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510(k) Data Aggregation

    K Number
    K233413
    Device Name
    Ultraphon Chemical Indicator (TRO-T and TRO-B)
    Date Cleared
    2024-06-26

    (264 days)

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

    True Indicating LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution. The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® EPR and trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® EPR and trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
    Device Description
    The device is a qualitative, single use, disc (26 mm in diameter) that has a hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek® substrate (Product Code: TRO-T) or polypropylene substrate (Product Code: TRO-B). The hydrogen peroxide sensitive chemical indicating ink has been designed to transition from an initial red color to a signal yellow color when subjected to sources of hydrogen peroxide.
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    K Number
    K220778
    Device Name
    Chemical Indicator for Steam
    Date Cleared
    2022-12-02

    (260 days)

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

    True Indicating LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods. The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators: Gravity: 121°C/250 F - 30 minutes (wrapped/porous) Pre-vacuum: 132℃/270 F - 3 minutes (unwrapped/nonporous) Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous) Pre-vacuum: 134℃/273 F - 4 minutes (wrapped/porous) Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)
    Device Description
    The True Indicating Lead-Free Chemical Indicator for Steam product codes CSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue to dark), all turn a permanent dark brown/black color when exposed to high temperature steam. Paper Strip printed with Bismuth based chemical indicator ink with polyester overlaminate applied over the entire indicating ink strip
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    K Number
    K210481
    Device Name
    Instant 20s Indicator
    Date Cleared
    2021-12-14

    (298 days)

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

    True Indicating LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3 minutes (Pre-Vacuum).
    Device Description
    The True Indicating Instant 20s Indicator consists of a polycarbonate vial, polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant, and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953.
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    K Number
    K200970
    Device Name
    Self-Contained Biological Indicator
    Date Cleared
    2020-12-28

    (259 days)

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

    True Indicating LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The True Indicating Self-Contained Biological Indicator is intended for monitoring the efficacy of saturated steam sterilization processes. The True Indicating Self-Contained Biological Indicator has a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre-Vacuum), and 135°C, 3 minutes (Pre-Vacuum).
    Device Description
    The True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 - mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple.
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