K252163 is an FDA 510(k) clearance for the Elecsys Phospho-Tau (181P) Plasma. This device is classified as a Immunoassay Blood Test For Amyloid Pathology Assessment (Class II - Special Controls, product code SET).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 8, 2025, 90 days after receiving the submission on July 10, 2025.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5840. 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..
| 510(k) Number | K252163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2025 |
| Decision Date | October 08, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | SET — Immunoassay Blood Test For Amyloid Pathology Assessment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5840 |
| Definition | 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. |