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510(k) Data Aggregation

    K Number
    K041039
    Device Name
    FERTELL MALE FERTILITY TEST
    Manufacturer
    GENOSIS LTD.
    Date Cleared
    2004-07-20

    (89 days)

    Product Code
    POV, GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENOSIS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for home use. The Fertell Male Fertility Test is intended to measure motile sperm in semen as an adjunctive screen of male fertility for over-the-counter (OTC) home use.
    Device Description
    The Fertell Male Fertility Test measures the concentration of progressively motile sperm in a fresh semen sample. The test is performed between two and seven days after the last ejountion. Semen is collected directly into a custom design collection container and allowed to liquefy for 30 minutes. A test unit is then positioned onto the liquefied sample and the pressing of a button releases a solution of sodium hyaluronate buffer solution over the semen sample and stats heating the fluid to 37℃. Motile sperm swim-up through the sodium hyaluronate for 30 minutes before a valve is opened, by turning a knob, allowing the buffer solution, and motive 50 mm present, to flow along a capillary channel. Anti-CD59 monoclonal antibody that is conjugated with colloidal gold is released from an absorbent pad in the channel and reacts with the sperm forming an immunocomplex of gold-labeled sperm. The fluid containing this complex flows onto a nitrocellulose strip where the gold-labeled sperm are trapped, forming a realine. Unreacted conjugate is washed from the strip by the flow of excess buffer. Turning the knob back to its original position closes the valve and reveals the test result. The appearance of a clear red line (test result) indicates motile sperm in the semen sample at a concentration of≥10M/mL. This level is indicative of normally expected motile sperm concentrations. The device has a microprocessor to control internal fluid temperature at 37° C and provide user prompts by an LED that changes state at the end of each timed activity. A control line is present on the nitrocellulose test strip to confirm to the user that the test has functioned correctly.
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