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510(k) Data Aggregation

    K Number
    K210511
    Device Name
    InTray GC
    Manufacturer
    Biomed Diagnostics Incorporated
    Date Cleared
    2021-10-20

    (239 days)

    Product Code
    JTY
    Regulation Number
    866.2410
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biomed Diagnostics Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InTray GC is a microbiological device intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae when incubated at 35°C for 24-72 hours. Inoculated samples can optionally be pre-incubated prior to transport when pre-incubated at 35°C for 24 hours. Subsequent transport, of the pre-incubated specimen under controlled room temperature (18 to 25°C), is supported out to 72 hours.
    Device Description
    The InTray GC is a Modified Thayer-Martin medium within a sealed inner well. The inner seal covers the inner well containing agar and an additional sealed cavity containing a CO2 generating tablet. There is also an outer adhesive label seal with a window that does not fog up under 100% relative humidity. The user opens and inoculates the surface of the medium with the patient sample followed by resealing the outer adhesive label. High humidity within the InTray causes the tablet to generate CO2 thus providing adequate bacterial growth condition for the target pathogen. After incubation of the inoculated InTray, the bacterial growth can be observed through the window without opening the InTray and therefore not disturbing the established CO2 concentration. Observation of culture growth can be by eye, hand lens or microscope.
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