Not Cleared Direct

DEN220042 - Terragene Bionova Photon Biological Indicator (BT225) (FDA 510(k) Clearance)

Also includes:
Terragene Bionova Photon Auto-Reader Incubator (BPH)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220042 · Terragene S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
742d
Days
Class 2
Risk

DEN220042 is an FDA 510(k) submission (not cleared) for the Terragene Bionova Photon Biological Indicator (BT225). Classified as Biological Sterilization Indicator With Indirect Growth Detection (product code QVB), Class II - Special Controls.

Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Not Cleared (DENG) decision on July 12, 2024 after a review of 742 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2806 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 742 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Terragene S.A. devices

Submission Details

510(k) Number DEN220042 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 01, 2022
Decision Date July 12, 2024
Days to Decision 742 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
614d slower than avg
Panel avg: 128d · This submission: 742d
Pathway characteristics

Device Classification

Product Code QVB Biological Sterilization Indicator With Indirect Growth Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2806
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.