FDA product code PQP: Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

PQP is the FDA product code for next generation sequencing oncology panel, somatic or germline variant detection system. It is a Class III device, reviewed by the Pathology panel. Devices under PQP reach the market by PMA; FDA lists no cleared 510(k)s for it. 18 PMA applications cite this product code. FDA has posted 18 recalls for PQP devices, 10 initiated in the last five years.

Definition

A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.

Classification

Recalls for PQP devices

18 product recalls in 14 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2026-06-10.

Frequently asked questions

What is FDA product code PQP?

PQP is the FDA product code for next generation sequencing oncology panel, somatic or germline variant detection system. It is a Class III device, reviewed by the Pathology panel.

What device class is PQP?

Class III. Typical premarket route: PMA.

Have PQP devices been recalled?

Yes: 18 product recalls across 14 recall events; the most recent began 2026-06-10.

Next steps

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