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510(k) Data Aggregation

    K Number
    K021789
    Device Name
    QUICKLAB RSV
    Date Cleared
    2002-11-20

    (173 days)

    Product Code
    Regulation Number
    866.3480
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRATED BIOTECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The QuickLab RSV™ Test is intended for the qualitative detection of Respiratory Syncytial Virus antigens (fusion protein) directly from nasopharyngeal swab, and nasal aspirate specimens in children less than 6 years and adults over the age of 60. The QuickLab RSV test is intended for use as an aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with symptoms consistent with an RSV infection. It is recommended that negative results be confirmed by cell culture.
    Device Description
    The QuickLab RSV is a lateral flow immunogold assay for the direct visual detection of RVS protein F in clinical samples. The basis for protein F detection is in the use of a red - colored gold labeled mouse monoclonal anti-RSV protein F antibody that after addition of extracted sample travels laterally along the strip test device membrane. This lateral flow carries the mixture of sample and qold-labeled anti- RSV protein F through a membrane adsorbed monoclonal anti-RSV protein F Test Line (T) and then through a membrane adsorbed goat anti-mouse immunoglobulin Control Line (C). When RSV protein F is present in clinical samples, the fluid phase mouse anti-RSV protein F binds this antigen and this formation of antigen - antibody complex is then in turn bound at the Test Line (T). The unbound or excess mouse anti - RSV protein F passes through the Test Line (T) and is bound at the Control Line (C) by goat antimouse immunoalobulin. Therefore, in the presence of RSV protein F antigen, 2 red lines become visible: one at the Test Line (T) and a second at the Control Line (C). But when RSV antigen is absent only one red line appears at the Control Line (C).
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