FDA product code QHJ: Sensor, Glucose, Implanted, Non-Adjunctive Use

QHJ is the FDA product code for sensor, glucose, implanted, non-adjunctive use. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under QHJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for QHJ devices.

Definition

A non-adjunctive implanted 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 QHJ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-18.

Frequently asked questions

What is FDA product code QHJ?

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

What device class is QHJ?

Class III. Typical premarket route: PMA.

Have QHJ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2019-09-18.

Next steps

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