# OWD · Somatic Gene Mutation Detection System

_ ·  · Class 3_

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

## Overview

- **Product Code:** OWD
- **Device Name:** Somatic Gene Mutation Detection System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.

## Recent Cleared Devices (19 of 19)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P220005](/device/P220005.md) | CRCDx RAS Mutation Detection Assay Kit | Entrogen, Inc. | Sep 29, 2023 | APPR |
| [P210002](/device/P210002.md) | therascreen PDGFRA RGQ PCR Kit | QIAGEN GmbH | Jun 29, 2023 | APPR |
| [P200014](/device/P200014.md) | cobas® EZH2 Mutation Test | Roche Molecular System, Inc. | Jun 18, 2020 | APPR |
| [P190026](/device/P190026.md) | therascreen BRAF V600E RGQ PCR Kit | QIAGEN GmbH | Apr 15, 2020 | APPR |
| [P190004](/device/P190004.md) | therascreen PIK3CA RGQ PCR Kit | QIAGEN GmbH | May 24, 2019 | APCB |
| [P190001](/device/P190001.md) | therascreen PIK3CA RGQ PCR Kit | QIAGEN GmbH | May 24, 2019 | APPR |
| [P180043](/device/P180043.md) | therascreen FGFR RGQ RT-PCR Kit | QIAGEN GmbH | Apr 12, 2019 | APPR |
| [P170041](/device/P170041.md) | Abbott RealTime IDH1 | Abbott Molecular, Inc. | Jul 20, 2018 | APPR |
| [P170005](/device/P170005.md) | Abbott RealTime IDH2 | Abbott Molecular, Inc. | Aug 1, 2017 | APPR |
| [P160040](/device/P160040.md) | LeukoStrat CDx FLT3 Mutation Assay | Invivoscribe Technologies, Inc. | Apr 28, 2017 | APPR |
| [P150044](/device/P150044.md) | cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | Sep 28, 2016 | APCB |
| [P150047](/device/P150047.md) | cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | Jun 1, 2016 | APCB |
| [P140023](/device/P140023.md) | COBAS KRAS MUTATION TEST | Roche Molecular Systems, Inc. | May 7, 2015 | APPR |
| [P110027](/device/P110027.md) | THERASCREEN KRAS RGQ PCR KIT | QIAGEN GmbH | May 23, 2014 | APPR |
| [P120022](/device/P120022.md) | THERASCREEN EGFR RGQ PCR KIT | QIAGEN GmbH | Jul 12, 2013 | APPR |
| [P120014](/device/P120014.md) | BIOMERIEUX THXID BRAF ASSAY KIT | bioMerieux, Inc. | May 29, 2013 | APWD |
| [P120019](/device/P120019.md) | COBAS EGFR MUTATION TEST | Roche | May 14, 2013 | APPR |
| [P110030](/device/P110030.md) | THERASCREEN KRAS RGQ PCR KIT | QIAGEN Manchester, Ltd. | Jul 6, 2012 | APWD |
| [P110020](/device/P110020.md) | COBAS 4800 BRAF V600 MUTATION TEST | Roche Molecular Systems, Inc. | Aug 17, 2011 | APPR |

## Top Applicants

- QIAGEN GmbH — 7 clearances
- Roche Molecular Systems, Inc. — 4 clearances
- Abbott Molecular, Inc. — 2 clearances
- Entrogen, Inc. — 1 clearance
- Invivoscribe Technologies, Inc. — 1 clearance

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

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