WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / DEN260027

510(k) cleared

Elecsys HBsAg II quant II RxDx

Roche Diagnostics · Oct 20, 2026 · DEN260027

FDA cleared the Elecsys HBsAg II quant II RxDx from Roche Diagnostics on Oct 20, 2026 under DEN260027, a direct 510(k). The review panel was Unknown.

FDA logged the submission as received on Jun 2, 2026. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roche Diagnostics has 8 other decisions in the tracker over the last 12 months: K260221 (Elecsys EBV EBNA IgG), K260232 (Elecsys EBV VCA IgG), K260233 (Elecsys EBV IgM), K261686 (Elecsys Phospho-Tau (217P) Plasma).

Questions & Answers

What did FDA clear under DEN260027?

DEN260027 is the FDA 510(k) for Elecsys HBsAg II quant II RxDx, submitted by Roche Diagnostics. FDA's decision date was Oct 20, 2026, under product code SJM.

Who makes the Elecsys HBsAg II quant II RxDx?

Roche Diagnostics, based in Indianapolis, IL, is the applicant of record for DEN260027.

How long did the DEN260027 review take?

FDA received the submission on Jun 2, 2026 and issued its decision on Oct 20, 2026, 140 days later.

← All decisions in October 2026