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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.
 
DeviceCOBAS 4800 BRAF V600 MUTATION TEST
Generic NameSomatic gene mutation detection system
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP110020
Date Received04/25/2011
Decision Date08/17/2011
Product Code OWD 
Docket Number 11M-0601
Notice Date 08/19/2011
Advisory Committee Pathology
Clinical TrialsNCT01107418
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 
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