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510(k) Data Aggregation

    K Number
    K043231
    Device Name
    PROOF POSITIVE ELECTRONIC PREGNANCY TEST
    Manufacturer
    MIZUHO USA, INC.
    Date Cleared
    2005-04-25

    (154 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

    Proof Positive Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the qualitative determination of human chorionic gonadotropin (hCG) in urine. The test will be marketed for the retail or "over-the-counter" (OTC) market use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "Proof Positive Electronic Pregnancy Test." While it states the device has been found substantially equivalent to a predicate device and provides its intended use, it does not contain specific information about acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment that would allow a comprehensive answer to your request. The letter is a regulatory approval, not a scientific study report.

    Therefore, I cannot extract the requested information from the provided text.

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