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510(k) Data Aggregation

    K Number
    K140455
    Device Name
    CAPTIA MEASLES IGM
    Manufacturer
    TRINITY BIOTECH USA
    Date Cleared
    2014-05-22

    (87 days)

    Product Code
    PCL
    Regulation Number
    866.3520
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    Product Code :

    PCL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of Measles IgM antibodies in human serum of patients suspected of measles (rubeola) infection. This assay is intended for use as an aid in the diagnosis of a current or recent measles (rubeola) infection in conjunction with other clinical information and laboratory findings. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at a point of care. This test is not intended for use in screening blood and plasma donors.
    Device Description
    The Trinity Biotech Captia™ Measles IgM test is an Enzyme-Linked Immunosorbent Assays (ELISA). When measles antigen (Edmonston strain) is bound to the solid phase and brought into contact with a patient's serum, antigen specific antibody, if present, will bind to the antigen on the solid phase forming antibody complexes. Excess antibody is removed by washing. This is followed by the addition of goat anti-human IgM globulin conjugated with horseradish peroxidase which will bind to the antibody-antigen complexes. The excess conjugate is removed by washing, followed by the addition of Chromogen/Substrate tetramethylbenzidine (TMB). If specific antibody to the antigen is present in the patient's serum, a blue color develops. When the enzymatic reaction is stopped with 1N H2SO4. The contents of the wells turn yellow. The color, which is indicative of the concentration of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader.
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