510(k) · Cleared
ClearedAcs 180 and Advia Centaur FT4 Immunoassays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CEC Radioimmunoassay, Free Thyroxine
Cleared on Aug 8, 2008 as substantially equivalent to K961510 (Ciba Corning Diagnostics Corp., 1996) after a 198-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Aug 8, 2008
- Review
- 198 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961510 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961510 Acs FRT4 ImmunoassayCiba Corning Diagnostics Corp. · 1996 · Recalled
- This deviceK080167 Acs 180 and Advia Centaur FT4 ImmunoassaysSiemens Healthcare Diagnostics · 2008
- Descendant · cites it directly · 0 of its ownK182423 Maglumi 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK132249 Advia Centaur FT4, Advia Centaur T4Siemens Healthcare Diagnostics, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961510 | Acs FRT4 Immunoassay | Ciba Corning Diagnostics Corp. | 1996 | 4 |
| 0 (this device) | K080167 | Acs 180 and Advia Centaur FT4 Immunoassays | Siemens Healthcare Diagnostics | 2008 | — |
| +1 | K182423 | Maglumi 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018 | — |
| +1 | K132249 | Advia Centaur FT4, Advia Centaur T4 | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K961510 | Acs FRT4 ImmunoassaySummary page 1…Predicate Device Device Name ACS:180 Free T4 Assay Common name ACS FrT4 510(k) Number k961510 Manufacturer Siemens Healthcare Diagnostics (formerly Siemens Medical Solutions Diag… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The ADVIA Centaur FT4 Immunoassay is 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 diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080167: Acs 180 and Advia Centaur FT4 Immunoassays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080167
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