510(k) · Cleared
ClearedElecsys Phospho-Tau (217P) Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · SET Immunoassay Blood Test For Amyloid Pathology Assessment
Cleared on Aug 19, 2026 as substantially equivalent to K242706 (Fujirebio Diagnostics,Inc., 2025) after a 90-day review. Its family tree reaches back 2 generations to 2022.
- Decided
- Aug 19, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- SET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200072 (2022). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 SET? 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 SET device
- #1 K253240 PrecivityAD2 Testscore 11.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioSummary page 5…oduct Codes SET Predicate Devices Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio Submission Where 510(k) Clearance was K242706 Granted Page 1 === Page 6… | 2025 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All SET devicesSET Immunoassay Blood Test For Amyloid Pathology Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SET
Too few SET 510(k)s in any year since 2007 to give a median.
Recalls per year · SET
No recall names SET since 2007.
Adverse event reports per year · SET
No MAUDE report names SET since 2007.
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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Elecsys Phospho-Tau (217P) Plasma assay is an in vitro immunoassay for the determination of the phospho-tau (217P) (pTau217) protein in human plasma from individuals aged 55 years and older.
The assay is intended for use as an aid in identifying patients with amyloid pathology presenting with signs, symptoms, or complaints of cognitive decline associated with Alzheimer's disease. The Elecsys Phospho-Tau (217P) Plasma assay result must be used in the diagnostic pathway in conjunction with other clinical information.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on 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/K261686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261686: Elecsys Phospho-Tau (217P) Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261686
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026