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510(k) Data Aggregation

    K Number
    K964574
    Device Name
    AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
    Date Cleared
    1997-01-21

    (68 days)

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

    ATHENA MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Affirm One-Step Professional Pregnancy Test is a rapid one-step visual test for the qualitative detection of human Chorionic Gonadotropin in human urine to aid in the diagnosis of pregnancy. This test is intended for Professional use.
    Device Description
    Affirm detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled to the reagent pad where the hCG reacts with the conjugate, and then through the membrane containing bound capture antibodies. Positive results are determined by one color line in the test window and one color line in the control window. The absence of hCG produces only one color line in the control window.
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    K Number
    K962888
    Device Name
    AFFIRM ONE-STEP HOME PREGNANCY TEST
    Date Cleared
    1996-09-23

    (61 days)

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

    ATHENA MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Affirm One-Step home pregnancy test is a rapid one-step visual test for the qualitative detection of human chorionic gonadotropin in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.
    Device Description
    Affirm detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by one color line in the test window and one color line in the control window. The absence of hCG produces only one color line in the control window.
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