510(k) DEN210011

Invitae Common Hereditary Cancers Panel by Invitae Corporation — Product Code QVU

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: September 29, 2023
Date Received: March 29, 2021
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
Device Class: Class II
Regulation Number: 866.6095
Review Panel: PA
Submission Type

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.