QVUClass II

High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

21 CFR 866.6095 / Pathology

QVU is the FDA product code for High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System., a class II device type, regulated under 21 CFR 866.6095. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2023-09-29, and no recalls.

Classification record

Product code: QVU
Device name: High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
FDA 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.
Regulation: 21 CFR 866.6095
Device class: Class II
Review panel: Pathology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QVU

By decision year

1 clearance under product code QVU with a decision year between 2023 and 2023, 2023 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QVU by decision year
Year	Clearances
2023	1

Applicants with the most clearances

Product code QVU

Applicants holding the most 510(k) clearances under product code QVU
Applicant	Clearances
Invitae Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QVU.

Recent clearances

Product code QVU

DEN210011Class IIInvitae Common Hereditary Cancers PanelInvitae Corporation / cleared 2023-09-29

Recent recalls

Product code QVU

FDA records show no recalls under product code QVU.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)