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510(k) Data Aggregation

    K Number
    K981263
    Device Name
    TOXOGEN
    Date Cleared
    1998-08-06

    (121 days)

    Product Code
    Regulation Number
    866.3780
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    Product Code :

    GMM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The test may be used with a single specimen to estimate the immunologic response of the individual or with paired acute and convalescent sera as an aid in the diagnosis of primary, acute or reactivated toxoplasmosis. This assay is not FDA cleared for use in blood or plasma donor screening.
    Device Description
    Toxogen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total anti-toxoplasma antibodies in human serum. The new Toxogen is a modified version of the predicate Toxogen with a larger latex particle size to increase sensitivity from 10 IU/mL to 5 IU/mL.
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