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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
Generic Namesomatic gene mutation detection system
4300 hacienda drive
po box 9002
pleasanton, CA 94588
PMA NumberP120019
Date Received11/08/2012
Decision Date05/14/2013
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 13M-0594
Notice Date 05/17/2013
Advisory Committee Pathology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the cobas® egfr mutation test. The cobas® egfr mutation test is a real-time pcr test for the qualitative detection of exon 19 deletions and exon 21 (l858r) substitution mutations ofthe epidermal growth factor receptor (egfr) gene in dna derived from formalin-fixed paraffin-embedded (ffpet) human non-small cell lung cancer (nsclc) tumor tissue. The test is intended to be used as an aid in selecting patients with metastatic nsclc for whom tarceva® (erlotinib), an egfr tyrosine kinase inhibitor (tk1), is indicated. Specimens are processed using the cobas® dna sample preparation kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012