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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: JMO FDA class 1

    Ferrozine (Colorimetric) Iron Binding Capacity

    Clinical Chemistry

    View full classification →

    This device is a colorimetric clinical chemistry reagent system using ferrozine to measure total iron-binding capacity (TIBC) in serum, providing an estimate of transferrin saturation used in the evaluation of iron deficiency, iron overload, and anemia of chronic disease. It is classified as FDA Class 1 and requires only general controls with no premarket submission. The product code is JMO, regulated under 21 CFR 862.1415, and assigned to the Clinical Chemistry medical specialty.

    510(k) Clearances

    46 matches
    K Number
    Device Name
    ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
    VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
    VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
    OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
    WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
    BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
    DIRECT TIBC KIT
    TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
    TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
    TOTAL IRON, MODELS FE 109-01, FE 109-02
    MAGNETIC TIBC KIT
    UIBC
    TIBC
    TIBC
    RANDOX IRON
    IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25
    UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
    SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
    OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
    DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
    IRON/UIBC REAGENT
    KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
    KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
    PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
    SYNERMED UIBC REAGENT KIT
    J&S IRON REAGENTS
    J&S UIBC REAGENTS
    ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
    BIOTROL UIBC REAGENT
    IRON 5 X CONC REAGENT
    IRON REAGENTS PRODUCT CODES 7725 AND 7726
    J&S IRON SATURATING REAGENTS
    CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
    UNSATURATED IRON BINDING CAPACITY
    TOTAL IRON BINDING CAPACITY (TIBC)
    IRON REAGENT
    EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
    AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
    TDX REA IRON/TIBC
    SANDARE IRON-BINDING CAPACITY PROCEDURE
    SYSTE MATE TIBC HEM NO. 67225
    TOTAL IRON-BINDING CAPACITY ACCESORY
    SERUM UIBC-PTF-600 METHOD
    IRON BINDING CAPACITY CHEMISTRY
    IRON SET, ITEM NO. 65008
    TEST, FERROZINE IRON & IRON BINDING

    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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