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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K260046

510(k) cleared

Elecsys Anti-HBc II

Roche Diagnostics · Apr 7, 2026 · K260046

FDA cleared the Elecsys Anti-HBc II from Roche Diagnostics on Apr 7, 2026 under K260046, a traditional 510(k). The device falls under product code SEI, Qualitative And Quantitative Hepatitis B Virus Antibody Assays, regulated at 21 CFR 866.3173 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 7, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Roche Diagnostics has 8 other decisions in the tracker over the last 12 months: K252323 (cobas pulse blood glucose monitoring system), K252431 (Elecsys Calcitonin), K252280 (Elecsys Anti-SARS-CoV-2 S), K260048 (Elecsys Anti-HAV IgM).

Questions & Answers

What did FDA clear under K260046?

K260046 is the FDA 510(k) for Elecsys Anti-HBc II, submitted by Roche Diagnostics. FDA's decision date was Apr 7, 2026, under product code SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays).

Who makes the Elecsys Anti-HBc II?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K260046.

How long did the K260046 review take?

FDA received the submission on Jan 7, 2026 and issued its decision on Apr 7, 2026, 90 days later.

← All decisions in April 2026