FDA product code PQF: Sensor, Glucose, Invasive, Non-Adjunctive

PQF is the FDA product code for sensor, glucose, invasive, non-adjunctive. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under PQF reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 4 recalls for PQF devices, 2 initiated in the last five years.

Definition

A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

Classification

Recalls for PQF devices

4 product recalls in 3 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2022-05-24.

Frequently asked questions

What is FDA product code PQF?

PQF is the FDA product code for sensor, glucose, invasive, non-adjunctive. It is a Class III device, reviewed by the Clinical Chemistry panel.

What device class is PQF?

Class III. Typical premarket route: PMA.

Have PQF devices been recalled?

Yes: 4 product recalls across 3 recall events; the most recent began 2022-05-24.

Next steps

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