SAN DIEGO, CA, November 9, 2023 – ACON Laboratories, Inc. is proud to announce that the U.S. Food & 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 which causes COVID-19. The 510(k) version of the Flowflex COVID-19 Antigen Home Test will also be produced domestically, in ACON Laboratories’ new 97,000 square foot San Diego manufacturing facility. The 510(k) cleared Flowflex COVID-19 Antigen Home Test is indicated for use only by symptomatic individuals within the first six days after symptom onset. An initial negative result must be followed by retesting between 48 and 72 hours after the first test. ACON intends to start distribution of the 510(k) cleared test in 2024 and plans additional communications to the market in advance of distribution.
The Flowflex COVID-19 Antigen Home Test received Emergency Use Authorization (EUA) in October 2021, as a simple nasal swab test which is easily performed at home without a prescription. It rapidly gained popularity during the Omicron variant surge as ACON manufactured and delivered hundreds of millions of tests to the market. Since then, the intended use of the EUA version of the Flowflex COVID-19 Antigen Home Test has evolved based on the collective knowledge of SARS-CoV-2 infections in a population which has been increasingly vaccinated and/or exposed to the virus. Currently, the EUA version is indicated for use by both symptomatic and asymptomatic people. If symptomatic, the test can be performed during the first seven days after symptom onset when tested at least twice over three days with at least 48 hours between tests. Asymptomatic individuals can use it when testing three times over five days with at least 48 hours between tests.
The EUA for the Flowflex COVID-19 Antigen Home Test has not been revoked, and ACON Laboratories will continue to supply EUA test kits to meet the public’s demand for safe and easy home testing through the upcoming cough and cold season.
Michael Lynch, Vice President of Sales & Marketing, commented, “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. 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.”
Risk Statement: Improper use of COVID-19 Antigen tests can pose significant risk since they may lead to false negative test results. False-negative antigen test results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are grouped into cohorts (that is, they are housed together) in health care, long-term care, and other facilities based on these false test results. Actions to limit exposure based on false-negative results might not be taken, such as isolating people, limiting contact with family and friends, and limiting ability to work.
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