SFC · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5850
Classification
FDA Product Code
SFC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5850
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.