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510(k) Data Aggregation

    K Number
    K023823
    Device Name
    EASYCUP
    Manufacturer
    Date Cleared
    2003-05-22

    (188 days)

    Product Code
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZER HITECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is indicated for use for the early detection of pregnancy to measure HCG, a placental hormone, in urine. The Zer EasyCup is indicated for use for the early detection of pregnancy to qualitatively measure HCG, a placental hormone, in urine. It is intended to be sold over the counter (OTC) and for professional use, and to be used directly by consumers at home, doctor's offices, laboratories, and hospitals.
    Device Description
    hCG EASYCUP PREGNANCY TEST is a rapid one-step test for a visual qualitative detection of human Chorionic Gonadotropin (hCG) in urine. hCG (Human Chorionic Gonadotropin) is a glycoprotein hormone, secreted by the fertilized ovum shortly after fertilization. In normal pregnancies, hCG can be determined in urine as early as ten days following conception. hCG makes an excellent marker for the early detection of pregnancy, as it appears in urine soon after conception. Its concentration in urine increases rapidly during early gestational growth. A nitrocellulose membrane is placed on a plastic backing. Two lines of antibodies are drawn on the membrane. One line, which is the test line, is coated with anti-x hCG. The other line, which serves as a control line, is pre-coated with anti-mouse IgG. A pad, soaked with anti-B hCG antibodies conjugated to colloidal gold particles, is placed on the membrane. Both sides of the membrane are covered with absorbing paper. When the sample is positive (above 20 mIU/ml) the liquid moves through the pad of the anti-ß antibodies. The antibodies bind the B subunit of the hormone. This complex labeled with gold moves through the membrane. When it arrives to the anti-x antibodies capture the complex by the a subunit of the hormone. The test line then becomes pink. When the rest of the gold conjugated antibodies reach the control line, the antilodies capture, non specifically, the gold conjugated anti-B hCG antibodies, a second pink line is formed. A negative sample (hCG below 20 mIU/ml) will not create a complex of gold labeled antibodies and hormone molecules, and no pink test line will form. A colored control line will always appear resulting from the viability of the antibodies.
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