# K250816: ADVIA Centaur Anti-Thyroglobulin II (aTgII)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 4, 2025 after 261 days
- Product code: JNL (Immunochemical, Thyroglobulin Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K012208 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112933: Access Thyroglobulin Anitbody, Beckman Coulter, Inc. (2011) Summary page 5.

## Indications for use
The ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroglobulin in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. Anti-thyroglobulin (aTg) measurements are used, in conjunction with clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and Graves’ disease.

Source page: https://510kreport.com/device/K250816
Methodology: https://510kreport.com/methodology