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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 / K252280

510(k) cleared

Elecsys Anti-SARS-CoV-2 S

Roche Diagnostics · Apr 13, 2026 · K252280

FDA cleared the Elecsys Anti-SARS-CoV-2 S from Roche Diagnostics on Apr 13, 2026 under K252280, a traditional 510(k). The device falls under product code QVP, Sars-Cov-2 Serology Test, regulated at 21 CFR 866.3983 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 22, 2025. The decision came 265 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: K252323 (cobas pulse blood glucose monitoring system), K252431 (Elecsys Calcitonin), K260046 (Elecsys Anti-HBc II), K260048 (Elecsys Anti-HAV IgM).

Questions & Answers

What did FDA clear under K252280?

K252280 is the FDA 510(k) for Elecsys Anti-SARS-CoV-2 S, submitted by Roche Diagnostics. FDA's decision date was Apr 13, 2026, under product code QVP (Sars-Cov-2 Serology Test).

Who makes the Elecsys Anti-SARS-CoV-2 S?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K252280.

How long did the K252280 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Apr 13, 2026, 265 days later.

← All decisions in April 2026