WHERE ARE YOU?

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

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: 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 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