K250816 is an FDA 510(k) clearance for the ADVIA Centaur Anti-Thyroglobulin II (aTgII). This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K250816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JNL — Immunochemical, Thyroglobulin Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |