510(k) · Cleared
ClearedADVIA Centaur Anti-Thyroglobulin II (aTgII)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JNL Immunochemical, Thyroglobulin Autoantibody
Cleared on Dec 4, 2025 as substantially equivalent to K112933 (Beckman Coulter, Inc., 2011) after a 261-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Dec 4, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- JNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K012208 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK012208 Access Thyroglobulin Antibody and Calibrators on the Access…Beckman Coulter, Inc. · 2001 · Recalled
- 2 generations backK062516 Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and…Beckman Coulter, Inc. · 2006 · Recalled
- 1 generation backK112933 Access Thyroglobulin AnitbodyBeckman Coulter, Inc. · 2011 · Recalled
- This deviceK250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay… | Beckman Coulter, Inc. | 2001 | 1 |
| −2 | K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920… | Beckman Coulter, Inc. | 2006 | 2 |
| −1 | K112933 | Access Thyroglobulin Anitbody | Beckman Coulter, Inc. | 2011 | 2 |
| 0 (this device) | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | 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 JNL? 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 JNL device
- #1 K240996 Access Thyroglobulin Antibody IIscore 8.5 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K112933 | Access Thyroglobulin AnitbodySummary page 5…866.5870 4. Predicate Device Information Name of Device Name: Beckman Coulter Access Thyroglobulin Antibody II (TgAbII) assay 510(k) Number: K112933 5. Intended Use / Indications for Use The ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay is for in vitro diagnos… | 2011 |
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 24 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K112933.
How does its category compare?
All JNL devicesJNL Immunochemical, Thyroglobulin Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JNL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JNL
Too few JNL 510(k)s in any year since 2007 to give a median.
Recalls per year · JNL
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JNL
1in 2025
MAUDE reports naming product code JNL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250816: ADVIA Centaur Anti-Thyroglobulin II (aTgII).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250816
Report an extraction error
Are you the manufacturer?
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