# K250250: ADVIA Centaur Anti-Thyroid Peroxidase II

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 17, 2025 after 262 days
- Product code: JZO (System, Test, Thyroid 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: 2 generations back to K020348 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052407: Architect Anti-Tpo Immunoassay, Calibrators & Controls, Fisher Diagnostics (2006) Summary page 6.

## Indications for use
The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and/or Graves' disease.

Source page: https://510kreport.com/device/K250250
Methodology: https://510kreport.com/methodology