510(k) · Cleared
ClearedElecsys FT4 III
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CEC Radioimmunoassay, Free Thyroxine
Cleared on Sep 18, 2018 as substantially equivalent to K131244 (Roche Diagnostics, 2014) after a 132-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Sep 18, 2018
- Review
- 132 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900883 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK900883 Enzymun Test (R) FT4 (Free Thyroxine)Boehringer Mannheim Corp. · 1990
- 2 generations backK961489 Elecsys FT4 AssayBoehringer Mannheim Corp. · 1996
- 1 generation backK131244 Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics · 2014
- This deviceK181233 Elecsys FT4 IIIRoche Diagnostics · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900883 | Enzymun Test (R) FT4 (Free Thyroxine) | Boehringer Mannheim Corp. | 1990 | — |
| −2 | K961489 | Elecsys FT4 Assay | Boehringer Mannheim Corp. | 1996 | — |
| −1 | K131244 | Elecsys FT4 II Assay, Elecsys FT4 II Calset | Roche Diagnostics | 2014 | — |
| 0 (this device) | K181233 | Elecsys FT4 III | Roche Diagnostics | 2018 | — |
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 |
|---|---|---|---|
| * | K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetSummary page 5…unoassay, Free thyroxine test system Classification Name Product Codes, CEC, 21CFR862.1695 Regulation Numbers Predicate Devices Elecsys FT4 II (K131244) For the Elecsys FT4 III, the establishment registration number for Roche… | 2014 |
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 28 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K131244.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Assay for the in vitro quantitative determination of free thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 411 immunoassay analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181233: Elecsys FT4 III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181233
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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