Cleared Traditional

ADVIA Centaur Anti-Thyroglobulin II (aTgII)

K250816 · Siemens Healthcare Diagnostics, Inc. · Immunology
Dec 2025
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K250816 is an FDA 510(k) clearance for the ADVIA Centaur Anti-Thyroglobulin II (aTgII), a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on December 4, 2025, 261 days after receiving the submission on March 18, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K250816 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2025
Decision Date December 04, 2025
Days to Decision 261 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JNL — Immunochemical, Thyroglobulin Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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