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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.
 
DeviceCOLOGUARD
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantExact Sciences Corporation
441 Charmany Drive
Madison, WI 53719
PMA NumberP130017
Date Received06/07/2013
Decision Date08/11/2014
Product Code PHP 
Docket Number 14M-1193
Notice Date 08/13/2014
Advisory Committee Pathology
Clinical TrialsNCT01260168
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE COLOGUARD. COLOGUARD IS INTENDED FOR THE QUALITATIVE DETECTION OF COLORECTAL NEOPLASIA ASSOCIATED DNA MARKERS AND FOR THE PRESENCE OF OCCULT HEMOGLOBIN IN HUMAN STOOL. A POSITIVE RESULT MAY INDICATE THE PRESENCE OF COLORECTAL CANCER (CRC) OR ADVANCED ADENOMA (AA) AND SHOULD BE FOLLOWED BY DIAGNOSTIC COLONOSCOPY. COLOGUARD IS INDICATED TO SCREEN ADULTS OF EITHER SEX, 50 YEARS OR OLDER, WHO ARE AT TYPICAL AVERAGE-RISK FOR CRC. COLOGUARD IS NOT A REPLACEMENT FOR DIAGNOSTIC COLONOSCOPY OR SURVEILLANCE COLONOSCOPY IN HIGH RISK INDIVIDUALS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S051 S040 S041 S042 S017 S018 S019 S008 S009 S015 S012 S013 
S014 S011 S010 S007 S001 S002 S003 S004 S005 S006  S016 
S023 S029 S030 S033 S034 S035 S036 S025 S026 S027 S037 S038 
S056 S057 S020 S022 S021 S024 S028 S043 S044 S032 S031 S039 
S052 S053 S047 S048 S055 S045 S054 S049 S050 S046 S059 S060 
S061 S062 
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