510(k) · Cleared
ClearedElecsys FT4 II Assay, Elecsys FT4 II Calset
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 Jan 27, 2014 as substantially equivalent to K961489 (Boehringer Mannheim Corp., 1996) after a 271-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Jan 27, 2014
- Review
- 271 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900883 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK900883 Enzymun Test (R) FT4 (Free Thyroxine)Boehringer Mannheim Corp. · 1990
- 1 generation backK961489 Elecsys FT4 AssayBoehringer Mannheim Corp. · 1996
- This deviceK131244 Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK220456 Elecsys FT4 IVRoche Diagnostics · 2023
- Descendant · cites it directly · 0 of its ownK181233 Elecsys FT4 IIIRoche Diagnostics · 2018
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 |
|---|---|---|---|---|---|
| −2 | K900883 | Enzymun Test (R) FT4 (Free Thyroxine) | Boehringer Mannheim Corp. | 1990 | — |
| −1 | K961489 | Elecsys FT4 Assay | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K131244 | Elecsys FT4 II Assay, Elecsys FT4 II Calset | Roche Diagnostics | 2014 | — |
| +1 | K220456 | Elecsys FT4 IV | Roche Diagnostics | 2023 | — |
| +1 | K181233 | Elecsys FT4 III | Roche Diagnostics | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K961489 | Elecsys FT4 AssaySummary page 1…s: (1) CEC, 21 CFR 862.1695 (2) JIT, 21 CFR 862.1150 Predicate Devices: (1) Eleesys FT4 Assay (K96 1489) CEC, 21 CER 862.1695 (2) Elecsys FT4 C… | 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?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 17.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220456 (Roche Diagnostics, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K961489.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Elecsys FT4 II Assay is 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 diseases.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys FT4 II CalSet is used for calibrating the quantitative Elecsys FT4 II assay on the Elecsys and cobas e immunoassay analyzers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131244: Elecsys FT4 II Assay, Elecsys FT4 II Calset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131244
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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