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    K Number
    K191063
    Device Name
    1-Step Culture Medium
    Manufacturer
    Shenzhen VitaVitro Biotech Co., Ltd.
    Date Cleared
    2019-08-23

    (123 days)

    Product Code
    MQL,MOL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K133568
    Why did this record match?
    Device Name :

    1-Step Culture Medium

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

    This product is intended for the in vitro culture of human embryos following fertilization until Day 5/6 of development.

    Device Description

    VitaVitro® 1-Step Culture Media product intended for the in vitro culture of embryos from fertilization until day 5/6 of development. It is an aseptically filtered, bicarbonate-buffered media containing physiological salt solutions, gentamicin, and human serum albumin. It is ready to use after warming to 37°C and equilibration in a CO2 environment.

    AI/ML Overview

    The provided text describes the acceptance criteria and the studies performed for the VitaVitro® 1-Step Culture Medium. Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    AspectAcceptance Criteria (Specification)Reported Device Performance (Summary of results from non-clinical testing)
    Sterility (per USP )No microbial growthMet (Implied by conclusion of substantial equivalence based on testing)
    Osmolality250 – 290 mOsm/kgMet (Implied by conclusion of substantial equivalence based on testing)
    pH7.2 — 7.6Met (Implied by conclusion of substantial equivalence based on testing)
    Endotoxin (per USP )
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