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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 EGFR RGQ PCR KIT
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
QIAGEN Strasse 1
Hilden 40724
PMA NumberP120022
Date Received11/30/2012
Decision Date07/12/2013
Product Code OWD 
Docket Number 13M-0851
Notice Date 07/15/2013
Advisory Committee Pathology
Clinical TrialsNCT00949650
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE THERASCREEN® EGFR RGQ PCR KIT. THIS DEVICE IS INDICATED FOR: THE THERASCREEN® EGFR RGQ PCR KIT IS A REAL-TIME PCR TEST FOR THE QUALITATIVE DETECTION OF EXON 19 DELETIONS AND EXON 21 (L858R) SUBSTITUTION MUTATIONS OF THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE IN DNA DERIVED FROM FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) NONSMALL CELL LUNG CANCER (NSCLC) TUMOR TISSUE. THE TEST IS INTENDED TO BE USED TO SELECT PATIENTS WITH NSCLC FOR WHOM GILOTRJF (AFATINIB), AN EGFR TYROSINE KINASE INHIBITOR (TKI), IS INDICATED. SAFETY AND EFFICACY OF GILOTRIF (AFATINIB) HAVE NOT BEEN ESTABLISHED IN PATIENTS WHOSE TUMORS HAVE L861Q, G719X, 87681, EXON 20 INSERTIONS, AND T790M MUTATIONS, WHICH ARE ALSO DETECTED BY THE THERASCREEN® EGFR RGQ PCR KIT. SPECIMENS ARE PROCESSED USING THE QIAAMP® DSP DNA FFPE TISSUE KIT FOR MANUAL SAMPLE PREPARATION AND THE ROTOR-GENE® Q MDX INSTRUMENT FOR AUTOMATED AMPLIFICATION ANDDETECTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 
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