Premarket Approval (PMA)

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.

• Device: COLOGUARD
• Classification Name: system, colorectal neoplasia, dna methylation and hemoglobin detection
• Generic Name: system, colorectal neoplasia, dna methylation and hemoglobin detection
• Applicant: Exact Sciences Corporation; 441 charmany drive; madison, WI 53719
• PMA Number: P130017
• Date Received: 06/07/2013
• Decision Date: 08/11/2014
• Product Code: PHP [ Registered Establishments with PHP ]
• Docket Number: 14M-1193
• Notice Date: 08/13/2014
• Advisory Committee: Pathology
• Clinical Trials: NCT01260168; NCT01397747; NCT01600209
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH 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 Order

Approval Order

Summary

Summary of Safety and Effectiveness

Labeling

Labeling

Post-Approval Study

Show Report Schedule and Study Progress

• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 ; S010 S011 S012 S013 S014 S015 S016