DeviceClearance

Product code QVB— General Hospital

InstaTRU Instant Biological Indicator for Steam (IBI-05)

Classification name
Biological Sterilization Indicator With Indirect Growth Detection
Device class
Class 2
Regulation
21 CFR 880.2806
Advisory panel
General Hospital
Total cleared
3
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QVB under 21 CFR 880.2806, via openFDA

Market context for product code QVB

FDA has cleared 3 devices under product code QVB between 2024 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QVB

Recent clearances under product code QVB

Data sourced from openFDA. This site is unofficial and independent of the FDA.