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510(k) Data Aggregation

    K Number
    K990262
    Device Name
    CLEARPLAN EASY HOME PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    1999-04-07

    (70 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

    The CLEARPLAN EASY Home Pregnancy Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women to detect pregnancy via a urine test. The CLEARPLAN EASY Home Pregnancy Test is a qualitative test which detects the hormone human chorionic gonadotropin (hCG) in urine. The product will be made available over-the-counter through pharmacies and drug stores.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a home pregnancy test. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the format requested. The document is primarily a regulatory approval letter. Therefore, I cannot extract the detailed information requested in your prompt.

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