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510(k) Data Aggregation

    K Number
    K983886
    Device Name
    POCKIT HSV 2 RAPID TEST
    Manufacturer
    DIAGNOLOGY LTD.
    Date Cleared
    1999-08-19

    (290 days)

    Product Code
    LGC
    Regulation Number
    866.3305
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state.
    Device Description
    The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human capillary whole blood and serum. The POCkit™ HSV-2 Rapid Test consists of a lest device that has a solid phase membrane housed in a plastic envelope containing wicking material. The membrane is visible to the user through a test window on the front of the device. The method employs a unique combination of a specific antibody binding protein conjugated to colloidal gold particles and a semi-purified HSV-2 specific antigen (glycoprotein G2, derived from HSV-2 virus). This protein has been bound to the membrane as a TEST spot on the right side of the test window. Human IgG has been bound to the membrane as a CONTROL spot on the left side of the test window. When a pro-diluted (fingerprick) capillary whole blood sample is allowed to pass through the membrane any anti-HSV-2 antibodies present become bound to the HSV-2 antigen in the TEST spot. Upon addition of the developing reagent, which reacts with human IGG antibodies, a pink/red color develops. The developing reagent also reveals the human IgG immobilized in the CONTROL spot, which demonstrates that the test is functioning property. The test device is designed to absorb the pro-calibrated volume of reagents that are provided in each test kit.
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