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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 / July 2026 / K254295

510(k) cleared

Sofia Lyme FIA; Sofia 2 Campylobacter FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · Jul 10, 2026 · K254295

FDA cleared the Sofia Lyme FIA; Sofia 2 Campylobacter FIA from Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) on Jul 10, 2026 under K254295, a traditional 510(k). The device falls under product code LSR, Reagent, Borrelia Serological Reagent, regulated at 21 CFR 866.3830 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 31, 2025. The decision came 191 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) has one other decision in the tracker over the last 12 months: K252393 (VITROS Immunodiagnostic Products hs Troponin I Reagent Pack).

Questions & Answers

What did FDA clear under K254295?

K254295 is the FDA 510(k) for Sofia Lyme FIA; Sofia 2 Campylobacter FIA, submitted by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). FDA's decision date was Jul 10, 2026, under product code LSR (Reagent, Borrelia Serological Reagent).

Who makes the Sofia Lyme FIA; Sofia 2 Campylobacter FIA?

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho), based in San Diego, CA, is the applicant of record for K254295.

How long did the K254295 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Jul 10, 2026, 191 days later.

← All decisions in July 2026

Sources