High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
QVU · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 866.6095
Classification
FDA Product Code
QVU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6095
Review panel
PA
Medical specialty
Pathology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only.