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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: LFZ FDA class 2

    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

    Microbiology

    View full classification →

    An enzyme-linked immunosorbent assay (ELISA) for cytomegalovirus (CMV) is a laboratory diagnostic test used to detect CMV-specific antibodies in patient serum, supporting the diagnosis of active or past CMV infection, which is clinically significant in immunocompromised patients and during pregnancy. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LFZ and is regulated under 21 CFR 866.3175 within the Microbiology specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Architect CMV IgG
    Elecsys CMV IgG
    ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
    Elecsys CMV IgM
    LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
    ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
    ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
    DIASORIN LIAISON CMV IGM/IGG
    IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
    SERAQUEST CMV IGM
    THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
    THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
    MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
    DIAMEDIX IS-CMV IGG TEST SYSTEM
    QUANTA LITE CMV IGG ELISA
    ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
    HEMAGEN CMV IGG KIT
    INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
    OPUS CMV TEST SYSTEM-MODIFICATION
    AXSYM CMV IGG ANTIBODY ASSAY
    INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
    INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
    IMMULITE CMV IGG
    SERAQUEST CMV IGG
    OPUS CMV-G
    BARTELS CYTOMEGALOVIRUS IGG EIA
    CMV ELISA TEST SYSTEM
    VIDAS CMV IGG ASSAY
    PHARMACIA CMV IGM ELISA
    CAPTIA CMV-TA
    ENZYGNOST(R) ANTI-CMV IGG
    ENZYGNOST(R) ANTI-CMV/IGM
    CMV IGG ELISA TEST
    ENZYGNOST ANTI-CMV/IGG + IGM
    CYTOMEGALOVIRUS (CMV) ELISA
    CMV IGM ELISA TEST
    ORTHO CMV-M ANTIBODY ELISA TEST
    ORTHO CMV-G ANTIBODY ELISA TEST
    IMX CMV IGG ANTIBODY ASSAY
    IMX CMV IGM ANTIBODY ASSAY
    CMV IGG ELISA TEST
    CAPTIA(R) CMV-G
    CAPTIA(R) CMV-M
    CMV IGM ELISA TEST SYSTEM
    DETECTADOT TM SYSTEM 2000 CMV IGM TEST
    VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
    ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
    CMV ELISA TEST SYSTEM
    CMV-CUBE(TM)
    MODIFIED DDI SEROCARD CMV IGG TEST 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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