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. |
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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 |
Supplement Number | S051 |
Date Received | 03/02/2022 |
Decision Date | 04/13/2022 |
Product Code |
PHP |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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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