Definition: The Colorectal Neoplasia DNA Methylation And Hemoglobin Detection System Is A Qualitative, Non-invasive Device Used To Screen For The Detection Of Methylation Of Specific DNA Markers Associated With Colorectal Cancer And For The Presence Of Occult He
| Device Type ID | 5047 |
| Device Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Physical State | The Device May Be Intended For Manual Or Automated Assay Preparation. It May Include Specimen Collection And Preparation Kits Or Reagents, And May Utilize An Algorithm For Result Determination. |
| Technical Method | The Test Uses Bisulfite Conversion Of Methylated DNA And Polymerase Chain Reaction To Detect Methylation Of Specific DNA Markers, And Enzymatic Detection Is Used To Detect Occult Hemoglobin. |
| Target Area | Human Stool, Blood, Plasma |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PHP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5047 |
| Device | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Product Code | PHP |
| FDA Device Classification | Class 3 Medical Device |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Epigenomics Ag | II | Mar-16-2018 |
| 2 | Exact Sciences Corporation | II | Jun-01-2017 |