FDA Product Code QVB: Biological Sterilization Indicator With Indirect Growth Detection
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.
Leading manufacturers include Terragene S.A. and Steritec Products.
3
Total
2
Cleared
469d
Avg days
2024
Since
Growing category -
3 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Biological Sterilization Indicator With Indirect Growth Detection Devices (Product Code QVB)
3 devices
Cleared
Apr 22, 2026
Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)
Steritec Products
General Hospital
272d
Not Cleared
Jul 12, 2024
Terragene Bionova Photon Biological Indicator (BT225)
Terragene S.A.
General Hospital
742d
About Product Code QVB - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QVB since 2024, with 2 receiving FDA clearance (average review time: 469 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.