WHERE ARE YOU?

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

THE TAPE

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 / December 2025 / K253839

510(k) cleared

Elecsys Anti-SARS-CoV-2

Roche Diagnostics · Dec 17, 2025 · K253839

FDA cleared the Elecsys Anti-SARS-CoV-2 from Roche Diagnostics on Dec 17, 2025 under K253839, a special 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 Dec 1, 2025. The decision came 16 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 K253839?

K253839 is the FDA 510(k) for Elecsys Anti-SARS-CoV-2, submitted by Roche Diagnostics. FDA's decision date was Dec 17, 2025, under product code QVP (Sars-Cov-2 Serology Test).

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

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K253839.

How long did the K253839 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Dec 17, 2025, 16 days later.

← All decisions in December 2025