510(k) · Cleared
ClearedElecsys T4 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CDX Radioimmunoassay, Total Thyroxine
Cleared on Jun 13, 1996 as substantially equivalent to K901346 (Boehringer Mannheim Corp., 1990) after a 56-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 13, 1996
- Review
- 56 days
- Class
- Class II
- Product code
- CDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901346 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK901346 ES 300 Immunoassay SystemBoehringer Mannheim Corp. · 1990
- This deviceK961490 Elecsys T4 AssayBoehringer Mannheim Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901346 | ES 300 Immunoassay System | Boehringer Mannheim Corp. | 1990 | — |
| 0 (this device) | K961490 | Elecsys T4 Assay | Boehringer Mannheim Corp. | 1996 | — |
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 CDX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K901346 | ES 300 Immunoassay SystemSummary page 1…e assay for the determination of total thyroxine (T4). Classification name: Radioimmunoaésay, Total Thyroxine We claim substantial equivalence to the Enzymun T4 Assay( K901346). The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37° C). *1st incubation (… | 1990 |
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?
- Its one ancestor has no recall.
How does its category compare?
All CDX devicesCDX Radioimmunoassay, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDX
FDA has decided no CDX device since 2007.
Median 510(k) review, days · CDX
Too few CDX 510(k)s in any year since 2007 to give a median.
Recalls per year · CDX
No recall names CDX since 2007.
Adverse event reports per year · CDX
8in 2025
MAUDE reports naming product code CDX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of total 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/K961490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961490: Elecsys T4 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961490
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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