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Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification processes.

Terragene Bionova® Reader Incubators (10/20FRLCD, Mini-Bio) incubate at 60° C and 37° C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 106 Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes.

The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %, SV37°C/75 min., SV54°C/30 min, SV55°C/28 min.

Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met.

Terragene Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Ranid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C.

Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to vellow for CD42 to indicate that the conditions of the cycle have been met.

The integrator Terragene Integron® TT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.

The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121°C for 30 minutes, 132°C for 15 minutes, 135°C for 25 minutes, 135°C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min..

Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the effication processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met.

Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam.

Terragene Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

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This document describes the FDA's acceptance of a premarket notification for sterilization process indicators, not an AI-powered medical device. Therefore, the provided text does not contain the information required to answer your request about acceptance criteria and a study proving an AI device meets those criteria.

The document discusses:

• Medical devices: Terragene Bionova® SCBI, Terragene Bionova® PCD, Terragene Bionova® Reader Incubators, Terragene Integron®, Terragene Chemdye®, Terragene Cintape®.
• Purpose: Monitoring the efficacy of various sterilization processes (steam, ethylene oxide, vaporized hydrogen peroxide).
• Regulatory status: Class II medical devices, subject to general controls.
• Indications for Use: Detailed descriptions of what each device monitors and how it indicates sterilization efficacy (e.g., color changes, fluorescence read times).

There is no mention of AI, algorithms, human readers, or expert consensus on AI performance, which are all key elements of your request.

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