# PQP · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/PQP

## Overview

- **Product Code:** PQP
- **Device Name:** Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.

## Recent Cleared Devices (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250027](/device/P250027.md) | Guardant360® Liquid CDx | Guardant Health, Inc. | May 19, 2026 | APPR |
| [P260004](/device/P260004.md) | Signatera™ CDx | Natera, Inc. | May 15, 2026 | APPR |
| [P240040](/device/P240040.md) | Oncomine Dx Express Test | Life Technologies Corporation | Jul 2, 2025 | APPR |
| [P240010](/device/P240010.md) | MI Cancer Seek | Caris Life Sciences | Nov 5, 2024 | APPR |
| [P230011](/device/P230011.md) | TruSight Oncology Comprehensive | Illumina, Inc. | Aug 21, 2024 | APPR |
| [P210011](/device/P210011.md) | xT CDx | Tempus Labs, Inc. | Apr 28, 2023 | APPR |
| [P210040](/device/P210040.md) | RESOLUTION ctDx FIRST | Exact Sciences Corporation | Dec 12, 2022 | APWD |
| [P200011](/device/P200011.md) | ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) | Pillar Biosciences | Jul 30, 2021 | APPR |
| [P200016](/device/P200016.md) | FoundationOne Liquid CDx | Foundation Medicine, Inc. | Nov 6, 2020 | APCB |
| [P200006](/device/P200006.md) | FoundationOne Liquid CDx (F1 Liquid CDx) | Foundation Medicine, Inc. | Oct 26, 2020 | APCB |
| [P190032](/device/P190032.md) | FoundationOne Liquid CDx (F1 Liquid CDx) | Foundation Medicine, Inc. | Aug 26, 2020 | APPR |
| [P200010](/device/P200010.md) | Guardant360 CDx | Guardant Health, Inc. | Aug 7, 2020 | APPR |
| [P170019](/device/P170019.md) | FoundationOne CDx | Foundation Medicine, Inc. | Nov 30, 2017 | APPR |
| [P160038](/device/P160038.md) | Praxis Extended RAS Panel | Illumina, Inc. | Jun 29, 2017 | APWD |
| [P160045](/device/P160045.md) | Oncomine Dx Target Test | Life Technologies Corporation | Jun 22, 2017 | APPR |
| [P160018](/device/P160018.md) | FoundationFocus CDxBRCA | Foundation Medicine, Inc. | Dec 19, 2016 | APWD |

## Top Applicants

- Foundation Medicine, Inc. — 5 clearances
- Guardant Health, Inc. — 2 clearances
- Illumina, Inc. — 2 clearances
- Life Technologies Corporation — 2 clearances
- Caris Life Sciences — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/PQP](https://fda.innolitics.com/productcode/PQP)

**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).

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