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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesomatic gene mutation detection system
PMA NumberP120022
Date Received12/07/2012
Decision Date07/12/2013
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 13M-0851
Notice Date 07/15/2013
Advisory Committee Pathology
Clinical Trials NCT00949650
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 and detection.
Approval Order Approval Order
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010