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510(k) Data Aggregation

    K Number
    K251040
    Date Cleared
    2025-09-09

    (159 days)

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

    MissLan® Early Detection Digital Pregnancy Test is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

    MissLan® Early Result Digital Pregnancy Test is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

    Device Description

    The MissLan® Early Detection Digital Pregnancy Test and the MissLan® Early Result Digital Pregnancy Test are both over-the-counter (OTC) digital pregnancy tests with a sensitivity of 10 mIU/mL hCG. They are powered by battery and display test results on an LCD screen. The MissLan® Early Detection Digital Pregnancy Test displays test results with graphic symbols, including "+" (pregnant), "-" (not pregnant) and " " (invalid); the MissLan® Early Result Digital Pregnancy Test displays test results with text, including "Pregnant", "Not Pregnant" and "Error".

    AI/ML Overview

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