# DEN210011: Invitae Common Hereditary Cancers Panel

- Pathway: De Novo (Direct)
- Applicant: Invitae Corporation
- Decided: Sep 29, 2023 after 914 days
- Product code: QVU (High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.)
- Device class: 2
- Regulation: 21 CFR 866.6095
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Invitae Common Hereditary Cancers Panel is a qualitative high-throughput sequencing based in vitro diagnostic test system intended for analysis of germline human genomic DNA extracted from whole blood for detection of substitutions, small insertion and deletion alterations and copy number variants (CNV) in a panel of targeted genes. This test system is intended to provide information for use by qualified health care professionals, in accordance with professional guidelines, for hereditary cancer predisposition assessment and to aid in identifying hereditary genetic variants potentially associated with a diagnosed cancer. The test is not intended for cancer screening or prenatal testing. Results are intended to be interpreted within the context of additional laboratory results, family history, and clinical findings. The test is a single-site assay performed at Invitae Corporation.

Source page: https://510kreport.com/device/DEN210011
Methodology: https://510kreport.com/methodology