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510(k) Data Aggregation
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?
Product Code :
QVB
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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