Atlas FDA

DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435

FDA 510(k) clearance K093441 · decided 2010-04-07

Clearance details

K-number
K093441
Device name
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-11-05
Decision date
2010-04-07
Days to decision
153 days
Clearance type
Traditional
Product code
KXT
Device class
2
Regulation number
862.3320
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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
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

Recalls involving this device

RecordFirmDate
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge recall (Z-2607-2017)Siemens Healthcare Diagnostics, Inc.2017-05-05
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vit recall (Z-1151-2013)Siemens Healthcare Diagnostics, Inc.2013-04-18

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024)Siemens Healthcare Diagnostics2025-10-17
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013)Siemens Healthcare Diagnostics2025-10-17
ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030)Siemens Healthcare Diagnostics2025-07-16
ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029)Siemens Healthcare Diagnostics2025-07-16
Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24