Autosomal Recessive Carrier Screening Gene Mutation Detection System
PKB · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5940
Classification
FDA Product Code
PKB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5940
Review panel
PA
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.