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510(k) Data Aggregation

    K Number
    K091287
    Device Name
    VS-SENSE TEST
    Manufacturer
    COMMON SENSE, LTD.
    Date Cleared
    2009-08-31

    (122 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMMON SENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VS-SENSE™ TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms. The device is a vaginal pH indicator swab intended to be used in conjunction with other clinical examinations, such as the Amsel criteria or the Nugent Gram stain, to aid in determining conditions characterized by elevated vaginal pH, such as bacterial vaginosis.
    Device Description
    The VS-SENSE™ comprises a regular vaginal swab with its tip coated by an indicating polymer. When the indicating tip has been in contact with vaginal secretion, with elevated pH level, the user will observe a blue or green stain on the yellow background of the tip. The stains on the tip are caused by the sensitivity of a proprietary polymer, which coats the tip and contains the traditional indicator - Nitrazine Yellow. The VS-SENSE™ polymer matrix has a specific composition of ingredients that changes color when the pH of the vaginal discharge is greater than 4.7 +0.3/-0.2.
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    K Number
    K071100
    Device Name
    AMNISCREEN HOME DETECTION LINER KIT
    Manufacturer
    COMMON SENSE, LTD.
    Date Cleared
    2007-10-15

    (179 days)

    Product Code
    CEN
    Regulation Number
    862.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMMON SENSE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AmniScreen Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.
    Device Description
    The AmniScreen™ Home Detection Liner Kit contains a Testing Panty-Liner (TPL) and a Drying Tray (DT). The TPL comprises a regular panty-liner and an indicator strip assembled into the panty-liner, covered with two layers of one-way perforated film. The indicator strip is removed after use and placed in the DT for 30 minutes before reading the test results. When the indicator strip has been in contact with amniotic fluid, the user will observe a blue-green stain on the yellow background of the strip. An elevated pH level of the fluid causes the stain. The stains on the strip are caused by the sensitivity of a proprietary polymer, which coats the strip and contains the traditional indicator - Nitrazine Yellow, to pH levels above 5.2 units. The proprietary polymer is also sensitive to certain concentrations of ammonium in the tested fluid, and when the color changes are created by fluids with a certain concentration level of ammonium, and pH levels up to 7.0 units, these color changes are reversible and during a drying period of 30 minutes the blue-green stains fade back to yellow.
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