Immunoassay Blood Test For Amyloid Pathology Assessment
SET · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5840
Classification
FDA Product Code
SET
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5840
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.