510(k) K251559
K251559 is an FDA 510(k) premarket notification submitted by True Indicating, LLC for the device "InstaTRU Instant Biological Indicator for Steam (IBI-05)". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code QVB (Biological Sterilization Indicator With Indirect Growth Detection), a Class II device regulated under 21 CFR 880.2806. True Indicating, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2026
- Date Received
- May 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biological Sterilization Indicator With Indirect Growth Detection
- Device Class
- Class II
- Regulation Number
- 880.2806
- Review Panel
- HO
- Submission Type
A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.