SET — Immunoassay Blood Test For Amyloid Pathology Assessment Class II
FDA product code SET covers "Immunoassay Blood Test For Amyloid Pathology Assessment", a Class II medical device regulated under 21 CFR 866.5840. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SET
- Device Class
- Class II
- Regulation Number
- 866.5840
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
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.