Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
Basic Information
- Device Name
- Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
- Trade Name
- AvertD and AvertD Buccal Sample Collection Kit
- PMA Number
- P230032
- Device Class
- FDA Class 3
- Product Code
- QZH
- Generic Name
- Opioid use disorder genetic risk variant detection system and collection kit
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Toxicology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 19, 2023
- Date Received
- September 25, 2023
- Expedited Review
- N
- Docket Number
- 23M-5501
Advisory Committee Statement
AvertD is a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA isolated from buccal samples collected from individuals 18 years of age and older. The test may be used as part of a clinical evaluation and risk assessment to identify patients who may be at elevated risk for developing opioid use disorder (OUD). The test is indicated for use only in patients prior to receiving a first prescription of oral opioids for 4-30 days for acute pain, such as in patients scheduled to undergo a planned surgical procedure and who consent to having the test performed. The AvertD Buccal Sample Collection Kit is intended for use in the non-invasive collection, transport and storage of buccal specimens. DNA from the buccal sample will be suitable for use in AvertD. Buccal samples are collected by a qualified healthcare professional. For use only in individuals 18 years or older.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QZH | Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit | FDA class 3 | Unknown |