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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: CGS FDA class 2

    Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

    Clinical Chemistry

    View full classification →

    The NAD Reduction/NADH Oxidation, CPK or Isoenzymes test system (product code CGS) is an in-vitro diagnostic device used in clinical chemistry to measure creatine phosphokinase (CPK) and its isoenzymes in serum using an NAD/NADH coupled enzymatic method, supporting the diagnosis of myocardial infarction and muscle disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1215 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Pointe Scientific Creatinine Kinase (CK) Reagent Set
    SEKURE Creatine Kinase Assay
    ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
    RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
    CPK REAGENT
    DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
    DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
    CREATINE KINASE LIQUID REAGENT, MODEL C519-440
    CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
    SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS
    OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
    WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
    CREATINE KINASE (CK-NAC)
    ATAC PAK CPK REAGENT KIT
    OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
    HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
    CK
    CREATINE KINASE (CK)
    N-ASSAY CPK-L
    CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
    CK-NAC REAGENT
    CREATINE KINASE (CK)
    CREATINE KINASE-MB REAGENT SET
    CK REAGENT
    HICHEM CK/NAC REAGENT KIT
    CK-MB (NAC-ACT)
    CREATINE KINASE REAGENT SYSTEM
    IL TEST CK-MB
    CK QVET
    CK-MB ASSAY, CATALOGUE NUMBER 317-10
    CREATINE KINASE-MB (CK-MB) REAGENT SET
    OPUS TOTAL CK
    CREATINE KINASE TEST
    KING DIAGNOSTICS CK REAGENT
    SYNERMED CREATINE KINASE REAGENT KIT
    CREATINE KINASE (CK) REAGENT SET
    OLYMPUS CREATINE KINASE REAGENT
    REP E-Z CK-30 ISOENZYME KIT
    CK-NAC ACTIVATED KIT
    CREATINE KINASE (CK) TEST ITEM #65411
    OLYMPUS CREATINE KINASE REAGENT
    CREATINE KINASE-MB (CK-MB) REAGENT SET
    CREATINE KINASE MB TEST ITEM NUMBER 5A46
    RAICHEM(TM) CREATINE KINASE-MB REAGENT
    RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
    AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
    CREATINE PHOSPHOKINASE
    REFLOTRON CREATINE KINASE TEST TABS
    CREATINE KINASE TEST (CK) ITEM NUMBER 65411
    CREATINE KINASE-MB TEST (MB-DS) ITEM #67655

    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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