Cleared Traditional

ADVIA Centaur Anti-Thyroid Peroxidase II

K250250 · Siemens Healthcare Diagnostics, Inc. · Immunology
Oct 2025
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K250250 is an FDA 510(k) clearance for the ADVIA Centaur Anti-Thyroid Peroxidase II, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on October 17, 2025, 262 days after receiving the submission on January 28, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K250250 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2025
Decision Date October 17, 2025
Days to Decision 262 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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