US-based diagnostic and medical device company ACON Laboratories has received the US Food & Drug Administration (FDA) 510(k) approval for its Flowflex Covid-19 Antigen Home Test.
Flowflex Covid-19 Antigen Home Test is a visually read test, approved for over-the-counter (OTC) at-home use by symptomatic individuals within six days of symptom onset.
The rapid antigen test is indicated for self-testing in people aged 14 years and above, and for testing by adults in children aged two years and above.
ACON said that its Flowflex Covid-19 Antigen Home Test is the first OTC rapid antigen test approved for SARS-CoV-2, which causes Covid-19.
The company intends to produce the Flowflex tests domestically, at its new 97,000ft2 manufacturing facility in San Diego, with plans to start distribution in 2024.
ACON Laboratories sales and marketing vice president Michael Lynch said: “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 the 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.”
In October 2021, the Flowflex Covid-19 Antigen Home Test was granted the FDA Emergency Use Authorisation (EUA), as an at-home simple nasal swab test without a prescription.
The EUA version test is indicated for use by both symptomatic and asymptomatic people.
Symptomatic individuals can test during the first seven days of the symptom onset, tested at least twice over three days, with at least 48 hours between tests.
Asymptomatic individuals can test three times over five days with at least 48-hour intervals.
ACON said that the EUA for the Flowflex test has not been revoked and will continue to supply the EUA version test kits through the upcoming cough and cold season.
In a study, the test accurately identified 89.8% of positive and 99.3% of negative samples in individuals with symptoms of upper respiratory infection, said the medical device company.
FDA Centre for Devices and Radiological Health director Jeff Shuren said: “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.
“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.”
