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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: CZW FDA class 2

    Complement C3, Antigen, Antiserum, Control

    Immunology

    View full classification →

    This is an immunological reagent kit for the detection and quantification of complement C3, the most abundant protein of the complement system and a central component in both the classical and alternative activation pathways. The kit includes antigen, antiserum, and control components for use in clinical immunology laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is CZW, regulated under 21 CFR 866.5240, within the Immunology specialty.

    510(k) Clearances

    44 matches
    K Number
    Device Name
    SPAPLUS
    COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
    DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
    N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
    VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III
    IBL C3D-CIC EIA TEST
    SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
    TINA-QUANT COMPLEMENT C3C TEST SYSTEM
    WAKO AUTOKIT C3
    RANDOX COMPLEMENT C3
    DIMENSION C3 FLEX REAGENT CARTRIDGE
    C3 MININEPH ANTISERUM
    K-ASSAY C3
    ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
    C3
    N-ASSAY TIA MULTI V-NL
    IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
    OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
    QUANTEX C3
    N PROTEIN STANDARS SY
    N PROTEIN STANDARD SY
    IL TEST COMPLEMENT 3
    RAICHEM SPIA C3 REAGENT
    C3C AND C4 RID KITS
    EZ COMPLEMENT C2
    EZ COMPLEMENT C3
    THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
    QM300 C3 ANTIBODY PACK
    PRECIMAT(R) C3
    DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
    IMMUNOMEDICS SERUM ELISA TEST SYSTEM
    GILFORD C3 COMPLEMENT REAGENT
    RADIAL IMMUNODIFFUSION PLATES C3 & C4
    SPQ TEST SYSTEM FOR COMPLEMENT C3
    C3 ANTISERUM CONTROL
    RABBITT ANTISERUM TO HUMAN C3C
    FIAX COMPLEMENT C3 TEST KIT
    IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3
    SCRIPPSYSTEM C3 RID KIT
    COMPLEMENT C3 NEPHELOMETRIC ASSAY
    COMPLEMENT C3 REAGENT SYSTEM
    LANCER L-INA ANTI-C3
    NEPHELRATE ANTISERUMS C3C
    SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN

    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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