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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 / October 2025 / K250666

510(k) cleared

Alegria Flash CTD Screen

Zeus Scientific · Oct 22, 2025 · K250666

FDA cleared the Alegria Flash CTD Screen from Zeus Scientific on Oct 22, 2025 under K250666, a traditional 510(k). The device falls under product code LLL, Extractable Antinuclear Antibody, Antigen And Control, regulated at 21 CFR 866.5100 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Mar 5, 2025. The decision came 231 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zeus Scientific has 2 other decisions in the tracker over the last 12 months: K250814 (Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB), K250408 (Alegria Flash ENA Screen).

Questions & Answers

What did FDA clear under K250666?

K250666 is the FDA 510(k) for Alegria Flash CTD Screen, submitted by Zeus Scientific. FDA's decision date was Oct 22, 2025, under product code LLL (Extractable Antinuclear Antibody, Antigen And Control).

Who makes the Alegria Flash CTD Screen?

Zeus Scientific, based in Branchburg, NJ, is the applicant of record for K250666.

How long did the K250666 review take?

FDA received the submission on Mar 5, 2025 and issued its decision on Oct 22, 2025, 231 days later.

← All decisions in October 2025

Sources