510(k) K231348
K231348 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF". The FDA issued a decision of Substantially Equivalent on June 5, 2023. The device falls under product code QSE (AlzheimerS Disease Pathology Assessment Test), a Class II device regulated under 21 CFR 866.5840. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2023
- Date Received
- May 9, 2023
- Clearance Type
- Traditional
- 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.