510(k) K261686
K261686 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Phospho-Tau (217P) Plasma". The FDA issued a decision of Substantially Equivalent on August 19, 2026. The device falls under product code SET (Immunoassay Blood Test For Amyloid Pathology Assessment), a Class II device regulated under 21 CFR 866.5840. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2026
- Date Received
- May 21, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay Blood Test For Amyloid Pathology Assessment
- Device Class
- Class II
- Regulation Number
- 866.5840
- Review Panel
- IM
- Submission Type
An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimers Disease who have signs and symptoms of cognitive decline. The results of the test are to be interpreted in conjunction with other patient clinical information.