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The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.

The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60°C for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat. There are no changes to the strip itself for this submission; only an expansion to the exposure time to the chemical sterilant.

The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.

The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60℃ for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.

The VERIFY® Spore Test Strip for S40 Sterilant is intended to provide users with a means to assess spore kill by S40 sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10E5 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.

The VERIFY® Spore Test Strip for S40 Sterilant consists of a 1 36 in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the liquid chemical sterilant processor. The transfer clip thus holds the Spore Test Strip in a fixed location during a processing cycle in the STERIS Liquid Chemical Sterilant Processing System and enables aseptic transfer of the strip from the processor into the growth media vial after the cycle ends. For use, the Spore Test Strip is removed from the glassine envelope and secured using the transfer clip in the SYSTEM 1E Liquid Chemical Sterilant Processing System or SYSTEM 1 endo Liquid Chemical Sterilant Processing System along with the items to be liquid chemically sterilized. The liquid chemical sterilization cycle is initiated. At the end of the full cycle, the Spore Test Strip is removed and placed into the vial of growth medium for incubation under the specified conditions that will promote spore growth for at least 24 hours. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The Spore Test Strip is incubated at 55-60°C for a minimum of 24 hours, but may be incubated for up to 7 days. The shelf life is 12 months when stored at 2-24℃ and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat. The current submission makes no changes to the strip itself; only the indications for use are changing to encompass the VERIFY Spore Test Strip's broader use in more than one STERIS automated liquid chemical sterilant processing system (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System) that uses S40 Sterilant Concentrate under identical exposure conditions.

The Steris Verify Spore Test Strip for S40 is intended to provide users with a means to assess spore kill by the S40 sterilant at its use dilution in the System 1E Liquid Chemical Sterilant Processing System. A "no growth" result from the Steris Verify Spore Test Strip for S40 after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10 viable spores (5 logs) on the test strip. The Steris Verify Spore Test Strip for S40 does not confirm the expected full performance of the SYSTEM 1E Liquid Chemical Sterilization Cycle.

The Steris Verify Spore Test Strip for S40 consists of a 1 3/8 in x ¼ in filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip holds the Spore Test Strip in a single location during a processing cycle in the System 1E Liquid Chemical Sterilant Processing System (System 1E processor; cleared under K090036) and enables aseptic transfer of the Strip from the processor into the growth media vial. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the System 1E processor.