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510(k) Data Aggregation

    K Number
    K040530
    Device Name
    MEDIA CULTURE SYSTEM
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2004-06-25

    (116 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDIA CULTURE SYSTEM

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

    HTF with HEPES is used as a holding media for human gametes and embryos for assisted reproduction. global with HEPES is used as a holding and transfer medium for human gametes and embryos for assisted reproduction. PGD Biopsy Media is used as a holding medium for human gametes and embryos for assisted reproduction during the cell biopsy procedure used for pre-implantation genetic diagnosis.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

    The document is a 510(k) clearance letter from the FDA for reproductive media. It confirms that the devices (HTF with HEPES, Global with HEPES, and PGD Biopsy Media) are substantially equivalent to legally marketed predicate devices.

    While it states that the FDA reviewed a "premarket notification of intent to market the device," it does not include the details of any specific study, acceptance criteria, or performance data. Such information would typically be found within the 510(k) submission itself, not in the clearance letter.

    Therefore, I cannot populate the table or provide answers to the questions regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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