ACON Laboratories Receives FDA Clearance for First 4-in-1 Respiratory Home Test

ACON Laboratories, Inc. has received 510(k) clearance from the U.S. Food & Drug Administration for its Flowflex Plus RSV + Flu A/B + COVID Home Test, representing a significant advancement in at-home diagnostic testing. This over-the-counter rapid antigen test enables consumers to simultaneously detect and differentiate between respiratory syncytial virus, influenza A, influenza B, and SARS-CoV-2 protein antigens using a single self-administered test.

The Flowflex Plus RSV + Flu A/B + COVID Home Test (K251749) is manufactured domestically at ACON's San Diego facility and represents multiple firsts in the home testing market. This lateral flow immunoassay is not only the first device to combine four analytes in one test but also marks the first FDA-cleared RSV home test available to consumers. Additionally, it is the first respiratory home test authorized for children aged 6-23 months when administered by an adult using ACON's proprietary nasal swab guard.

The implications of this development are substantial for public health management. With similar symptoms often complicating respiratory infection diagnosis, this 4-in-1 test provides critical differentiation capabilities that can inform early treatment decisions and potentially improve health outcomes. The test's availability for young children addresses a significant gap in pediatric home testing, offering parents a tool to quickly identify respiratory infections in vulnerable age groups.

Michael Lynch, VP of Sales & Marketing at ACON Laboratories, emphasized the product's significance for consumer health management. The test is expected to provide particular value for parents of young children, elderly individuals, immune-compromised populations, and those in regular contact with at-risk groups. As the Flowflex brand maintains its position as America's leading home test brand according to Circana Retail Sales Data, this new product expands the company's portfolio of consumer health solutions.

The Flowflex Plus RSV + Flu A/B + COVID Home Test will be available through major retailers later this year, with distribution information accessible at https://www.flowflexcovid.com. This advancement in home testing technology represents a shift toward more comprehensive diagnostic capabilities in consumer healthcare, potentially reducing healthcare system burdens by enabling earlier and more accurate at-home diagnosis of multiple respiratory conditions.