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510(k) Data Aggregation

    K Number
    K150063
    Device Name
    One Step hCG Pregnancy Test
    Manufacturer
    Date Cleared
    2015-10-02

    (262 days)

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

    Coretests, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use. ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use. ACCU NEWS One Step Pregnancy The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.
    Device Description
    ACCU NEWS "M One Step hCG Pregnancy Test is a qualitative lateral flow test for the detection of hCG (human chorionic gonadotropin) hormone, which is present in urine during the early stage of pregnancy. It is built on a basic lateral flow immunoassay test strip model containing 6 components as illustrated below: The nitrocellulose membrane is coated with Goat anti-mouse IgG polyclonal antibody on the control line and anti-alpha hCG mouse monoclonal antibody on the test line. The conjugate pad contains colloidal-gold-labeled anti-beta mouse monoclonal hCG antibody. When urine specimen is drawn through the sample pad, the hCG present in the urine will react with the anti-beta monoclonal hCG antibody on the conjugate pad and the antialpha monoclonal hCG antibody on the test line to develop visible lines in the test region. The ACCU NEWS TM One Step hCG Pregnancy Test is available in three different formats: 1) strip, 2) cassette, and 3) midstream.
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