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510(k) Data Aggregation

    K Number
    K970373
    Device Name
    RAICHEM RHEUMATOID FACTOR SPIA
    Date Cleared
    1997-04-17

    (73 days)

    Product Code
    Regulation Number
    866.5775
    Why did this record match?
    Applicant Name (Manufacturer) :

    HENAGE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A latex agglutination assay intended for the quantitative turbidimetric detection of Rheumatoid IgM antibodies in human serum and plasma. When used according to instructions, the assay is useful in establishing the presence of rheurmatoid factor and as an aid in the diagnosis and management of rheumatoid arthritis.
    Device Description
    Raichem's Rheumatoid Factor SPIA ™ latex agglutination assay is a quantitative turbidimetric assay for the detection of Rheumatoid Factor IgM antibodies in human serum and plasma. In this assay, latex microspheres coated with human and rabbit IgG are diluted in a medium, usually, designed to allow aggregation without rapid settling of Rheumatoid Factor complexed microparticles. As aggregates form, the suspension becomes less cloudy, resulting in less light being absorbed. The change in optical density is proportional to the amount of RF present in the suspension. A quantitative determination of the amount of RF present in a serum/plasma sample is made by comparison to a standard curve.
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