510(k) · Cleared
ClearedAdvia Centaur FT4, Advia Centaur T4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CEC Radioimmunoassay, Free Thyroxine
Cleared on Sep 13, 2013 as substantially equivalent to K080167 (Siemens Healthcare Diagnostics, 2008) after a 56-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Sep 13, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961510 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK961510 Acs FRT4 ImmunoassayCiba Corning Diagnostics Corp. · 1996 · Recalled
- 1 generation backK080167 Acs 180 and Advia Centaur FT4 ImmunoassaysSiemens Healthcare Diagnostics · 2008
- This deviceK132249 Advia Centaur FT4, Advia Centaur T4Siemens Healthcare Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
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 CEC? 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 CEC device
- #1 K240273 Access Free T4score 7.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080167 | Acs 180 and Advia Centaur FT4 ImmunoassaysSummary page 1…FT4 AD VIA Centaur5 T4 Subject Device Same (As above) Same (As above) Original 510(k) K080167 K<905532 Siemens Healthcare Diagnostics Inc., Tarrytown, NY… | 2008 |
| Kept off the family tree | K090532 | FDA’s K090532 is T.E.a.R. TECH3 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
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 17 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K080167.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CEC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEC
238in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEC
213in 2025
MAUDE reports naming product code CEC, 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 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 3 | 7 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 3 | 238 | 0 | 40 |
| 2015 | 1 | — | 0 | 166 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 1 | — | 0 | 196 |
| 2018 | 2 | — | 1 | 199 |
| 2019 | 0 | — | 0 | 167 |
| 2020 | 0 | — | 0 | 106 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 81 |
| 2023 | 1 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 276 |
| 2025 | 0 | — | 0 | 213 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA), using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease.
For in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroxine are used in the diagnosis and treatment of thyroid disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132249: Advia Centaur FT4, Advia Centaur T4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132249
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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