The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for the Flowflex COVID-19 Antigen Home Test. This is the first FDA 510(k) for an over-the-counter (OTC) rapid antigen test for SARS-CoV-2, the virus that causes COVID-19, according to the FDA.
ACON Laboratories’ Flowflex COVID-19 Antigen Home Test was originally authorized for emergency use in 2021 as a nasal swab test for use at home without a prescription.
The Flowflex COVID-19 Antigen Home Test is a visually read test cleared for OTC home use by symptomatic individuals within six days of symptom onset. It is cleared for individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. In a study reviewed by the FDA, this test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.
As with antigen tests authorized for emergency use, this test is intended to be used at least twice over three days with at least 48 hours between tests. This means that a symptomatic individual with an initial negative test result should be re-tested once between 48 and 72 hours after the first test using an antigen test for COVID-19 or followed up with a molecular COVID-19 test.
“We are pleased to receive the first FDA 510(k) for an OTC COVID antigen test, which is symbolic of ACON’s leadership position in the market,” says Michael Lynch, vice president of sales and marketing of ACON, in a release. “This is also the first FDA 510(k) for an OTC rapid antigen test for any infectious disease. We believe this represents FDA’s commitment to empowering people to take greater charge of their healthcare. The entire ACON team is excited to play a leading role in bringing affordable and reliable home diagnostics for infectious diseases to the public, and hopefully this will be just the first of several such tests to be manufactured at our new state-of-the-art manufacturing facility in San Diego.”
The FDA reviewed the ACON Flowflex COVID-19 Antigen Home Test through the 510(k) premarket review pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
“This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a release. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”