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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.
 
DeviceCOBAS EGFR MUTATION TEST
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
ROCHE
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 
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