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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: JHX FDA class 2

    Fluorometric Method, Cpk Or Isoenzymes

    Clinical Chemistry

    View full classification →

    Fluorometric Method for CPK or Isoenzymes is a clinical chemistry test system that uses fluorescence detection to measure creatine kinase and its isoenzyme fractions, supporting diagnosis of myocardial infarction and skeletal muscle disorders. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JHX, 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

    48 matches
    K Number
    Device Name
    Access CK-MB
    VITROS Immunodiagnostic Products CK-MB Reagent Pack
    AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
    AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
    PATHFAST CK-MB-II, PATHFAST MYO-II
    STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
    ARCHITECT STAT CK-MB IMMUNOASSAY
    RAMP CK-MB ASSAY
    IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
    CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
    IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
    MODIFICATION TO ALPHA DX SYSTEM
    IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
    ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
    ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
    VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
    IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
    STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
    STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
    CREATINE KINASE REAGENT
    TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
    DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
    VIDAS CREATINE KINASE MB ASSAY 30-421
    MYDAS(TM)-MB2/MYDAS(TM)-MB
    AIA-PACK CK-MB
    CIBA CORNING ACS CKMB IMMUNOASSAY
    MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
    IMPRES-MB REAGENT A AND REAGENT B
    BIOTROL CK MONOEACTIF
    CREATINE KINASE (CK) REAGENT SET
    TITAN GEL REP CPK-6 HV
    TITAN GEL CPK REP SYSTEM
    STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
    CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
    CK-B RIA KIT
    CARDIOTRAC CORNING CK ISOENZYME SUBST
    ABURIA-CK RIA TEST KIT
    NML CK-MB RIA
    PARAGON ELECTRO. CREATINE KINASE TEST KI
    EMBRIA-CK
    HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
    CORNING TRANSPHOR
    RIA-QUANT CK-MB TEST KIT
    CARDIO CK-B RIA KIT
    BUFFER, CORNING MOPSO
    CREATINE KINASE ISOENZYME SUBSTRATE SET
    3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
    SIGMA PROCEDURE NO. 745 - EP.REAGENT SY

    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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