|
Device | COLOGUARD |
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 |
Docket Number | 14M-1193 |
Notice Date | 08/13/2014 |
Advisory Committee |
Pathology |
Clinical Trials | NCT01260168
|
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | 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: |
S016 S012 S013 S014 S007 S001 S002 S003 S004 S005 S006 S008 S009 S015 S017 S018 S019 S011 S010 S021 S025 S026 S027 S028 S037 S038 S051 S055 S059 S060 S057 S022 S023 S020 S040 S041 S042 S029 S030 S031 S032 S033 S034 S035 S036 S045 S039 S043 S044 S024 S050 S046 S047 S048 S056 S049 S052 S053 S054 S062 S061 |