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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: JQB FDA class 1

    Kinetic Method, Gamma-Glutamyl Transpeptidase

    Clinical Chemistry

    View full classification →

    The Kinetic Method, Gamma-Glutamyl Transpeptidase test is a clinical chemistry diagnostic reagent used to measure GGT activity in serum by a kinetic (rate) reaction method, which monitors the continuous rate of substrate hydrolysis over time for precise enzyme activity determination in the evaluation of liver and biliary tract disease. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQB and is regulated under 21 CFR 862.1360, within the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
    LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
    SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
    ROCHE COBAS IBTEGRA REAGENT CASSETTES
    GAMMA-GLUTAMYL TRANSPEPTIDASE
    GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM
    Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05
    HICHEM Y-GT REAGENT KIT
    GGT QVET
    GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
    STANBIO Y-GT (LIQUICOLOR) TEST SET
    GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    SYNERMED GGT REAGENT KIT
    OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT
    ROCHE REAGENT FOR GGT
    GAMMA GULTAMYL TRANSFERASE TEST
    OLYMPUS GGT REAGENT
    TRACE GAMMA GT-SS REAGENT
    ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
    GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
    SYSTEMATE GGT (EPOS APPLICATION) #65414
    RAICHEM GGT REAGENT
    GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
    COULTER GAMMA-GT (GGT) REAGENT
    GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
    GAMMA-GLUTAMYLTRANSFERASE
    GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
    GAMMA-GLUTAMYL TRANSFERASE
    BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    GAMMA GLUTAMYLTRANSFERASE
    UNIFAST GAMMA-GT
    EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
    EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
    EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
    G-GT REAGENT
    Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
    GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
    SYSTEMATE 2GT - 67207
    DART GAMMA-GT REAGENT SYSTEM
    FLOW-PAC GGT REAGENT SET
    PARAMAX & GLUTAMYTRANSFERASE REAGENT
    ULTRA ZYME PLUS GAMMA GT #65055 & 56
    ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
    CAST SHOE, CAST BOOT
    ULTRAZYME PLUS GAMMA-GT, #64959/65032
    ULTRAZYME PLUS GAMMA GT(65055-65056)
    ULTRAZYME-GT, ITEM #64959 & 65032
    GAMMA GLUTAMY TRANSPEPTIDASE
    GAMMA-GT REAGENT SYSTEM
    Y-GT TEST, Y-GLUTAMYL TRANSFERASE 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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