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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: KXT FDA class 2

    Enzyme Immunoassay, Digoxin

    Clinical Toxicology

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ADVIA Centaur® Digoxin assay
    Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
    RANDOX DIGOXIN ASSAY
    DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
    ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
    AXSYM DIGOXIN III
    BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
    QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
    IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
    RANDOX DIGOXIN
    EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
    DIGOXIN IMMUNOASSAY
    IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
    SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
    DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
    ELECSYS DIGOXIN
    DIGOXIN DG-II FPIA REAGENT SET
    CEDIA DIGOXIN II
    CEDIA DIGOXIN
    IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
    DIGOXIN ENZYME IMMUNOASSAY
    AXSYM DIGOXIN II
    IMX DIGOXIN
    IL TEST DIGOXIN, PN 181761-00
    EMIT 2000 DIGOXIN ASSAY
    DUPONT ACA DIGOXIN (DGN A) METHOD
    IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
    DIGOXIN FLEX(TM) REAGENT CARTRIDGE
    AXSYM DIGOXIN
    EMIT 2000 DIGOXIN ASSAY
    DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
    CEDIA DIGOXIN PLUS ASSAY
    ACE CLINICAL CHEMISTRY SYSTEM
    EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
    CEDIA DIGOXIN PLUS ASSAY
    ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)
    VIDAS DIGOXIN (DIG)
    DIGOXIN TEST SYSTEM, KXT TX
    ACS DIGOXIN IMMUNOASSAY
    ACA DIGOXIN ANALYTICAL TEST PACK
    FAST DIGOXIN TEST SYSTEM
    ACCESS DIGOXIN ASSAY
    DELFIA DIGOXIN KIT
    CEDIA DIGOXIN PLUS ASSAY
    CEDIA DIGOXIN ASSAY (MODIFICATION)
    SRI DIGOXIN ENZYME IMMUNOASSAY
    IL TEST(TM DIGOXIN
    CEDIA(R) DIGOXIN R' ASSAY
    CEDIA(R) DIGOXIN SC ASSAY
    OPUS(TM) DIGOXIN TEST SYSTEM

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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