AvertD and AvertD Buccal Sample Collection Kit

FDA PMA

Class III (US FDA PMA)

PMA P230032

by Autogenomics, Inc

Identity

Trade Name: AvertD and AvertD Buccal Sample Collection Kit FDA PMA
Generic Name: Opioid use disorder genetic risk variant detection system and collection kit FDA PMA

Identifiers

PMA Number: P230032 FDA PMA
FDA Product Code: QZH FDA PMA

Classification

Device Class: Class III FDA PMA
Advisory Committee: Clinical Toxicology FDA PMA
FDA Decision: APPR Approved FDA PMA

AvertD is a prescription, qualitative genotyping test designed to detect and identify 15 genetic polymorphisms in genomic DNA. It is used as part of a clinical evaluation to identify patients 18 years of age and older who may be at an elevated risk for developing opioid use disorder. The test is indicated for use in patients prior to receiving their first prescription of oral opioids for acute pain, such as those scheduled for a planned surgical procedure.

The AvertD Buccal Sample Collection Kit is intended for the non-invasive collection, transport, and storage of buccal specimens. Samples must be collected by a qualified healthcare professional to ensure the DNA is suitable for the AvertD test. This system is authorized under FDA PMA and is intended for use only in individuals 18 years or older.

Frequently asked questions

What is the purpose of the AvertD test?

AvertD is a qualitative genotyping test used to identify 15 specific genetic polymorphisms that may indicate an elevated risk for developing opioid use disorder in patients being evaluated for acute pain management.

Who is eligible to be tested with AvertD?

The test is indicated for individuals 18 years of age and older who are scheduled to receive a first prescription of oral opioids for acute pain, such as patients undergoing a planned surgical procedure.

How are samples collected for this test?

Samples are collected using the AvertD Buccal Sample Collection Kit, which is designed for the non-invasive collection, transport, and storage of buccal specimens by a qualified healthcare professional.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P230032	Class III	Active

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Manufacturer

Manufacturer: Autogenomics, Inc
FDA Applicant: AutoGenomics, Inc.

Sources (1)

FDA PMA P230032 24 fields · synced Sep 18, 2026