Not Cleared Direct

DEN260027 - Elecsys HBsAg II quant II RxDx

DEN260027 · Roche Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
140d
Days
-
Risk

DEN260027 is an FDA 510(k) submission (not cleared) for the Elecsys HBsAg II quant II RxDx.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Not Cleared (DENG) decision on October 20, 2026 after a review of 140 days.

This device falls under the Microbiology FDA review panel. 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

FDA 510(k) Submission Details - DEN260027

510(k) Number DEN260027 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 02, 2026
Decision Date October 20, 2026
Days to Decision 140 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics

SJM Device Classification - Class ,

Product Code SJM
Device Class -
DEN260027 · Elecsys HBsAg II quant II RxDx
Download PDF Roche Diagnostics