PMA P130017S017
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S017
- Product code
- PHP
- Decision date
- 2017-11-06
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- Approval for changes to the Cologuard Hemoglobin Assay Process and Reagents. The device, as modified, will be marketed under the trade name Cologuard and is indicated for use as follows: Cologuard 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® Epoch 2 Absorbance Microplate Reader; Applied Biosystems® 7500 Fast Dx Real-Time PCR; Hamilton Microlab® STARlet; and the Exact Sciences System Software with Cologuard Test Definition. This assay is to be performed at Exact Sciences Laboratory, located at 145 E. Badger Rd, Suite 100, Madison, Wisconsin.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.
Current openFDA PMA Record#
- Device
- Cologuard
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S017
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2017-11-06
- Decision code
- APPR
- Date received
- 2017-05-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the Cologuard Hemoglobin Assay Process and Reagents. The device, as modified, will be marketed under the trade name Cologuard and is indicated for use as follows: Cologuard 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® Epoch 2 Absorbance Microplate Reader; Applied Biosystems® 7500 Fast Dx Real-Time PCR; Hamilton Microlab® STARlet; and the Exact Sciences System Software with Cologuard Test Definition. This assay is to be performed at Exact Sciences Laboratory, located at 145 E. Badger Rd, Suite 100, Madison, Wisconsin.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.