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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 / February 2026 / K253539

510(k) cleared

Alere NT-proBNP for Alinity i

Axis-Shield Diagnostics, Ltd. · Feb 18, 2026 · K253539

FDA cleared the Alere NT-proBNP for Alinity i from Axis-Shield Diagnostics, Ltd. on Feb 18, 2026 under K253539, a traditional 510(k). The device falls under product code NBC, Test, Natriuretic Peptide, regulated at 21 CFR 862.1117 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Nov 13, 2025. The decision came 97 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Axis-Shield Diagnostics, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253539?

K253539 is the FDA 510(k) for Alere NT-proBNP for Alinity i, submitted by Axis-Shield Diagnostics, Ltd.. FDA's decision date was Feb 18, 2026, under product code NBC (Test, Natriuretic Peptide).

Who makes the Alere NT-proBNP for Alinity i?

Axis-Shield Diagnostics, Ltd., based in Dundee, is the applicant of record for K253539.

How long did the K253539 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Feb 18, 2026, 97 days later.

← All decisions in February 2026