# K261686: Elecsys Phospho-Tau (217P) Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 19, 2026 after 90 days
- Product code: SET (Immunoassay Blood Test For Amyloid Pathology Assessment)
- Device class: 2
- Regulation: 21 CFR 866.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200072 (2022). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242706: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, Fujirebio Diagnostics,Inc. (2025) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K261686
Methodology: https://510kreport.com/methodology