Traditional | Instrumentation Laboratory CO | 04/10/1995SE |
| K946153 | Digoxin Flex(Tm) Reagent CartridgeKXT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/22/1995SE |
| K944506 | Axsym DigoxinKXT · Traditional | Abbott Laboratories | 12/19/1994SE |
| K943500 | Emit 2000 Digoxin AssayKXT · Traditional | Syva Co. | 11/15/1994SE |
| K940569 | Digoxin Fpia Reagent Set and Calibrator SetKXT · Traditional | Sigma Diagnostics, Inc. | 07/13/1994SE |
| K941255 | Cedia Digoxin Plus AssayKXT · Traditional | Microgenics Corp. | 06/13/1994SE |
| K940267 | Ace Clinical Chemistry SystemKXT · Traditional | Schiapparelli Biosystems, Inc. | 05/03/1994SE |
| K934135 | Emit 2000 Digoxin Assay/Calibrators ModificationKXT · Traditional | Syva Co. | 04/06/1994SE |
| K934168 | Cedia Digoxin Plus AssayKXT · Traditional | Microgenics Corp. | 12/29/1993SE |
| K932732 | Aca(R) Digoxin Analytical Test Pack (DGN)KXT · Traditional | Dupont Medical Products | 11/15/1993SE |
| K932250 | Vidas Digoxin (Dig)KXT · Traditional | Biomerieux Vitek, Inc. | 09/10/1993SE |
| K931123 | Digoxin Test System, KXT TXKXT · Traditional | Syva Co. | 08/05/1993SE |
| K931213 | Acs Digoxin ImmunoassayKXT · Traditional | Ciba Corning Diagnostics Corp. | 06/07/1993SE |
| K930162 | Aca Digoxin Analytical Test PackKXT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/10/1993SE |
| K925802 | Access Digoxin AssayKXT · Traditional | Bio-Rad Laboratories, Inc. | 01/13/1993SE |
| K924504 | Fast Digoxin Test SystemKXT · Traditional | Diatron Corp. | 01/13/1993SE |
| K924594 | Delfia Digoxin KitKXT · Traditional | Wallac OY | 12/17/1992SE |
| K923853 | Cedia Digoxin Plus AssayKXT · Traditional | Microgenics Corp. | 09/15/1992SE |
| K920214 | Cedia Digoxin Assay (Modification)KXT · Traditional | Microgenics Corp. | 03/02/1992SE |
| K915602 | Sri Digoxin Enzyme ImmunoassayKXT · Traditional | Serono-Baker Diagnostics, Inc. | 01/17/1992SE |
| K914151 | Il Test(Tm DigoxinKXT · Traditional | Instrumentation Laboratory CO | 11/29/1991SE |
| K911941 | Cedia(R) Digoxin R' AssayKXT · Traditional | Microgenics Corp. | 05/15/1991SE |
| K910642 | Cedia(R) Digoxin SC AssayKXT · Traditional | Microgenics Corp. | 03/21/1991SE |
| K901547 | Opus(Tm) Digoxin Test SystemKXT · Traditional | Pb Diagnostic Systems, Inc. | 06/26/1990SE |
| K901216 | Enzymun Test(R) DigoxinKXT · Traditional | Boehringer Mannheim Corp. | 05/31/1990SE |
| K896863 | Digoxin-Eia-XtKXT · Traditional | In Vitro Diagnostics, Inc. | 02/13/1990SE |
| K893843 | Ez-Bead Digoxin Eia KitKXT · Traditional | Immunotech Corp. | 09/28/1989SE |
| K894521 | FPR Digoxin KitKXT · Traditional | Colony Laboratories, Inc. | 09/25/1989SE |
| K893910 | Emit Convenience Pack: Digoxin AssayKXT · Traditional | Syva Co. | 08/21/1989SE |
| K884528 | Seralyzer Digoxin Assay/Test Mod/Calib/Contr/AmesKXT · Traditional | Heraeus Kulzer, Inc. | 03/08/1989SE |
| K884054 | Modification of the Cedia Digoxin AssayKXT · Traditional | Microgenics Corp. | 12/02/1988SE |
| K882233 | TDX (R) Digoxin NXTKXT · Traditional | Abbott Laboratories | 07/06/1988SE |
| K880823 | Amerlite Digoxin Assay, LAN.0700/2700, 240/144 KitKXT · Traditional | Amersham Corp. | 05/31/1988SE |
| K872583 | Cedia Digoxin CR AssayKXT · Traditional | Microgenics Corp. | 08/28/1987SE |
| K864223 | Iq DigoxinKXT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/28/1987SE |
| K870552 | Affinity Digoxin ImmunitKXT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/13/1987SE |
