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Alzheimer’S Disease Pathology Assessment Test

QSE · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5840

Classification

FDA Product Code
QSE
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

In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.

Market data

Cleared 510(k) submissions
3
Registered establishments
4

Source

Authoritative
FDA Device Classification database
Machine
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