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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: JHY FDA class 2

    Colorimetric Method, Cpk Or Isoenzymes

    Clinical Chemistry

    View full classification →

    Colorimetric Method for CPK or Isoenzymes is a clinical chemistry test system that employs colorimetric reactions to measure creatine kinase and its isoenzyme fractions in serum, supporting cardiac and muscular disease assessment. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JHY, regulated under 21 CFR 862.1215, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    Dimension Vista MMB Assay
    EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
    ELECSYS CK-MB STAT IMMUNOASSAY
    ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
    OLYMPUS CK-MB REAGENT
    SPIFE CK KIT, MODEL 3332, 3333
    MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
    ELECSYS CK-MB STAT
    MMB METHOD
    CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
    AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
    IMX(R) STAT CK-MB
    OPUS(R) CK-MB
    DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
    TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
    AMERLITE CK-MB ASSAY
    COBAS READY CK REAGENT
    ISOSCREEN-CK CONFIRMATORY KIT
    TARGET(TM) CK-MB
    CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
    TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
    IMX CKMB
    IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
    KODAK EKTACHEM DT SLIDES (CKMB)
    CREATINE KINASE (COLORIMETRIC METHOD)
    IMACK-MB TEST PROCEDURE (MODIFICATION)
    TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
    CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
    AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
    BAKER CKMB REAGENT SET
    FLOW-PAC CPK REAGENT SET
    TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY
    WAKO CPK TEST
    CREATINE KINASE REAGENT SET
    CREATINE KINASE-MB KIT
    REAGENT FOR DETERM. CREATINE PHOSPHOKINA
    CPK ISOENZYME REAGENT
    CPK ISOENZYME SUBSTRATE
    CPK1SOENZYMES DETERMINATION PRO. #715-EP
    LANCER MB/CPK ISOENZYME 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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