510(k) K253240
K253240 is an FDA 510(k) premarket notification submitted by C2N Diagnostics, LLC for the device "PrecivityAD2 Test". The FDA issued a decision of Substantially Equivalent on August 19, 2026. The device falls under product code SET (Immunoassay Blood Test For Amyloid Pathology Assessment), a Class II device regulated under 21 CFR 866.5840.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2026
- Date Received
- September 29, 2025
- 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.