| Device |
system, colorectal neoplasia, rna markers and hemoglobin detection |
| Definition |
The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy. |
| Physical State |
The device includes reagents, enzymes, and buffers to amplify and detect the assay targets. The test may include a specimen collection kit that may include a stool sample, collection bucket, and sample preservative |
| Technical Method |
The test uses polymerase chain reaction (PCR) to evaluate eukaryotic ribonucleic acid (RNA) markers and the enzymatic detection of occult hemoglobin in conjunction with other clinical characteristics to assess the likely presence of colorectal cancer and advanced adenomas. A single result, positive or negative, is determined based on the combination of results. Based on the combined results of the RNA markers, hemoglobin and smoking status, a single result, positive or negative is determined. |
| Target Area |
Human Clinical Specimens, Human Stool Samples |
| Review Panel |
Pathology |
|---|
| Product Code | SBB |
|---|
| 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 |
|
|
