COLOGUARD
FDA premarket approval P130017/S005 · decided 2015-12-23
Approval details
- PMA number
- P130017
- Supplement
- S005
- Supplement type
- 30-Day Notice
- 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
- 2015-12-04
- Decision date
- 2015-12-23
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- CHANGE THE FOLLOWING: USE OF SOFTWARE SPREADSHEET WORKBOOK FOR AUTOMATED DATA PROCESSING IN PLACE OF MANUAL CALCULATIONS OF ACCEPTANCE CRITERIA FOR QUALITYCONTROL (QC) TEST; REVISION OF THE UPPER SPECIFICATION LIMIT FOR QC BLANK POSITIVITY FOR MARKERSBTACT AND ACT; RELOCATION OF THE QC LABORATORIES FROM THE FIRST FLOOR TO THE SECOND FLOORWITHIN THE SAME FACILITY; AND RELOCATION OF THE LABELING AND DISPENSING ACTIVITIES INTO OTHER ROOMSON THE SAME FLOOR.
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