| K870951 | Digoxin Fpia Reagent SetKXT · Traditional | Sigma Diagnostics, Inc. | 04/01/1987SE |
| K864333 | Digoxin Fpia Fluorescence Polarization ImmunoassayKXT · Traditional | Windsor Laboratories, Inc. | 01/05/1987SE |
| K861195 | Delfia DigoxinKXT · Traditional | Lkb Instruments, Inc. | 07/11/1986SE |
| K861394 | Emit Digoxin Mobile Phase SolutionKXT · Traditional | Syva Co. | 05/29/1986SE |
| K861393 | Emit Column Digoxin AssayKXT · Traditional | Syva Co. | 05/29/1986SE |
| K854638 | Cedia Digoxin AssayKXT · Traditional | Microgenics Corp. | 03/25/1986SE |
| K854972 | V-Trend Dig Enzyme Immunoassay Test KitKXT · Traditional | V-Tech, Inc. | 01/22/1986SE |
| K851032 | Cobas FP Reagents for Digoxin & Cobas FP Digoxin CKXT · Traditional | Roche Diagnostic Systems, Inc. | 04/03/1985SE |
| K850458 | Dupont Digoxin Assay ReagentsKXT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/05/1985SE |
| K842655 | Epsilon Digoxin Test KitKXT · Traditional | Beckman Instruments, Inc. | 08/16/1984SE |
| K842571 | Immpulse Digoxin Assay ReagentsKXT · Traditional | Aktis Corp. | 08/16/1984SE |
| K841582 | Optimate Digoxin TestKXT · Traditional | Miles Laboratories, Inc. | 05/11/1984SE |
| K841107 | Aca Digoxin Analytical Test PackKXT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/19/1984SE |
| K840673 | Sensibead Eia Digoxin KitKXT · Traditional | Terumo Medical Corp. | 03/12/1984SE |
| K833878 | Ventrezyme Digoxin Immunoassay DigoxKXT · Traditional | Vxr, Inc. | 01/13/1984SE |
| K833791 | Syva Advance Digoxin AssayKXT · Traditional | Syva Co. | 01/12/1984SE |
| K831177 | Stratus Digoxin Fluorometric Enzyme Imm-KXT · Traditional | American Dade | 05/17/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | Icl Scientific | 11/29/1982SE |
| K812054 | Endab Digoxin KitKXT · Traditional | Immunotech Corp. | 08/12/1981SE |
| K802358 | Oreia-Q-DigKXT · Traditional | Organon, Inc. | 10/10/1980SE |
| K790937 | Emit Auto Digoxin AssayKXT · Traditional | Syva Co. | 06/15/1979SE |
| K790521 | Oreia - DigoxinKXT · Traditional | Organon, Inc. | 04/10/1979SE |
| K790303 | Emit Auto Digoxin AssayKXT · Traditional | Syva Co. | 03/19/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2607-2017 Class II | Dimension Vista Digoxin (DIGXN) Flex reagent cartridgeThe concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and… | Siemens Healthcare Diagnostics, Inc. | 03/21/2017Terminated |
| Z-1151-2013 Class II | Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in…Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R)… | Siemens Healthcare Diagnostics, Inc. | 02/21/2013Terminated |
| Z-0297-2009 | AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II…AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The… | Abbott Diagnostic International, Ltd. | 05/22/2008Terminated |
| Z-0064-2008 | Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20)…Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the… | Abbott Diagnostic International, Ltd. | 07/20/2007Terminated |
| Z-1202-2007 | Abbott AxSYM System Digoxin III Reagent PackCustomers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM… | Abbott Diagnostic International, Ltd. | 03/30/2007Terminated |
| Z-0736-2007 | Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400…The lower detection limit (LDL) may be a higher value than stated in the labeling. Note: To resolve this… | Roche Diagnostics Corp. | 03/16/2007Terminated |