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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: LGD FDA class 2

    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

    Microbiology

    View full classification →

    An enzyme-linked immunosorbent assay (ELISA) for Toxoplasma gondii is a laboratory diagnostic test used to detect antibodies to Toxoplasma gondii in patient serum, supporting diagnosis of toxoplasmosis, a parasitic infection of particular clinical concern in immunocompromised individuals and during pregnancy. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It carries product code LGD and is regulated under 21 CFR 866.3780 within the Microbiology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Access Toxo IgG
    Access Toxo IgM II
    Alinity i Toxo IgM
    ARCHITECT Toxo IgG
    Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
    ADVIA Centaur Toxoplasma M (Toxo M)
    LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
    LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
    VIDAS TOXO IGG AVIDITY
    ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
    PLATELIA TOXO IGM KIT MODEL 26211
    ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
    ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
    DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS
    ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
    ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
    BIO-RAD PLATELIA TOXO IGM TMB
    BIO-RAD PLATELIA TOXO IGG TMB
    IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
    BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
    BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
    ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
    ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
    DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
    VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
    THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F
    THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM
    ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
    IS-TOXOPLASMA IGG TEST SYSTEM
    QUANTA LITE TOXOPLASMA IGG
    TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
    SERAQUEST TOXOPLASMA IGM
    INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
    IMMULITE TOXOPLASMA QUANTITATIVE IGG
    TOXO IGG ELISA TEST
    INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
    INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
    AXSYM TOXO IGM
    AXSYM TOXO IGG ANTIBODY ASSAY
    TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM
    SERAQUEST TOXOPLASMA IGG
    TOXOSTAT
    IMMULITE TOXOPLASMA GONDII IGG
    ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
    IMX TOXO IGG
    IMX(R) TOXO IGM
    VIDAS TOXO COMPETITION (TXC) ASSAY
    VIDAS TOXO IG6 ASSAY (TX6)
    VIDAS TOXOPLASMA GONDII IGM ASSSAY
    OPUS(R) TOXO-G TEST SYSTEM

    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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