SFC — Neurologic Disease Risk Assessment Molecular Test Class II

FDA Device Classification

Classification Details

Product Code
SFC
Device Class
Class II
Regulation Number
866.5850
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN240032firalisAPO-Easy Genotyping kitJune 12, 2025