| Device |
opioid use disorder genetic risk variant detection system and collection kit |
| Definition |
A qualitative in vitro molecular test that detects select variants in genomic DNA isolated from human specimens. Results of the test provide users with a genetic risk assessment of developing Opioid Use Disorder (OUD) and are intended to aid users with informed decision-making regarding the use of oral opioids for acute pain relief. The test may not include all variants associated with a risk of developing OUD and is not intended to describe a person’s overall risk of developing OUD. Results from the system are intended to be used in combination with clinical information and should not be the sole determinant in diagnosing, counseling, or making prescribing decisions |
| Physical State |
The test system may consist of reagents, instrumentation, quality control and software. The collection kit is a specimen collection device. |
| Technical Method |
The test system uses technology to amplify, detect, and identify specific nucleic acid variants. The collection kit collects DNA in saliva and stabilizes it for transport or storage. |
| Target Area |
Human clinical specimens |
| Review Panel |
Toxicology |
|---|
| Product Code | QZH |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| 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 |
