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510(k) Data Aggregation

    K Number
    K032161
    Device Name
    PHEM-ALERT
    Manufacturer
    FEMTEK,LLC.
    Date Cleared
    2003-09-30

    (77 days)

    Product Code
    LNW
    Regulation Number
    862.1550
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K012230
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The pHEM-ALERT® test measures vaginal pH and is intended for use by women who have any of the following vaginal symptoms: Itching - Burning - Unpleasant odor - Unusual discharge This test may help decide if these symptoms are caused by an infection that may require follow-up by your healthcare provider. This test is only intended for women who have normal menstrual periods (periodic vaginal bleeding) or who may currently be pregnant. If you are pregnant, always discuss your symptoms and the result of this test with your healthcare provider and NEVER treat yourself.

    Device Description

    The pHEM-ALERT provides a method for the lay user to measure her vaginal pH. The pHEM-ALERT test is comprised of a plastic probe with pH paper on one end, a color chart and a package insert. The plastic probe is in the shape of small flat key. pHEM-ALERT is indicated for measuring vaginal pH for the purpose of differentiating normal and abnormal conditions in symptomatic women. The device is inserted into the vagina and the measurement taken.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    The document is a 510(k) summary for the pHEM-ALERT device. It focuses on:

    • Sponsor and device identification: FemTek, LLC, and the pHEM-ALERT.
    • Predicated device: The previously cleared pHEM-ALERT (K012230).
    • Indications for Use: What the device is intended for (measuring vaginal pH for symptomatic women, including pregnant women).
    • Device Description: A plastic probe with pH paper, a color chart, and a package insert.
    • Reason for submission: Changes to the package insert regarding a warning about STDs and allowing use by pregnant women.
    • FDA correspondence: The FDA's letter of substantial equivalence, confirming that the device can be marketed.

    This 510(k) specifically concerns modifications to labeling for an already cleared device, not a new device requiring performance studies to establish its effectiveness against acceptance criteria. Therefore, the detailed information requested about a study and acceptance criteria (sample size, ground truth, experts, etc.) is not present in this document.

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