Somatic Gene Mutation Detection System
FDA product code OWD · Class III (high risk) · Pathology
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.
0510(k) clearances
19PMA approvals
13recalls
PMA approvals
- P220005 CRCDx RAS Mutation Detection Assay Kit · Entrogen, Inc. · 09/29/2023
- P210002 therascreen PDGFRA RGQ PCR Kit · QIAGEN GmbH · 06/29/2023
- P200014 cobas® EZH2 Mutation Test · Roche Molecular System, Inc. · 06/18/2020
- P190026 therascreen BRAF V600E RGQ PCR Kit · QIAGEN GmbH · 04/15/2020
- P190004 therascreen PIK3CA RGQ PCR Kit · QIAGEN GmbH · 05/24/2019
- P190001 therascreen PIK3CA RGQ PCR Kit · QIAGEN GmbH · 05/24/2019
- P180043 therascreen FGFR RGQ RT-PCR Kit · QIAGEN GmbH · 04/12/2019
- P170041 Abbott RealTime IDH1 · Abbott Molecular, Inc. · 07/20/2018
- P170005 Abbott RealTime IDH2 · Abbott Molecular, Inc. · 08/01/2017
- P160040 LeukoStrat CDx FLT3 Mutation Assay · Invivoscribe Technologies, Inc. · 04/28/2017
- P150044 cobas EGFR MUTATION TEST v2 · Roche Molecular Systems, Inc. · 09/28/2016
- P150047 cobas EGFR MUTATION TEST v2 · Roche Molecular Systems, Inc. · 06/01/2016
- P140023 Cobas Kras Mutation Test · Roche Molecular Systems, Inc. · 05/07/2015
- P110027 Therascreen Kras RGQ PCR Kit · QIAGEN GmbH · 05/23/2014
- P120022 Therascreen Egfr RGQ PCR Kit · QIAGEN GmbH · 07/12/2013
- P120014 Biomerieux Thxid Braf Assay Kit · bioMerieux, Inc. · 05/29/2013
- P120019 Cobas Egfr Mutation Test · Roche · 05/14/2013
- P110030 Therascreen Kras RGQ PCR Kit · QIAGEN Manchester, Ltd. · 07/06/2012
- P110020 Cobas 4800 Braf V600 Mutation Test · Roche Molecular Systems, Inc. · 08/17/2011
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2665-2023 Class II | therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx…Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag… | Qiagen GmbH | 08/22/2023Open, Classified |
| Z-1652-2022 Class II | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010Increased occurrence rate of false positive results, lead to a false positive sample result that could… | Qiagen Sciences LLC | 07/20/2022Open, Classified |
| Z-1651-2022 Class II | therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711Increased occurrence rate of false positive results, lead to a false positive sample result that could… | Qiagen Sciences LLC | 07/20/2022Open, Classified |
| Z-1650-2022 Class II | therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721Increased occurrence rate of false positive results, lead to a false positive sample result that could… | Qiagen Sciences LLC | 07/20/2022Open, Classified |
| Z-0952-2022 Class II | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from… | Qiagen Sciences LLC | 02/25/2022Open, Classified |
| Z-0951-2022 Class II | therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from… | Qiagen Sciences LLC | 02/25/2022Open, Classified |
| Z-0083-2022 Class II | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number…False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR… | Roche Molecular Systems, Inc. | 09/03/2021Open, Classified |
| Z-0937-2021 Class II | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast…Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within… | Qiagen Sciences LLC | 12/11/2020Terminated |
| Z-2254-2016 Class II | cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA:…During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion… | Roche Molecular Systems, Inc. | 04/05/2016Terminated |
| Z-1830-2016 Class II | cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation…An error was found within the Hungarian translations of the cobas EGFR Mutation Test v2 Instructions for Use… | Roche Molecular Systems, Inc. | 03/15/2016Terminated |
| Z-1320-2015 Class III | cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assayFalse positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test… | Roche Molecular Systems, Inc. | 01/13/2015Terminated |
| Z-0999-2015 Class III | cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the…cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator. | Roche Molecular Systems, Inc. | 12/18/2014Terminated |
| Z-0188-2013 Class III | cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems…It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into… | Roche Molecular Systems, Inc. | 07/31/2012Terminated |