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510(k) Data Aggregation

    K Number
    K953606
    Device Name
    BEST PREGNANCY TEST
    Manufacturer
    AMERITEK, INC.
    Date Cleared
    1996-03-22

    (233 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Home pregnancy test kits can now be purchased from most drug stores without a prescription.

    Device Description

    One step Best midstream presnancy test kids detect pregnancy by an immunologically reaction. The antibodies are affinity purified Goat anti mouse IgG, affinity purified polyclonal antibody to HCG and affinity purified monoclonal antibody to HCG.

    AI/ML Overview

    Here's an analysis of the provided text in the context of acceptance criteria and study design, structured to address your specific points:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Accuracy (Pregnant women)100%
    Cross-reactivity with LH (at
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