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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCologuard
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantExact Sciences Corporation
441 Charmany Drive
Madison, WI 53719
PMA NumberP130017
Supplement NumberS051
Date Received03/02/2022
Decision Date04/13/2022
Product Code PHP 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a minor change in the wording of the Indications for Use. Cologuard Stool DNA-Based Colorectal Cancer Screening Test is indicated forCologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. Cologuard is for use with the Cologuard® collection kit and the following instruments: BioTek ELx808 Absorbance Microplate Reader; Applied Biosystems 7500 Fast Dx Real-Time PCR; Hamilton Microlab STARlet; and the Exact Sciences System Software with Cologuard Test Definition.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 colonoscopy. Cologuard is indicated to screen adults of either sex, 45 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.
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