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510(k) Data Aggregation
K Number
K163144Device 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
880.2800Why 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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