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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: LFX FDA class 2

    Enzyme Linked Immunoabsorbent Assay, Rubella

    Microbiology

    View full classification →

    An enzyme-linked immunosorbent assay (ELISA) for rubella is a laboratory diagnostic test used to detect rubella-specific antibodies in serum, supporting the assessment of immune status and the diagnosis of current or past rubella infection, which is particularly important for women of childbearing age. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It carries product code LFX and is regulated under 21 CFR 866.3510 within the Microbiology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Alinity i Rubella IgG
    LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
    MAGO 4S
    BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
    ELECSYS RUBELLA IGM IMMUNOASSAY
    VIDAS RUB IGG
    ELECSYS RUBELLA IGG IMMUNOASSAY
    DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS
    ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM
    VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
    ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
    IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
    BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
    ADVIA CENTAUR RUBELLA IGG ASSAY
    DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
    COPALIS RUBELLA IGM
    THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
    THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
    IS-RUBELLA IGG TEST SYSTEM
    IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
    SERAQUEST RUBELLA IGM
    QUANTA LITE REBELLA IGG
    IMMULITE RUBELLA IGG
    RUBASCAN CARD TEST
    INCSTAR RUBELLA IGG FAST ELISA ASSAY
    INCSTAR RUBELLA IGG ELISA ASSAY
    AXSYM RUBELLA IGG ANTIBODY ASSAY
    SERAQUEST RUBELLA IGG
    IMX RUBELLA IGG
    ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
    RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
    ACCESS RUBELLA IGG
    RUBELISA (RUBESTAT)
    RUBELLA IGG ELISA TEST
    IMX RUBELLA IGM ANTIBODY ASSAY
    BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST
    BARTELS RUBELLA IGM EIA
    BARTELS RUBELLA IGG EIA
    RUBELLA IGM
    RUBELLA IGM ELISA TEST SYSTEM
    OPUS RUBELLA TEST SYSTEM
    RUBELLA IGG ELISA TEST
    ELISA RUBELLA IGM
    RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
    RUBENOSTIKA IGG MICROELISA SYSTEM
    TRANSTAT-CMV(TM)
    RUBELLA IGM ELISA TEST
    ORTHO RUBELLA-M ANTIBODY ELISA TEST
    MODIFICATION OF SEROCARD RUBELLA IGG TEST
    VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)

    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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