Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
QZH · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QZH
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
TX
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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 persons 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