| Device |
system, colorectal neoplasia, dna methylation and hemoglobin detection |
| 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 hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. |
| 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 |
|---|
| Product Code | PHP |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
