510(k) K242706
K242706 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio". The FDA issued a decision of Substantially Equivalent on May 16, 2025. The device falls under product code SET (Immunoassay Blood Test For Amyloid Pathology Assessment), 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
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2025
- Date Received
- September 9, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay Blood Test For Amyloid Pathology Assessment
- Device Class
- Class II
- Regulation Number
- 866.5840
- Review Panel
- IM
- Submission Type
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.