SAN DIEGO, CA., May 12, 2025 – ACON Laboratories, Inc., a leading global medical device manufacturer, announced today that its Flowflex® Plus COVID-19 + Flu A/B Home Test has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). The Flowflex Plus COVID-19 + Flu A/B Home Test (K250377) is an over-the-counter (OTC) rapid antigen test that can be administered in the comfort and privacy of consumers’ homes. This version of the test will continue to be manufactured domestically in ACON’s state-of-the-art San Diego, CA facility.
The Flowflex Plus COVID-19 and Flu A/B Home Test received Emergency Use Authorization (EUA) in July 2024, as a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory tract infection within the first five (5) days of symptom onset.
Additionally, as of April 4, 2025, the Flowflex Plus COVID-19 and Flu A/B Home Test expiration date has been extended by 6 months. New expiration dates can be checked online using the lot number printed on the test kit box.
“We are very proud to have received the FDA 510(k) for our COVID-19 and Flu A/B 3-in-1 home test that further enables individuals to take charge of their own health. Our test quickly determines which virus is causing symptoms so decisions can be made regarding treatment options. The Flowflex brand continues to be America’s #1 home test kit¹ and is carving the path for the future of reliable and affordable home tests,” said Michael Lynch, VP of Sales and Marketing.
Flowflex Plus COVID-19 and Flu A/B Home Tests are available at most major retailers. A list of authorized distributors and retail partners can be found at www.flowflexcovid.com.
¹ SOURCE: Circana Retail Sales Data (Units sold)
Contact: Rachel Stafford
RStafford@aconlabs.com