Immunoassay Blood Test For Amyloid Pathology Assessment
An immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify amyloid pathology associated with Alzheimer's Disease in patients with signs and symptoms of cognitive decline, with results interpreted in conjunction with other clinical information to guide diagnostic and management decisions. It is classified as FDA Class II (510(k) required) under regulation 866.5840 in the Immunology specialty, with product code SET. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SET
- Device Class
- FDA class 2
- Regulation Number
- 866.5840
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.