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510(k) Data Aggregation

    K Number
    K183097
    Device Name
    Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
    Date Cleared
    2019-01-10

    (64 days)

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

    Weihai Kangzhou Biotechnology Engineering Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kangzhou One Step hCG Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use. The Kangzhou One Step hCG Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use. The Kangzhou One Step hCG Test Midstream is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is intended for over-the-counter (OTC) use.
    Device Description
    The Pregnancy One Step Rapid Test is a qualitative, solid phase, two-site sandwich immunoassay for the detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. The membrane is pre-coated with anti-hCG antibodies on the test band region and anti-mouse antibodies on the control band region. During testing, the urine sample reacts with the dye conjugate (mouse anti-hCG antibody-colloidal gold conjugate) which has been pre-coated on the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action to react with anti-hCG antibodies on the membrane and generate a red band. Presence of the red band indicates a positive result, while its absence indicates a negative result. Regardless of the presence of hCG, as the mixture continues to migrate across the membrane to the immobilized goat anti-mouse region, a red band at the control band region will always appear. The presence of this red band serves as verification for sufficient sample volume and proper flow and as a control for the reagents.
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