Atlas FDA

KXT

85 FDA 510(k) clearances · Product code

64 daysmedian time to decision
153 days90th percentile
85clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Digoxin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3320
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 11 · 2011: 19 · 2012: 15 · 2013: 39 · 2014: 7 · 2017: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ADVIA Centaur® Digoxin assay (K193397)Siemens Healthcare Diagnostics, Inc.2021-07-16
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (K153301)Roche Diagnostics2016-04-08
RANDOX DIGOXIN ASSAY (K102346)Randox Laboratories, Ltd.2011-10-14
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (K093441)Siemens Healthcare Diagnostics2010-04-07
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 (K082953)Biokit, S.A.2008-12-22
AXSYM DIGOXIN III (K061249)Abbott Laboratories2006-06-02
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (K033007)Bayer Diagnostics Corp.2003-11-14
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (K023058)Seradyn2002-10-24
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (K012301)Diagnostic Products Corp.2001-09-19
RANDOX DIGOXIN (K011302)Randox Laboratories, Ltd.2001-07-02
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (K011920)Syva Co., Dade Behring, Inc.2001-07-02
DIGOXIN IMMUNOASSAY (K983323)Diagnostic Reagents, Inc.1998-11-12
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT (K983151)Beckman Coulter, Inc.1998-11-05
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR (K982935)Beckman Coulter, Inc.1998-10-14
DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS (K980521)Bayer Corp.1998-04-02
ELECSYS DIGOXIN (K973112)Boehringer Mannheim Corp.1997-10-10
DIGOXIN DG-II FPIA REAGENT SET (K972794)Sigma Diagnostics, Inc.1997-07-31
CEDIA DIGOXIN II (K970883)Boehringer Mannheim Corp.1997-05-21
CEDIA DIGOXIN (K970881)Boehringer Mannheim Corp.1997-05-14
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 (K963062)Beckman Instruments, Inc.1996-12-13
DIGOXIN ENZYME IMMUNOASSAY (K963835)Diagnostic Reagents, Inc.1996-12-10
AXSYM DIGOXIN II (K953718)Abbott Laboratories1995-09-25
IMX DIGOXIN (K952079)Abbott Laboratories1995-07-19
IL TEST DIGOXIN, PN 181761-00 (K951391)Instrumentation Laboratory CO1995-06-09
DUPONT ACA DIGOXIN (DGN A) METHOD (K951441)E.I. Dupont DE Nemours & Co., Inc.1995-06-01
EMIT 2000 DIGOXIN ASSAY (K951755)Syva Co.1995-06-01
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS (K943983)Instrumentation Laboratory CO1995-04-10
DIGOXIN FLEX(TM) REAGENT CARTRIDGE (K946153)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
AXSYM DIGOXIN (K944506)Abbott Laboratories1994-12-19
EMIT 2000 DIGOXIN ASSAY (K943500)Syva Co.1994-11-15
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET (K940569)Sigma Diagnostics, Inc.1994-07-13
CEDIA DIGOXIN PLUS ASSAY (K941255)Microgenics Corp.1994-06-13
ACE CLINICAL CHEMISTRY SYSTEM (K940267)Schiapparelli Biosystems, Inc.1994-05-03
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION (K934135)Syva Co.1994-04-06
CEDIA DIGOXIN PLUS ASSAY (K934168)Microgenics Corp.1993-12-29
ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN) (K932732)Dupont Medical Products1993-11-15
VIDAS DIGOXIN (DIG) (K932250)Biomerieux Vitek, Inc.1993-09-10
DIGOXIN TEST SYSTEM, KXT TX (K931123)Syva Co.1993-08-05
