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510(k) Data Aggregation

    K Number
    K981207
    Device Name
    CLEARPLAN EASY FERTILITY MONITOR
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    1998-10-28

    (209 days)

    Product Code
    NGE,CEP,LHD
    Regulation Number
    862.1485
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K012252,K020808
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy.

    The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.

    The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility.

    CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.

    CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.

    Device Description

    The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman's cycle on which intercourse is most likely to lead to conception. The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility. CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.

    AI/ML Overview

    This is a Premarket Notification (510(k)) for the Clearplan Easy Fertility Monitor, indicating substantial equivalence to a predicate device. This document primarily focuses on regulatory approval and indications for use, without detailing specific performance studies or acceptance criteria for the device itself.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text. The document is a regulatory approval letter, not a detailed study report.

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