Browse hierarchy: [Pathology (PA)](/submissions/PA) → [Subpart G — Tumor Associated Antigen Immunological Test Systems](/submissions/PA/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems) → [21 CFR 866.6095](/submissions/PA/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6095) → QVU — High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

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

_Pathology · 21 CFR 866.6095 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/QVU

## Overview

- **Product Code:** QVU
- **Device Name:** High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
- **Regulation:** [21 CFR 866.6095](/submissions/PA/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6095)
- **Device Class:** 2
- **Review Panel:** [Pathology](/submissions/PA)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN210011](https://fda.innolitics.com/submissions/PA/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/QVU/DEN210011.md) | Invitae Common Hereditary Cancers Panel | Invitae Corporation | Sep 29, 2023 | DENG |

## Top Applicants

- Invitae Corporation — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/PA/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/QVU](https://fda.innolitics.com/submissions/PA/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/QVU)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com