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510(k) Data Aggregation

    K Number
    K042280
    Device Name
    FACT PLUS ONE-STEP PREGNANCY TEST KIT
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-09-10

    (18 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FACT PLUS ONE-STEP PREGNANCY TEST KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fact plus® One-Step Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from four days before the expected period.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the "Fact plus® One-Step Pregnancy Test." It grants clearance for marketing but does not contain detailed information about the acceptance criteria, study design, or performance metrics beyond the general intended use. Therefore, I cannot extract the requested information from this document.

    To answer your questions, I would need access to the actual 510(k) submission document or a summary of the clinical studies conducted for this device. The provided text is a regulatory approval, not a scientific study report.

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