AvertD and AvertD Buccal Sample Collection Kit
FDA premarket approval P230032 · decided 2023-12-19
Approval details
- PMA number
- P230032
- Trade name
- AvertD and AvertD Buccal Sample Collection Kit
- Generic name
- Opioid use disorder genetic risk variant detection system and collection kit
- Applicant
- AutoGenomics, Inc.
- Date received
- 2023-09-25
- Decision date
- 2023-12-19
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- QZH
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Carlsbad, CA
- 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 pa
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INFINITI SYSTEM (K060564) | AutoGenomics, Inc. | 2007-02-07 |