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    K Number
    K252672

    Validate with FDA (Live)

    Device Name
    CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)
    Manufacturer
    Casebioscience, Inc.
    Date Cleared
    2026-02-20

    (179 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    K242107
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CaseBio™ Culture w/HSA is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.

    CaseBio™ Handling w/HSA is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity.

    Device Description

    CaseBio™ Culture w/HSA (CMH5) and CaseBio™ Handling w/HSA (WHH5) are intended for use during in vitro procedures for gamete/embryo culture and one step media.

    CaseBio™ Culture w/HSA is intended for use for culture of embryos from fertilization to the blastocyst stage. This device is a one-step media and can be used for transfer of embryos to the uterus.

    CaseBio™ Handling w/HSA is intended for use in short-term handling and manipulation of gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity.

    CaseBio™ Culture w/HSA (CMH5) and CaseBio™ Handling w/HSA (WHH5) have almost identical composition with differences in amount of NaHCO3 and Phenol red and presence of HEPES in CaseBio™ Handling w/HAS. Both formulations contain gentamicin and human serum albumin.

    The two solutions are aseptically filtered (storage vials sterilized by radiation) and provided in PETG square media bottles with HDPE screw-style caps. They have a shelf-life of 90 days when stored at 2-8°C. Media in the vials can be used for up to seven days after vial opening.

    AI/ML Overview

    N/A

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