FDA product code QDR: Plazomicin Test System, Immunoassay

QDR is the FDA product code for plazomicin test system, immunoassay. It is a Class II device, regulated under 21 CFR 862.3460 and reviewed by the Clinical Toxicology panel. Devices under QDR reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for QDR devices, 1 initiated in the last five years.

Definition

A plazomicin test system is a device intended to measure plazomicin in human specimens. Measurements obtained by this device are used in monitoring levels of plazomicin to ensure appropriate therapy in patients with complicated urinary tract infection.

Classification

Recalls for QDR devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.

Frequently asked questions

What is FDA product code QDR?

QDR is the FDA product code for plazomicin test system, immunoassay. It is a Class II device, regulated under 21 CFR 862.3460 and reviewed by the Clinical Toxicology panel.

What device class is QDR?

Class II, regulation 21 CFR 862.3460. Typical premarket route: 510(k).

Have QDR devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.

Next steps

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