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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?
    Product Code :

    JTY

    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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    K Number
    K993033
    Device Name
    INTRAY GC
    Manufacturer
    BIOMED DIAGNOSTICS, INC.
    Date Cleared
    1999-12-16

    (98 days)

    Product Code
    JTY
    Regulation Number
    866.2410
    Why did this record match?
    Product Code :

    JTY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.
    Device Description
    The InTray GC contains a Modified Thayer-Martin (MTM) medium within a sealed inner well. It has a two inch diameter well and 5-6ml of media. The inner seal that covers this well also covers another 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 reseals this outer label. In practice, when the user opens the outer seal, he may then remove and discard the inner seal exposing the surface of the medium and the sealed cavity. The next step is to inoculate the surface of the medium with the patient sample. Next, puncture the seal over the cavity with any convenient sharp point. Finally, reseal the outer label over the InTray. High humidity within the InTray causes the tablet to generate CO2. Incubate the InTray and observe the growth of organisms through the window without opening the InTray and therefore without disturbing the atmosphere. Observation can be by eye, hand lens or microscope. This packaging has been used since 1994 for other BioMed media products.
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    K Number
    K954986
    Device Name
    GC BASE W/ 1% GCHI
    Manufacturer
    REMEL, L.P.
    Date Cleared
    1996-02-16

    (108 days)

    Product Code
    JTY
    Regulation Number
    866.2410
    Why did this record match?
    Product Code :

    JTY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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