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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceTherascreen EGFR RGQ PCR Kit
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
QIAGEN Strasse 1
Hilden 40724
PMA NumberP120022
Supplement NumberS016
Date Received07/28/2017
Decision Date01/12/2018
Product Code OWD 
Advisory Committee Pathology
Clinical TrialsNCT00949650
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for extending the labeling claim of the therascreen® EGFR RGQ PCR Kit to include detection of EGFR mutations L861Q, G719X and S768I, to aid in identifying patients with NSCLC for whom safety and efficacy of GILOTRIF® (afatininb) has been established.