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510(k) Data Aggregation

    K Number
    K030058
    Device Name
    EARLYDETECT MENOPAUSE TEST FOR FSH
    Manufacturer
    EARLY DETECT, INC.
    Date Cleared
    2003-07-30

    (204 days)

    Product Code
    CGJ
    Regulation Number
    862.1300
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EARLY DETECT, INC.

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

    EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.

    Device Description

    Rapid Membrane ImmunoAssay

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the EarlyDETECT® MENOPAUSE TEST. This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can, therefore, be marketed subject to general controls provisions. It specifies the device name, regulation number, regulation name, and product code, along with its intended use as a qualitative rapid membrane immunoassay for in vitro diagnostic detection of follicle-stimulating hormone (FSH) in human urine for confirming hormone changes related to menopause, intended for professional and Over-The-Counter (OTC) use.

    Therefore, I cannot provide the requested information based on the text provided. A separate submission, often referred to as the 510(k) summary or the full 510(k) submission, would typically contain such detailed study information.

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