510(k) · Cleared
ClearedADVIA Centaur Anti-Thyroid Peroxidase II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JZO System, Test, Thyroid Autoantibody
Cleared on Oct 17, 2025 as substantially equivalent to K052407 (Fisher Diagnostics, 2006) after a 262-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Oct 17, 2025
- Review
- 262 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020348 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK020348 Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising…Axis-Shield Diagnostics, Ltd. · 2002
- 1 generation backK052407 Architect Anti-Tpo Immunoassay, Calibrators & ControlsFisher Diagnostics · 2006 · Recalled
- This deviceK250250 ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020348 | Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising… | Axis-Shield Diagnostics, Ltd. | 2002 | — |
| −1 | K052407 | Architect Anti-Tpo Immunoassay, Calibrators & Controls | Fisher Diagnostics | 2006 | 2 |
| 0 (this device) | K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JZO device
- #1 K213517 Access Thyroglobulin Antibody IIscore 9.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052407 | Architect Anti-Tpo Immunoassay, Calibrators & ControlsSummary page 6…ens Healthcare Diagnostics 510(k) Summary Regulation 21 CFR 866.5870 Number PREDICATE DEVICE Name of Device: Architect Anti-TPO 510(k): K052407 DEVICE DESCRIPTION The following devices are included in the ADVIA Centaur® Anti-Thyroid Peroxidase II (aTPOII): Material… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 19.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JZO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JZO
Too few JZO 510(k)s in any year since 2007 to give a median.
Recalls per year · JZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JZO
44in 2025
MAUDE reports naming product code JZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 29 |
| 2025 | 1 | — | 1 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250250: ADVIA Centaur Anti-Thyroid Peroxidase II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250250
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026