K242706 is an FDA 510(k) clearance for the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. This device is classified as a Immunoassay Blood Test For Amyloid Pathology Assessment (Class II - Special Controls, product code SET).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on May 16, 2025, 249 days after receiving the submission on September 9, 2024.
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 | K242706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2024 |
| Decision Date | May 16, 2025 |
| Days to Decision | 249 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. |