510(k) · Cleared
ClearedElecsys Phospho-Tau (181P) 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 Oct 8, 2025 as substantially equivalent to K221842 (Roche Diagnostics, 2022) after a 90-day review. Its family tree reaches back 2 generations to 2022.
- Decided
- Oct 8, 2025
- 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 K261686 Elecsys Phospho-Tau (217P) Plasmascore 12.2 · 2 generations · 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 |
|---|---|---|---|
| * | K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFSummary page 5…Elecsys β-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF Submission where de novo was granted K221842 Product Code QSE 21 CFR 807.92(a)(4)… | 2022 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K221842.
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. 2025, 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?
Elecsys Phospho-Tau (181P) Plasma is an in vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein in human plasma on cobas e immunoassay analyzers. The Elecsys Phospho-Tau (181P) Plasma assay result is intended to be used as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms…
Read the full statement (218 words)
Elecsys Phospho-Tau (181P) Plasma is an in vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein in human plasma on cobas e immunoassay analyzers.
The Elecsys Phospho-Tau (181P) Plasma assay result is intended to be used as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms, or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.
A negative test result is consistent with a negative amyloid positron emission tomography (PET) scan result and reduced likelihood that a patient's cognitive impairment is due to amyloid pathology. These patients should be investigated for other causes of cognitive decline.
A positive test result may not be consistent with a positive amyloid PET scan result. Patients with an initial positive result should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.
Limitations of use
The Elecsys Phospho-Tau (181P) Plasma assay is not recommended for patients with signs, symptoms, or complaints of cognitive decline, who are already referred to the specialist.
The performance of Elecsys Phospho-Tau (181P) Plasma has not been established for:
▪ Predicting development of dementia or other neurologic conditions.
▪ Monitoring responses to therapies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252163: Elecsys Phospho-Tau (181P) Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252163
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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