Epi proColon
FDA premarket approval P130001/S007 · decided 2021-09-20
Approval details
- PMA number
- P130001
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Epi proColon
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- New Day Diagnostics, LLC
- Date received
- 2021-06-21
- Decision date
- 2021-09-20
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Knoxville, TN
- Statement
- Approval for 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. T
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