FDA product code QSN: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

QSN is the FDA product code for orthopedic infection microbial multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3988 and reviewed by the Microbiology panel. Devices under QSN 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 QSN devices, 1 initiated in the last five years.

Definition

A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.

Classification

Recalls for QSN devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-22.

Frequently asked questions

What is FDA product code QSN?

QSN is the FDA product code for orthopedic infection microbial multiplex nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3988 and reviewed by the Microbiology panel.

What device class is QSN?

Class II, regulation 21 CFR 866.3988. Typical premarket route: 510(k).

Have QSN devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2026-04-22.

Next steps

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