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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 / K260048

510(k) cleared

Elecsys Anti-HAV IgM

Roche Diagnostics · Apr 7, 2026 · K260048

FDA cleared the Elecsys Anti-HAV IgM from Roche Diagnostics on Apr 7, 2026 under K260048, a traditional 510(k). The device falls under product code LOL, Hepatitis A Test (Antibody And Igm Antibody), regulated at 21 CFR 866.3310 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), K260046 (Elecsys Anti-HBc II).

Questions & Answers

What did FDA clear under K260048?

K260048 is the FDA 510(k) for Elecsys Anti-HAV IgM, submitted by Roche Diagnostics. FDA's decision date was Apr 7, 2026, under product code LOL (Hepatitis A Test (Antibody And Igm Antibody)).

Who makes the Elecsys Anti-HAV IgM?

Roche Diagnostics, based in Indianapolis, IL, is the applicant of record for K260048.

How long did the K260048 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