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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 / March 2026 / K260787

510(k) cleared

FebriDx Bacterial/Non-bacterial Assay

Lumos Diagnostics, Inc. · Mar 24, 2026 · K260787

FDA cleared the FebriDx Bacterial/Non-bacterial Assay from Lumos Diagnostics, Inc. on Mar 24, 2026 under K260787, a dual track 510(k). The device falls under product code QXA, Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection, regulated at 21 CFR 866.3230 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Mar 10, 2026. The decision came 14 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Lumos Diagnostics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260787?

K260787 is the FDA 510(k) for FebriDx Bacterial/Non-bacterial Assay, submitted by Lumos Diagnostics, Inc.. FDA's decision date was Mar 24, 2026, under product code QXA (Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection).

Who makes the FebriDx Bacterial/Non-bacterial Assay?

Lumos Diagnostics, Inc., based in Carlsbad, CA, is the applicant of record for K260787.

How long did the K260787 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on Mar 24, 2026, 14 days later.

← All decisions in March 2026