Epi proColon

FDA Premarket Approval P130001 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

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.

DeviceEpi proColon
Generic NameSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
ApplicantEPIGENOMICS AG
Date Received2021-06-21
Decision Date2021-09-20
PMAP130001
SupplementS007
Product CodePHP 
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address EPIGENOMICS AG geneststr.5 berlin 

Supplemental Filings

Supplement NumberDateSupplement Type
P130001Original 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 IDPMASupp
04260400670036 P130001 000
04260400670029 P130001 000
04260400670012 P130001 000

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