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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: LIP FDA class 2

    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

    Microbiology

    View full classification →

    An enzyme-linked immunosorbent assay (ELISA) for Treponema pallidum is a laboratory diagnostic test that detects antibodies to Treponema pallidum, the causative agent of syphilis, in patient serum, supporting the serological diagnosis and confirmation of syphilitic infection. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIP and is regulated under 21 CFR 866.3830 within the Microbiology specialty. No special flags apply to this device.

    510(k) Clearances

    35 matches
    K Number
    Device Name
    Access Syphilis
    VITROS Immunodiagnostic Products Syphilis Reagent Pack
    Elecsys Syphilis
    BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
    Elecsys Syphilis
    Lumipulse G TP-N Immunoreaction Cartridge Set
    ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
    BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
    TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS
    SYPHILIS HEALTH CHECK
    ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
    ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
    IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
    BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
    ENZY-WELL SYPHILIS IGG, MODEL 91106
    TREP-SURE TREPONEMAL ANTIBODY EIA
    DIASORIN LIAISON TREPONEMA ASSAY
    CAPTIAM SYPHILIS-G ASSAY
    CAPTIA SYPHILIS-G ELISA TEST SYSTEM
    TREPCHEK TREPONEMAL ANTIBODY EIA
    COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
    SYPHILIS IGM HUMAN SERUM CONTROLS
    SYPHILIS IGG HUMAN SERUM CONTROLS
    VISUWELL SYPHILIS ANTIBODY
    VISUWELL SYPHILIS ANTIGEN
    DCL SYPHILIS-M CATALOG NO. 600-80
    DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
    CAPTIA(R) SYPHILIS M, MODIFICATION
    MODIFIED CAPTIA(R) SYPHILIS-M
    ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
    ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
    CAPTIA(R) SYPHILIS-G
    CAPTIA(R) SYPHILIS-M
    CORDIA S4 -TREPONEMA PALLIDUM
    SYPHILIS BIO-ENZABEAD 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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