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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
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP110020
Date Received04/25/2011
Decision Date08/17/2011
Product Code
OWD[ Registered Establishments with OWD ]
Docket Number 11M-0601
Notice Date 08/19/2011
Advisory Committee Pathology
Clinical Trials NCT01107418
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the cobas 4800 braf v600 mutation test. This device is indicated for: the cobas 4800 braf v600 mutation test is an in vitro diagnostic device intended for the qualitative detection of the braf v600e mutation in dna extracted from formalin-fixed, paraffin-embedded human melanoma tissue. The cobas 4800 braf v600 mutation test is a real-time pcr test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the braf v600e mutation for treatment with vemurafenib.
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 S013 S014 S015 S017 S018