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510(k) Data Aggregation

    K Number
    K100596
    Device Name
    CRYOPETTE
    Manufacturer
    MID-ATLANTIC DIAGNOSTICS, INC.
    Date Cleared
    2010-12-06

    (279 days)

    Product Code
    MQK,MOK
    Regulation Number
    884.6160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K041562
    Why did this record match?
    Device Name :

    CRYOPETTE

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

    The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

    Device Description

    The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacement bulb attached to one end of the cryostraw whose function is to aspirate and dispense the sample contained in the vitrification media in and out of the opposite (open) end of the cryostraw. The cryostraw is the only sample contacting portion of the Cryopette. The metering sheath provides structural rigidity for the Cryopette. The support ring provides a backstop and seal for the displacement bulb. The outer case encases the displacement bulb to provide a surface for labeling. The sealing mark, distal storage border and proximal storage border reference lines are found on the outside of the cryostraw.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance data for the Cryopette device. Here's a summary of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Mouse Embryo Assay (MEA): >70% hatching at 96 hoursHatching percentage well exceeded >70% at 96 hours (exact value not specified, but stated as "well exceeded")
    Endotoxin (LAL) Levels:
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