NUA · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5900
Classification
FDA Product Code
NUA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5900
Review panel
PA
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.