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510(k) Data Aggregation

    K Number
    K112083
    Device Name
    LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2012-05-03

    (287 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 :

    LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES

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

    LifeGlobal Global Total: Culture of human embryos from zygote to blastocyst, and embryo transfer

    LifeGlobal Global Total for Fertilization: Human oocyte culture and fertilization

    LifeGlobal Global Total w/HEPES: Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a reproductive media device, not an AI/ML device.

    The letter confirms substantial equivalence but does not describe the specific performance studies, acceptance criteria, or ground truth methodologies that would be relevant for an AI/ML product. The document focuses on regulatory compliance and classification of a medical device (reproductive media), not on the evaluation of an AI algorithm's performance.

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