PMA P130017S005
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S005
- Product code
- PHP
- Decision date
- 2015-12-23
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order 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.
Current openFDA PMA Record#
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S005
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2015-12-23
- Decision code
- OK30
- Date received
- 2015-12-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.