Product code QVU— Pathology
Invitae Common Hereditary Cancers Panel
- Classification name
- High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
- Device class
- Class 2
- Regulation
- 21 CFR 866.6095
- Advisory panel
- Pathology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QVU
FDA has cleared device under product code QVU, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QVU
Recent clearances under product code QVU
Data sourced from openFDA. This site is unofficial and independent of the FDA.