FDA product code QZH: Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

QZH is the FDA product code for opioid use disorder genetic risk variant detection system and collection kit. It is a Class III device, reviewed by the Clinical Toxicology panel. Devices under QZH reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.

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

Classification

Recalls for QZH devices

openFDA lists no recalls for product code QZH.

Frequently asked questions

What is FDA product code QZH?

QZH is the FDA product code for opioid use disorder genetic risk variant detection system and collection kit. It is a Class III device, reviewed by the Clinical Toxicology panel.

What device class is QZH?

Class III. Typical premarket route: PMA.

Next steps

• Run an FDA pathway report with predicate devices for product code QZH
• Run a recall and safety report across every QZH manufacturer
• Watch product code QZH for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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