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510(k) Data Aggregation
K Number
K233413Device Name
Ultraphon Chemical Indicator (TRO-T and TRO-B)
Manufacturer
Date Cleared
2024-06-26
(264 days)
Regulation Number
880.2800Why 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
K220778Device Name
Chemical Indicator for Steam
Manufacturer
Date Cleared
2022-12-02
(260 days)
Regulation Number
880.2800Why 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
K210481Device Name
Instant 20s Indicator
Manufacturer
Date Cleared
2021-12-14
(298 days)
Product Code
Regulation Number
880.2800Why 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
K200970Device Name
Self-Contained Biological Indicator
Manufacturer
Date Cleared
2020-12-28
(259 days)
Product Code
Regulation Number
880.2800Why 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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