Siemens Healthcare Diagnostics, Inc. · Class II · Cleared Oct 17, 2025
| K-number | K250250 |
| Device name | ADVIA Centaur Anti-Thyroid Peroxidase II |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | JZO |
| Device class | Class II |
| Decision date | Oct 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.5870 |
The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) is an in vitro diagnostic assay that quantitatively measures autoantibodies against thyroid peroxidase in human serum and plasma using the ADVIA Centaur XP system. It is used as an aid in diagnosing autoimmune thyroiditis and Graves' disease, in conjunction with clinical assessment.
The candidate device uses a fully automated one-step competitive chemiluminescent immunoassay with an assay range of 4.6–400.0 IU/mL, compared to the predicate's 0.5–1000.0 IU/mL range. Both measure quantitatively using chemiluminescent technology, accept the same sample types (serum and plasma), and are standardized to NIBSC 66/387. The candidate uses 2 calibration levels versus the predicate's 6 levels, and has a clinical cut-off of 10.4 IU/mL versus 5.6 IU/mL.
Performance was characterized using CLSI Document EP17-A2 (detection capability), EP05-A3 (precision and reproducibility), EP06-ed2 (linearity), EP09c-Ed3 (specimen equivalence), EP07-Ed3 (interference and cross-reactivity), EP28-A3c (reference intervals), and EP12-A2 (clinical performance).
The ADVIA Centaur aTPOII is substantially equivalent to the Architect Anti-TPO because both measure the same analyte (anti-TPO antibodies) using chemiluminescent technology for the same intended diagnostic purpose, accept identical sample types, and demonstrate comparable clinical sensitivity (71.5%) and specificity (81.7%) with strong agreement to a predicate assay (87.7% PPA, 98.1% NPA). Differences in assay range and calibration levels do not affect clinical equivalence.
View the full FDA submission: accessdata.fda.gov