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510(k) Data Aggregation

    K Number
    K151482
    Device Name
    BCR-30-min BI™ and RBIP-ST30™ Readout Accessory
    Date Cleared
    2016-02-26

    (269 days)

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

    BCR DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Use the BCR-30-min BI™ and the RBIP-ST30™ together for monitoring performance of gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C). The BCR-30-min BI™ in conjunction with the RBIP-ST30™ provides final fluorescence results in 30 minutes.
    Device Description
    The BCR-30-min BI™ is designed to be used with its readout accessory, the RBIP-ST30™ robotic processor, for validating and challenging performance of gravity displacement steam sterilization cycles at 250°F (121°C). The BCR-30-min BI™ consists of a strip (6.0 x 60 mm) of filter paper (Whatman GF/A) inoculated in the center with about 106 living spores of Geobacillus stearothermophilus ATCC No. 7953. The strip is packaged in a #30 blue glassine pouch (1 x 3 inch). The BCR-30-min BI™ should be placed in the center of the load or in the most difficult to sterilize area. In the RBIP-ST30™, the spores of the BCR-30-min BI™ are first converted into Fspores™ and then they are incubated for 30 min at 55±2°C to allow germination of living Fspores™. The device utilizes the fact that F-spores™ are not fluorescent per se but produce intense fluorescence when germinated. Accordingly, the RBIP-ST30™ detects failure of a steam sterilization cycle when significant fluorescence is present. The RBIP-ST30™ is designed to automatically process the BCR-30-min BI™ to obtain a fluorescence reading within 30 minutes.
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