Cologuard
FDA premarket approval P130017/S017 · decided 2017-11-06
Approval details
- PMA number
- P130017
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cologuard
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2017-05-22
- Decision date
- 2017-11-06
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- 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
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