Product Code: KXT FDA class 2 21 CFR 862.3320

Enzyme Immunoassay, Digoxin

Clinical Toxicology

The Digoxin Enzyme Immunoassay is an in vitro diagnostic device used to measure digoxin concentrations in patient serum or plasma, supporting therapeutic drug monitoring for patients prescribed this cardiac glycoside to treat heart failure and arrhythmias. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KXT, regulated under 21 CFR 862.3320, in the Clinical Toxicology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KXT
Device Class: FDA class 2
Regulation Number: 862.3320
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 85 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K193397	ADVIA Centaur® Digoxin assay	Jul 16, 2021	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K153301	Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II	Apr 08, 2016	Substantially Equivalent	Roche Diagnostics
K102346	RANDOX DIGOXIN ASSAY	Oct 14, 2011	Substantially Equivalent	Randox Laboratories, Ltd.
K093441	DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435	Apr 07, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K082953	ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01	Dec 22, 2008	Substantially Equivalent	Biokit, S.A.
K061249	AXSYM DIGOXIN III	Jun 02, 2006	Substantially Equivalent	Abbott Laboratories
K033007	BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM	Nov 14, 2003	Substantially Equivalent	Bayer Diagnostics Corp.
K023058	QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM	Oct 24, 2002	Substantially Equivalent	Seradyn
K012301	IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)	Sep 19, 2001	Substantially Equivalent	Diagnostic Products Corp.
K011920	EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229	Jul 02, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K011302	RANDOX DIGOXIN	Jul 02, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K983323	DIGOXIN IMMUNOASSAY	Nov 12, 1998	Substantially Equivalent	Diagnostic Reagents, Inc.
K983151	IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT	Nov 05, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K982935	SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR	Oct 14, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K980521	DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS	Apr 02, 1998	Substantially Equivalent	Bayer Corp.
K973112	ELECSYS DIGOXIN	Oct 10, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K972794	DIGOXIN DG-II FPIA REAGENT SET	Jul 31, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K970883	CEDIA DIGOXIN II	May 21, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970881	CEDIA DIGOXIN	May 14, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K963062	IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2	Dec 13, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K963835	DIGOXIN ENZYME IMMUNOASSAY	Dec 10, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K953718	AXSYM DIGOXIN II	Sep 25, 1995	Substantially Equivalent	Abbott Laboratories
K952079	IMX DIGOXIN	Jul 19, 1995	Substantially Equivalent	Abbott Laboratories
K951391	IL TEST DIGOXIN, PN 181761-00	Jun 09, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K951755	EMIT 2000 DIGOXIN ASSAY	Jun 01, 1995	Substantially Equivalent	Syva Co.
K951441	DUPONT ACA DIGOXIN (DGN A) METHOD	Jun 01, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K943983	IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS	Apr 10, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K946153	DIGOXIN FLEX(TM) REAGENT CARTRIDGE	Feb 22, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K944506	AXSYM DIGOXIN	Dec 19, 1994	Substantially Equivalent	Abbott Laboratories
K943500	EMIT 2000 DIGOXIN ASSAY	Nov 15, 1994	Substantially Equivalent	Syva Co.
K940569	DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET	Jul 13, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K941255	CEDIA DIGOXIN PLUS ASSAY	Jun 13, 1994	Substantially Equivalent	Microgenics Corp.
K940267	ACE CLINICAL CHEMISTRY SYSTEM	May 03, 1994	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K934135	EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION	Apr 06, 1994	Substantially Equivalent	Syva Co.
K934168	CEDIA DIGOXIN PLUS ASSAY	Dec 29, 1993	Substantially Equivalent	Microgenics Corp.
K932732	ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)	Nov 15, 1993	Substantially Equivalent	Dupont Medical Products
