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510(k) Data Aggregation
K Number
K231383Device Name
Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Manufacturer
Terragene SA
Date Cleared
2024-09-18
(495 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Terragene SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).
BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃.
Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).
The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® 100NX Sterilization System (Standard and Express cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer ( cycle 1 ).
- · LowTem Crystal 120 Sterilizer (Standard cycle).
The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
Device Description
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K Number
DEN220042Device Name
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
Manufacturer
Terragene SA
Date Cleared
2024-07-12
(742 days)
Product Code
QVB, OVB
Regulation Number
880.2806Why did this record match?
Applicant Name (Manufacturer) :
Terragene SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Terragene® Bionova® Photon Biological Indicator (BT225) is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 100 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes. BT225 SCBI is not recommended and should not be used for qualification testing purposes. On each Terragene® Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.
- Gravity-displacement Steam Sterilization Cycles 132 °C, 25 minutes 132 °C, 15 minutes 132 °C, 10 minutes 135 ℃, 10 minutes
- Dynamic-air-removal Steam Sterilization Cycles 132 °C. 4 minutes 135 °C, 3 minutes
Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60 ℃ and reads the Terragene® Bionova® Photon SCBIs at the times prescribed in the User Manual.
Device Description
Terragene® Bionova® Photon Biological Indicator (BT225) is a Biological Indicator for monitoring gravity-displacement and dynamic-air-removal steam sterilization cycles at 132 °C -135 ℃. When BT225 is used in conjunction with the Terragene® Bionova® Photon Auto-reader Incubator (BPH), it provides a final fluorescent result at 7 seconds.
Terragene® Bionova® Photon Biological Indicators (BT225) are single-use Self-Contained Biological Indicators (SCBIs) that are formed by a carrier with Geobacillus stearothermophilus ATCC 7953 spores and an ampoule containing a bacteriological growth medium. Both, the media ampoule and the carrier, are contained in a polypropylene tube enclosed with a black cap with holes and a barrier permeable to steam.
Each SCBI has a label located on the outside of the tube. This label contains information regarding the expiration date and the lot of the SCBI, as well as a chemical process indicator that turns from pink to brown to indicate that the SCBI has been exposed to steam.
Terragene® Bionova® Photon Auto-reader Incubator (BPH) has been designed for the incubation at 60 ℃ and automatic readout of the Bionova® Photon line of Self-contained Biological Indicators (SCBIs) appropriate for monitoring steam sterilization cycles. It allows an instant readout (7-second) of the BT225 SCBI using fluorescence technology and 48-hour incubation for visual color change confirmation.
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K Number
K232103Device Name
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Manufacturer
Terragene SA
Date Cleared
2024-04-05
(266 days)
Product Code
QKM, JOJ, OKM
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Terragene SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Terragene® Chemdye® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® NX Sterilization System (Standard and Advanced cycles).
- · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
- · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
- · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
The chemical indicator changes from purple to green to indicate that the conditions of the cycle have been met.
Terragene® Chemical Process Indicator (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® NX Sterilization System (Standard and Advanced cycles).
- · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
- · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
- · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer (Cycle 1).
The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene® Cintape® Chemical Process Indicator Tape (CT40) is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
- · Sterrad® 100S Sterilization System.
- · Sterrad® NX Sterilization System (Standard and Advance cycles).
- · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
- · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
- · Sterrad® 100NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
- · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
- · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
- · Sterizone® VP4 Sterilizer (Cycle 1).
The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
Device Description
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K Number
K221641Device Name
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
Manufacturer
Terragene SA
Date Cleared
2023-02-28
(267 days)
Product Code
FRC, JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Terragene SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Terragene® Bionova® Hyper Biological Indicator (BT98) is a self-contained biological indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of Plasma or Vaporized Hydrogen Peroxide sterilization processes in the following systems:
-Sterrad® 100S Sterilization System.
-Sterrad® NX Sterilization System (Standard and Advanced Cycles).
-Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced Cycles).
-Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo Cycles).
-Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo Cycles).
-V-Pro@ S2 Low Temperature Sterilization System (Fast, Non Lumen and Flexible Cycles).
-V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen. Lumen and Flexible Cycles).
Terragene® Bionova® BT98 has Hyper Rapid readout at 5 minutes at 60 ℃.
Terragene® Bionova® Hyper Auto-reader Incubator (BHY) incubates at 60 °C and reads the Terragene® Bionova® Hyper SCBIs at the times prescribed in the User Manual.
Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) incubates at 60 °C and reads the Bionova® SCBIs at the times prescribed in the User Manual.
Device Description
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K Number
K200272Device Name
Terragene Chemdye
Manufacturer
Terragene SA
Date Cleared
2020-06-30
(147 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Terragene SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Terragene Chemdye® Bowie-Dick Test Pack (BD125X/1), Bowie-Dick Test Card (BD8948X/1) and Bowie-Dick Test Sheet (BDA4/1) are designed for testing air removal efficiency for cycles of 132ºC for 3.5 minutes in dynamicair-removal steam sterilizers.
Device Description
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K Number
K191021Device Name
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
Manufacturer
Terragene SA
Date Cleared
2019-09-13
(149 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Terragene SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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K Number
K163646Device Name
Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator
Manufacturer
Terragene SA
Date Cleared
2017-11-02
(314 days)
Product Code
FRC
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Terragene SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10f Geobacillus stearothermophilus bacterial spores and is intended for monitoring the effication processes. Oneach Terragene Bionova® SCB is a chemical process indicator that changes color from pink to brown when exposed to steam.
Terragene Bionova® PCD (PCD220-C. PCD222-C. PCD222-C. PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.
Terragene Bionova® IC10/20FR Reader Incubates at 60 ℃ and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT221, BT222), and 3 hours (BT220)
Device Description
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