DEN200072 is an FDA 510(k) submission for the Lumipulse G ß-Amyloid Ratio (1-42/1-40). This device is classified as a Alzheimers Disease Pathology Assessment Test (Class II - Special Controls, product code QSE).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Not Cleared (DENG) decision on May 4, 2022.
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 | DEN200072 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 20, 2020 |
| Decision Date | May 04, 2022 |
| Days to Decision | 530 days |
| Submission Type | Direct |
| Review Panel | Immunology (IM) |
| Summary | — |
| 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. |