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510(k) Data Aggregation

    K Number
    K061008
    Device Name
    QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
    Manufacturer
    QUIDEL CORP.
    Date Cleared
    2006-09-08

    (149 days)

    Product Code
    MCE
    Regulation Number
    866.3480
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    Product Code :

    MCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.
    Device Description
    Nasopharyngeal swabs, nasopharyngeal aspirate and/or nasal washes serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 15 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains RSV antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If RSV viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.
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