510(k) · Cleared
ClearedElecsys FT4 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CEC Radioimmunoassay, Free Thyroxine
Cleared on Jun 11, 1996 as substantially equivalent to K900883 (Boehringer Mannheim Corp., 1990) after a 54-day review. Its family tree reaches back 1 generation to 1990. 5 later devices descend from it.
- Decided
- Jun 11, 1996
- Review
- 54 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900883 (1990). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK900883 Enzymun Test (R) FT4 (Free Thyroxine)Boehringer Mannheim Corp. · 1990
- This deviceK961489 Elecsys FT4 AssayBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 2 of its ownK131244 Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics · 2014
- Descendant · 2 generations on · 0 of its ownK220456 Elecsys FT4 IVRoche Diagnostics · 2023
- Descendant · 2 generations on · 0 of its ownK181233 Elecsys FT4 IIIRoche Diagnostics · 2018
- Descendant · cites it directly · 0 of its ownK132058 Vidas FT4Biomerieux S.A. · 2015
- Descendant · cites it directly · 0 of its ownK121951 Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2…DiaSorin, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K131244Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics · 2014 · cites it directly2descendants
- K220456Elecsys FT4 IVRoche Diagnostics · 2023 · 2 generations on0descendants
- K181233Elecsys FT4 IIIRoche Diagnostics · 2018 · 2 generations on0descendants
- K132058Vidas FT4Biomerieux S.A. · 2015 · cites it directly0descendants
- K121951Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3DiaSorin, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900883 | Enzymun Test (R) FT4 (Free Thyroxine) | Boehringer Mannheim Corp. | 1990 | — |
| 0 (this device) | K961489 | Elecsys FT4 Assay | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K131244 | Elecsys FT4 II Assay, Elecsys FT4 II Calset | Roche Diagnostics | 2014 | — |
| +2 | K220456 | Elecsys FT4 IV | Roche Diagnostics | 2023 | — |
| +2 | K181233 | Elecsys FT4 III | Roche Diagnostics | 2018 | — |
| +1 | K132058 | Vidas FT4 | Biomerieux S.A. | 2015 | — |
| +1 | K121951 | Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison… | DiaSorin, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K900883 | Enzymun Test (R) FT4 (Free Thyroxine)Summary page 1…e assay for the determination of free thyroxine (FT4). Classification name: Radioimmunoassay, Free Thyroxine We claim substantial equivalence to the Enzymun-Test® FT4 (K900883) The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37° C). *Ist incubation (9… | 1990 |
What descends from it? (5)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K131244 (Roche Diagnostics, 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Immunoassay for the in vitro quantitative determination of free thyroxine in human serum and plasma.
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/K961489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961489: Elecsys FT4 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961489
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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