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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Generic Namesdna-based colorectal cancer screening test
PMA NumberP130017
Supplement NumberS005
Date Received12/04/2015
Decision Date12/23/2015
Product Code
PHP[ Registered Establishments with PHP ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change the following: use of software spreadsheet workbook for automated data processing in place of manual calculations of acceptance criteria for quality control (qc) test; revision of the upper specification limit for qc blank positivity for markers btact and act; relocation of the qc laboratories from the first floor to the second floor within the same facility; and relocation of the labeling and dispensing activities into other rooms on the same floor.