ACS DIGOXIN IMMUNOASSAY (K931213)Ciba Corning Diagnostics Corp.1993-06-07
ACA DIGOXIN ANALYTICAL TEST PACK (K930162)E.I. Dupont DE Nemours & Co., Inc.1993-03-10
FAST DIGOXIN TEST SYSTEM (K924504)Diatron Corp.1993-01-13
ACCESS DIGOXIN ASSAY (K925802)Bio-Rad Laboratories, Inc.1993-01-13
DELFIA DIGOXIN KIT (K924594)Wallac OY1992-12-17
CEDIA DIGOXIN PLUS ASSAY (K923853)Microgenics Corp.1992-09-15
CEDIA DIGOXIN ASSAY (MODIFICATION) (K920214)Microgenics Corp.1992-03-02
SRI DIGOXIN ENZYME IMMUNOASSAY (K915602)Serono-Baker Diagnostics, Inc.1992-01-17
IL TEST(TM DIGOXIN (K914151)Instrumentation Laboratory CO1991-11-29
CEDIA(R) DIGOXIN R' ASSAY (K911941)Microgenics Corp.1991-05-15
CEDIA(R) DIGOXIN SC ASSAY (K910642)Microgenics Corp.1991-03-21
OPUS(TM) DIGOXIN TEST SYSTEM (K901547)Pb Diagnostic Systems, Inc.1990-06-26
ENZYMUN TEST(R) DIGOXIN (K901216)Boehringer Mannheim Corp.1990-05-31
DIGOXIN-EIA-XT (K896863)In Vitro Diagnostics, Inc.1990-02-13
EZ-BEAD DIGOXIN EIA KIT (K893843)Immunotech Corp.1989-09-28
FPR DIGOXIN KIT (K894521)Colony Laboratories, Inc.1989-09-25
EMIT CONVENIENCE PACK: DIGOXIN ASSAY (K893910)Syva Co.1989-08-21
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES (K884528)Heraeus Kulzer, Inc.1989-03-08
MODIFICATION OF THE CEDIA DIGOXIN ASSAY (K884054)Microgenics Corp.1988-12-02
TDX (R) DIGOXIN NXT (K882233)Abbott Laboratories1988-07-06
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT (K880823)Amersham Corp.1988-05-31
IQ DIGOXIN (K864223)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-08-28
CEDIA DIGOXIN CR ASSAY (K872583)Microgenics Corp.1987-08-28
AFFINITY DIGOXIN IMMUNIT (K870552)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-04-13
DIGOXIN FPIA REAGENT SET (K870951)Sigma Diagnostics, Inc.1987-04-01
DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY (K864333)Windsor Laboratories, Inc.1987-01-05
DELFIA DIGOXIN (K861195)Lkb Instruments, Inc.1986-07-11
EMIT COLUMN DIGOXIN ASSAY (K861393)Syva Co.1986-05-29
EMIT DIGOXIN MOBILE PHASE SOLUTION (K861394)Syva Co.1986-05-29
CEDIA DIGOXIN ASSAY (K854638)Microgenics Corp.1986-03-25
V-TREND DIG ENZYME IMMUNOASSAY TEST KIT (K854972)V-Tech, Inc.1986-01-22
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C (K851032)Roche Diagnostic Systems, Inc.1985-04-03
DUPONT DIGOXIN ASSAY REAGENTS (K850458)E.I. Dupont DE Nemours & Co., Inc.1985-03-05
IMMPULSE DIGOXIN ASSAY REAGENTS (K842571)Aktis Corp.1984-08-16
EPSILON DIGOXIN TEST KIT (K842655)Beckman Instruments, Inc.1984-08-16
OPTIMATE DIGOXIN TEST (K841582)Miles Laboratories, Inc.1984-05-11
ACA DIGOXIN ANALYTICAL TEST PACK (K841107)E.I. Dupont DE Nemours & Co., Inc.1984-04-19
SENSIBEAD EIA DIGOXIN KIT (K840673)Terumo Medical Corp.1984-03-12
VENTREZYME DIGOXIN IMMUNOASSAY DIGOX (K833878)Vxr, Inc.1984-01-13
SYVA ADVANCE DIGOXIN ASSAY (K833791)Syva Co.1984-01-12
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM- (K831177)American Dade1983-05-17
ENZYME-TEST DIGOXIN (K823199)Icl Scientific1982-11-29
ENDAB DIGOXIN KIT (K812054)Immunotech Corp.1981-08-12
OREIA-Q-DIG (K802358)Organon, Inc.1980-10-10
EMIT AUTO DIGOXIN ASSAY (K790937)Syva Co.1979-06-15
OREIA - DIGOXIN (K790521)Organon, Inc.1979-04-10
EMIT AUTO DIGOXIN ASSAY (K790303)Syva Co.1979-03-19

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Every clearance here is in the API, with alerts when new ones post.