LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022352
    Device Name
    HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2002-08-28

    (40 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 :

    HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)

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

    HTF Plus with HEPES (HTF with non-essential amino acids) is used as a holding media for human gametes and embryos for assisted reproduction.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "HTF Plus with HEPES" (also referred to as "HTF with non-essential amino acids"). This letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

    The letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This means that for this particular device (a reproductive media and supplement), the FDA's decision is based on its similarity to existing products, rather than a new study demonstrating its efficacy against specific pre-defined acceptance criteria.

    Therefore, I cannot fulfill your request with the provided input. The information you are asking for typically comes from a detailed clinical study report or a different section of a 510(k) submission that outlines performance testing.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1