Genetic Variant Detection And Health Risk Assessment System
PTA · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5950
Classification
FDA Product Code
PTA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5950
Review panel
IM
Medical specialty
Immunology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the persons overall risk of developing a disease.