Epi proColon

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Premarket Approval P130001

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

The epi procolon test is a qualitative in vitro diagnostic test for the detection of methylated septin 9 dna in edta plasma derived from patient whole blood specimens. Methylation of the target dna sequence in the promoter region of the sept9_v2 transcript has been associated with the occurrence of colorectal cancer (crc). The test uses a real-time polymerase chain reaction (pcr) with a fluorescent hydrolysis probe for the methylation specific detection of the septin 9 dna target. The epi procolon test is indicated to screen adults of either sex, 50 years or older, defined as average risk for crc, who have been offered and have a history of not completing crc screening. Tests that are available and recommended in the uspstf 2008 crc screening guidelines should be offered and declined prior to offering the epi procolon test. Patients with a positive epi procolon test result should be referred for diagnostic colonoscopy. The epi procolon test results should be used in combination with physician's assessment and individual risk factors in guiding patient management.

• Device: Epi proColon
• Classification Name: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
• Generic Name: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
• Applicant: EPIGENOMICS AG
• Date Received: 2013-01-03
• Decision Date: 2016-04-12
• Notice Date: 2016-05-20
• PMA: P130001
• Supplement: S
• Product Code: PHP
• Docket Number: 16M-1168
• Advisory Committee: Pathology
• Expedited Review: Yes
• Combination Product: No
• Applicant Address: EPIGENOMICS AG geneststr.5 berlin
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P130001		Original Filing
S007	2021-06-21	Real-time Process
S006
S005	2019-08-06	30-day Notice
S004	2018-02-20	30-day Notice
S003
S002	2016-05-10	Normal 180 Day Track No User Fee
S001	2016-04-29	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
04260400670036	P130001	000
04260400670029	P130001	000
04260400670012	P130001	000