FDA product code OTG: Non-Sars Coronavirus Multiplex Nucleic Acid Assay

OTG is the FDA product code for non-sars coronavirus multiplex nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. Devices under OTG reach the market by 510(k); FDA lists no cleared 510(k)s for it.

Definition

A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus infections if used in conjunction with other clinical and laboratory findings.

Classification

Recalls for OTG devices

openFDA lists no recalls for product code OTG.

Frequently asked questions

What is FDA product code OTG?

OTG is the FDA product code for non-sars coronavirus multiplex nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.

What device class is OTG?

Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).

Next steps

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