FDA product code QMN: Covid-19 Multi-Analyte Antigen Device

QMN is the FDA product code for covid-19 multi-analyte antigen device. It is a Not classified device, reviewed by the Microbiology panel. Devices under QMN reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 7 recalls for QMN devices, 3 initiated in the last five years.

Definition

A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information.

Classification

Recalls for QMN devices

7 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-01-03.

Frequently asked questions

What is FDA product code QMN?

QMN is the FDA product code for covid-19 multi-analyte antigen device. It is a Not classified device, reviewed by the Microbiology panel.

What device class is QMN?

Not classified. Typical premarket route: PMA.

Have QMN devices been recalled?

Yes: 7 product recalls across 6 recall events; the most recent began 2024-01-03.

Next steps

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