ACON Laboratories, Inc., a global medical device manufacturer based in San Diego, CA, announced today that its Flowflex Plus RSV + Flu A/B + COVID Home Test has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). This over-the-counter (OTC) rapid antigen test is designed for home use and can simultaneously detect and differentiate respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 (COVID-19) from a single self-collected nasal swab.
The test represents several industry firsts: it is the first FDA-cleared 4-in-1 respiratory home test, the first FDA-cleared RSV home test, and the first respiratory infection home test authorized for children aged 6-23 months when administered by an adult using ACON's proprietary nasal swab guard. The product will be manufactured domestically at ACON's facility in San Diego, CA.
According to the company, this innovation addresses the challenge of overlapping symptoms among respiratory infections. Rapid identification enables early treatment decisions, potentially improving health outcomes. The test is particularly relevant for vulnerable populations, including young children, the elderly, and immunocompromised individuals.
Michael Lynch, VP of Sales & Marketing, commented, 'We are excited to introduce this game-changing 4-in-1 home test. This product further demonstrates our commitment to enabling consumers to take charge of their own health.' He added that the test would bring peace of mind to parents and caregivers of at-risk groups.
Flowflex is already the leading home test brand in the United States by unit sales, according to Circana retail data. The Flowflex Plus RSV + Flu A/B + COVID Home Test is expected to be available at major retailers later this year. A list of authorized distributors and retail partners can be found at www.flowflexcovid.com.
