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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: MMI FDA class 2

    Immunoassay Method, Troponin Subunit

    Clinical Chemistry

    View full classification →

    The Troponin Subunit Immunoassay is an in vitro diagnostic device used to measure the concentration of cardiac troponin I or troponin T subunits in patient blood, which are highly specific biomarkers for myocardial injury used in the diagnosis of acute myocardial infarction and risk stratification in patients with chest pain. Classified as a Class 2 device under 21 CFR 862.1215 within the Clinical Chemistry specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Access hsTnI
    i-STAT hs-TnI cartridge with the i-STAT 1 System
    Atellica® IM High-Sensitivity Troponin I (TnIH)
    PATHFAST®hs-cTnI-II
    Access hsTnI
    Access hsTnI
    Alinity i STAT High Sensitivity Troponin-I
    Alinity i STAT High Sensitivity Troponin-I
    Elecsys Troponin T Gen 5
    ARCHITECT STAT High Sensitivity Troponin-I
    Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
    Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
    Atellica IM High-Sensitivity Troponin I (TNIH)
    ADVIA Centaur High-Sensitivity Troponin I (TNIH)
    Access hsTnl
    Access hs Tnl
    Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
    ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
    ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
    PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
    NANO-CHECK AMI CTNI CARDIAC MARKER TEST
    NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
    ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
    DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
    VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
    ARCHITECT STAT TROPONIN-1; MYOGLOBIN
    DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
    VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
    ABBOTT AXSYM TROPONIN-I ADV
    DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
    NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
    TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
    TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
    CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
    VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
    ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
    BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
    INSTANT-VIEW TROPONIN I TEST
    ABBOTT AXSYM TROPONIN-I ADV
    ARCHITECT STAT TROPONIN-I IMMUNOASSAY
    ELECSYS TROPONIN T STAT TEST
    RAMP TROPONIN I ASSAY
    STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
    I-STAT CARDIAC TROPONIN (CTNI) TEST
    VIDAS TROPONIN I (TNI), MODEL 30 445
    VBL SERUM TROPONIN I TEST, MODEL 1001
    SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
    MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
    LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST

    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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