K231348 is an FDA 510(k) clearance for the Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF. This device is classified as a Alzheimers Disease Pathology Assessment Test (Class II - Special Controls, product code QSE).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 5, 2023, 27 days after receiving the submission on May 9, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5840. In Vitro Test To Determine Whether A Patient Presenting With Cognitive Impairment And Being Evaluated For Ad And Other Causes Of Cognitive Decline Will Test Positive Or Negative For Amyloid Plaques Or Neurofibrillary Tangles As Measured By Pet Imaging Agents..
| 510(k) Number | K231348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2023 |
| Decision Date | June 05, 2023 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | QSE — Alzheimers Disease Pathology Assessment Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5840 |
| Definition | In Vitro Test To Determine Whether A Patient Presenting With Cognitive Impairment And Being Evaluated For Ad And Other Causes Of Cognitive Decline Will Test Positive Or Negative For Amyloid Plaques Or Neurofibrillary Tangles As Measured By Pet Imaging Agents. |