Flowflex Becomes First At-Home COVID-19 Antigen Test Cleared Through 510(k)

The test is among the first of a wave of products initially authorized for emergency use by the US FDA that are now pursuing traditional approval pathways to stay on the market. 

Packaging for Flowflex COVID-19 antigen home test
• Source: Shutterstock

The US Food and Drug Administration’s effort to transition products cleared through Emergency Use Authorizations to traditional regulatory pathways hit another milestone on 9 November as ACON Laboratories’ Flowflex became the first COVID-19 antigen home test to receive a 510(k) clearance.

In addition to being the first test cleared via 510(k), Flowflex is also the first antigen test and the first...

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