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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 / December 2025 / K250816

510(k) cleared

ADVIA Centaur Anti-Thyroglobulin II (aTgII)

Siemens Healthcare Diagnostics, Inc. · Dec 4, 2025 · K250816

FDA cleared the ADVIA Centaur Anti-Thyroglobulin II (aTgII) from Siemens Healthcare Diagnostics, Inc. on Dec 4, 2025 under K250816, a traditional 510(k). The device falls under product code JNL, Immunochemical, Thyroglobulin Autoantibody, regulated at 21 CFR 866.5870 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Mar 18, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Healthcare Diagnostics, Inc. has 8 other decisions in the tracker over the last 12 months: K253985 (INNOVANCE® D-Dimer 2.0 (SMN 10873803)), K253528 (Atellica IM CA 19-9 II), K261364 (Atellica CH Acetaminophen 2 (ACTM)), K253264 (myAblation Guide (VC10A)).

Questions & Answers

What did FDA clear under K250816?

K250816 is the FDA 510(k) for ADVIA Centaur Anti-Thyroglobulin II (aTgII), submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was Dec 4, 2025, under product code JNL (Immunochemical, Thyroglobulin Autoantibody).

Who makes the ADVIA Centaur Anti-Thyroglobulin II (aTgII)?

Siemens Healthcare Diagnostics, Inc., based in Tarrytown, NJ, is the applicant of record for K250816.

How long did the K250816 review take?

FDA received the submission on Mar 18, 2025 and issued its decision on Dec 4, 2025, 261 days later.

← All decisions in December 2025