510(k) DEN200072
DEN200072 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "Lumipulse G ß-Amyloid Ratio (1-42/1-40)". The FDA issued a decision of De Novo Granted on May 4, 2022. The device falls under product code QSE (AlzheimerS Disease Pathology Assessment Test), a Class II device regulated under 21 CFR 866.5840. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 4, 2022
- Date Received
- November 20, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- AlzheimerS Disease Pathology Assessment Test
- Device Class
- Class II
- Regulation Number
- 866.5840
- Review Panel
- IM
- Submission Type
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.