K932250	VIDAS DIGOXIN (DIG)	Sep 10, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K931123	DIGOXIN TEST SYSTEM, KXT TX	Aug 05, 1993	Substantially Equivalent	Syva Co.
K931213	ACS DIGOXIN IMMUNOASSAY	Jun 07, 1993	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K930162	ACA DIGOXIN ANALYTICAL TEST PACK	Mar 10, 1993	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K925802	ACCESS DIGOXIN ASSAY	Jan 13, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K924504	FAST DIGOXIN TEST SYSTEM	Jan 13, 1993	Substantially Equivalent	Diatron Corp.
K924594	DELFIA DIGOXIN KIT	Dec 17, 1992	Substantially Equivalent	Wallac OY
K923853	CEDIA DIGOXIN PLUS ASSAY	Sep 15, 1992	Substantially Equivalent	Microgenics Corp.
K920214	CEDIA DIGOXIN ASSAY (MODIFICATION)	Mar 02, 1992	Substantially Equivalent	Microgenics Corp.
K915602	SRI DIGOXIN ENZYME IMMUNOASSAY	Jan 17, 1992	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K914151	IL TEST(TM DIGOXIN	Nov 29, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K911941	CEDIA(R) DIGOXIN R' ASSAY	May 15, 1991	Substantially Equivalent	Microgenics Corp.
K910642	CEDIA(R) DIGOXIN SC ASSAY	Mar 21, 1991	Substantially Equivalent	Microgenics Corp.
K901547	OPUS(TM) DIGOXIN TEST SYSTEM	Jun 26, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K901216	ENZYMUN TEST(R) DIGOXIN	May 31, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K896863	DIGOXIN-EIA-XT	Feb 13, 1990	Substantially Equivalent	In Vitro Diagnostics, Inc.
K893843	EZ-BEAD DIGOXIN EIA KIT	Sep 28, 1989	Substantially Equivalent	Immunotech Corp.
K894521	FPR DIGOXIN KIT	Sep 25, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K893910	EMIT CONVENIENCE PACK: DIGOXIN ASSAY	Aug 21, 1989	Substantially Equivalent	Syva Co.
K884528	SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES	Mar 08, 1989	Substantially Equivalent	Heraeus Kulzer, Inc.
K884054	MODIFICATION OF THE CEDIA DIGOXIN ASSAY	Dec 02, 1988	Substantially Equivalent	Microgenics Corp.
K882233	TDX (R) DIGOXIN NXT	Jul 06, 1988	Substantially Equivalent	Abbott Laboratories
K880823	AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT	May 31, 1988	Substantially Equivalent	Amersham Corp.
K872583	CEDIA DIGOXIN CR ASSAY	Aug 28, 1987	Substantially Equivalent	Microgenics Corp.
K864223	IQ DIGOXIN	Aug 28, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870552	AFFINITY DIGOXIN IMMUNIT	Apr 13, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870951	DIGOXIN FPIA REAGENT SET	Apr 01, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K864333	DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY	Jan 05, 1987	Substantially Equivalent	Windsor Laboratories, Inc.
K861195	DELFIA DIGOXIN	Jul 11, 1986	Substantially Equivalent	Lkb Instruments, Inc.
K861394	EMIT DIGOXIN MOBILE PHASE SOLUTION	May 29, 1986	Substantially Equivalent	Syva Co.
K861393	EMIT COLUMN DIGOXIN ASSAY	May 29, 1986	Substantially Equivalent	Syva Co.
K854638	CEDIA DIGOXIN ASSAY	Mar 25, 1986	Substantially Equivalent	Microgenics Corp.
K854972	V-TREND DIG ENZYME IMMUNOASSAY TEST KIT	Jan 22, 1986	Substantially Equivalent	V-Tech, Inc.
K851032	COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C	Apr 03, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K850458	DUPONT DIGOXIN ASSAY REAGENTS	Mar 05, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K842655	EPSILON DIGOXIN TEST KIT	Aug 16, 1984	Substantially Equivalent	Beckman Instruments, Inc.
K842571	IMMPULSE DIGOXIN ASSAY REAGENTS	Aug 16, 1984	Substantially Equivalent	Aktis Corp.
K841582	OPTIMATE DIGOXIN TEST	May 11, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K841107	ACA DIGOXIN ANALYTICAL TEST PACK	Apr 19, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K840673	SENSIBEAD EIA DIGOXIN KIT	Mar 12, 1984	Substantially Equivalent	Terumo Medical Corp.
K833878	VENTREZYME DIGOXIN IMMUNOASSAY DIGOX	Jan 13, 1984	Substantially Equivalent	Vxr, Inc.
K833791	SYVA ADVANCE DIGOXIN ASSAY	Jan 12, 1984	Substantially Equivalent	Syva Co.
K831177	STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-	May 17, 1983	Substantially Equivalent	American Dade
K823199	ENZYME-TEST DIGOXIN	Nov 29, 1982	Substantially Equivalent	Icl Scientific
K812054	ENDAB DIGOXIN KIT	Aug 12, 1981	Substantially Equivalent	Immunotech Corp.
K802358	OREIA-Q-DIG	Oct 10, 1980	Substantially Equivalent	Organon, Inc.
K790937	EMIT AUTO DIGOXIN ASSAY	Jun 15, 1979	Substantially Equivalent	Syva Co.
K790521	OREIA - DIGOXIN	Apr 10, 1979	Substantially Equivalent	Organon, Inc.
K790303	EMIT AUTO DIGOXIN ASSAY	Mar 19, 1979	Substantially Equivalent	Syva Co.