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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: DAP FDA class 2

    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

    Hematology

    View full classification →

    This is an immunological reagent kit for detecting fibrinogen and its degradation products (fibrin split products), which accumulate in conditions such as disseminated intravascular coagulation (DIC) and are used as markers of fibrinolysis and coagulation disorders. The kit includes antigen, antiserum, and control components for use in hematology laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAP, regulated under 21 CFR 864.7320, within the Hematology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HemosIL D-Dimer HS 500
    STA® - Liatest® D-Di
    HemosIL D-Dimer HS
    HemosIL D-Dimer HS
    STA LIATEST D-DI
    VIDAS D-DIMER EXCLUSION II (DEX2)
    STRATUS CS ACUTE CARE D-DIMER
    INNOVANCE D-DIMER, MODEL OPBP09
    HEMOSIL D-DIMER HS 500, CONTROLS
    INNOVANCE D-DIMER, MODEL OPBP09
    INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
    HEMOSIL D-DIMER
    DIMERTEST
    HEMOSIL D-DIMER HS
    STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
    STRATUS CS D-DIMER
    HEMOSIL D-DIMER HS
    HEMOSIL D-DIMER
    TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
    ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS
    ADVANCED D-DIMER ASSAY
    TRIAGE PROFILER S.O.B. PANEL
    VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
    QUANTEX D-DIMER
    VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
    K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
    STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
    STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
    VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
    AUTODIMER ASSAY MODEL # 1431
    SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
    K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
    ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
    SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
    MINIQUANT D-DIMER, MODEL 1447
    MDA D-DIMER
    ADVANCED D-DIMER
    DIMERTEST LATEX ASSAY
    MDA D-DIMER
    VIDAS D-DIMER (DD) ASSAY
    IL TEST D-DIMER
    STA-LIATEST D-DI TEST KIT
    STA D-DI CALIBRATOR KIT
    MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS
    AURATEK FDP
    FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2
    FIBRINOSTIKA TDP MICROELISA SYSTEM
    FDP PLASMA TEST KIT

    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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