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The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes. | Cycle Type | Temperature | Time | |---------------------|---------------|------------| | Dynamic Air Removal | 270°F (132°C) | 4 minutes | | Dynamic Air Removal | 275°F (135°C) | 3 minutes | | Gravity | 250°F (121°C) | 30 minutes | | Gravity | 270°F (132°C) | 15 minutes | When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes

The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

The VERIFY™ Assert™ STEAM Process Challenge Device (PCD) is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include: - 270°F (132°C) 4-minute dynamic air removal - 275°F (135°C) 3-minute dynamic air removal

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The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes. | Cycle Type | Temperature | Time | |---------------------|---------------|------------| | Dynamic Air Removal | 270°F (132°C) | 4 minutes | | Dynamic Air Removal | 275°F (135°C) | 3 minutes | | Gravity | 250°F (121°C) | 30 minutes | | Gravity | 270°F (132°C) | 15 minutes | When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.

The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert Self-Contained Biolgoical Indicator in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.

The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.