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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Devicetherascreen BRAF V600E RGQ PCR Kit
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
QIAGEN Strasse 1
Hilden 40724
PMA NumberP190026
Date Received09/30/2019
Decision Date04/15/2020
Product Code OWD 
Docket Number 20M-1290
Notice Date 04/17/2020
Advisory Committee
Clinical TrialsNCT02928224
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the therascreen BRAF V600E RGQ PCR Kit. The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US) instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001