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510(k) Data Aggregation

    K Number
    K163144
    Device Name
    gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
    Manufacturer
    Date Cleared
    2017-04-07

    (149 days)

    Product Code
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    GKE-GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The qke Steam SCBI is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of nominal 100,000 spores of Geobacillus stearothermophilus on a carier and enclosed in a protective plastic vial. The spores have a known resistance to certain steam sterilization cycles. The device can be used for gravity and pre-vacuum cycles according to the following conditions: 121 °C, 30 minutes / 132, 134 and 135°C, 3 minutes. Subsequent growth or failure of the microorqanisms after an incubation time of 24 hours at 55-60 °C indicates the adequacy of sterilization.
    Device Description
    The gke Steri-Record Steam Mini-Bio-Plus SCBI uses a plastic vial with a minimized internal volume containing a biological indicator spore disc and a glass ampoule with a growth medium and pH-indicator inside. The growth medium is optimized to support growth.
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