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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: DDR FDA class 2

    Myoglobin, Antigen, Antiserum, Control

    Immunology

    View full classification →

    This is an immunological reagent kit for detecting and measuring myoglobin, an oxygen-storage protein in muscle tissue that is released into the circulation following ischemic or traumatic muscle injury, including antigen, antiserum, and control components for clinical immunoassay testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDR, regulated under 21 CFR 866.5680, within the Immunology specialty.

    510(k) Clearances

    46 matches
    K Number
    Device Name
    Access Myoglobin
    DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
    ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
    ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
    ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
    TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
    ARCHITECT STAT MYO IMMUNOASSAY
    QUANTEX MYOGLOBIN
    VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERS
    MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
    RAMP MYOGLOBIN ASSAY
    RANDOX MYOGLOBIN
    ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
    K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
    IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
    MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
    OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
    STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
    MYOGLOBIN FLEX REAGENT CARTRIDGE
    IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
    ABBOTT AXSYM MYOGLOBIN
    MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
    ELECSYS MYOGLOBIN STAT ASSAY
    AIA-PACK MYOGLOBIN ASSAY
    STRATUS CS MYOGLOBIN (MYO) TESTPAK
    CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
    TINAQUANT MYOGLOBIN ASSAY
    STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
    TARGET MYOGLOBIN TEST
    MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
    ACCESS MYOGLOBIN REAGENTS
    CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
    LIFESIGN MI MYOGLOBIN
    MYOGLOBIN ELISA TEST KIT
    STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY
    DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
    MYOGLOBIN RIA TEST KIT
    OPUS MYOGLOBIN TEST SYSTEM
    TURBIQUANT MYOGLOBIN
    TURBIQUANT MYOGLOBIN
    MYOGLOBIN RIA TEST KIT
    NA LATEX MYOGLOBIN TEST
    MYOLEX
    KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT
    HEMAGGLUTINATION INHIBITION TEST
    ANTISERA TO HUMAN FAB FRAGMENT

    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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