# Neurologic Disease Risk Assessment Molecular Test
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SFC)
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