The US Meals and Drug Administration (FDA) has granted 510(okay) advertising and marketing clearance for the Flowflex COVID-19 Antigen Residence Take a look at. That is the primary FDA 510(okay) for an over-the-counter (OTC) fast antigen check for SARS-CoV-2, the virus that causes COVID-19, in line with the FDA.
ACON Laboratories’ Flowflex COVID-19 Antigen Residence Take a look at was initially licensed for emergency use in 2021 as a nasal swab check to be used at dwelling with no prescription.
The Flowflex COVID-19 Antigen Residence Take a look at is a visually learn check cleared for OTC dwelling use by symptomatic people inside six days of symptom onset. It’s cleared for people aged 14 years or older testing themselves, or adults testing people aged 2 years or older. In a research reviewed by the FDA, this check accurately recognized 89.8% of optimistic and 99.3% of detrimental samples in people with indicators and signs of higher respiratory an infection.
As with antigen checks licensed for emergency use, this check is meant for use no less than twice over three days with no less than 48 hours between checks. Because of this a symptomatic particular person with an preliminary detrimental check end result must be re-tested as soon as between 48 and 72 hours after the primary check utilizing an antigen check for COVID-19 or adopted up with a molecular COVID-19 check.
“We’re happy to obtain the primary FDA 510(okay) for an OTC COVID antigen check, which is symbolic of ACON’s management place out there,” says Michael Lynch, vice chairman of gross sales and advertising and marketing of ACON, in a launch. “That is additionally the primary FDA 510(okay) for an OTC fast antigen check for any infectious illness. We imagine this represents FDA’s dedication to empowering individuals to take larger cost of their healthcare. The complete ACON staff is happy to play a number one function in bringing reasonably priced and dependable dwelling diagnostics for infectious ailments to the general public, and hopefully this will probably be simply the primary of a number of such checks to be manufactured at our new state-of-the-art manufacturing facility in San Diego.”
The FDA reviewed the ACON Flowflex COVID-19 Antigen Residence Take a look at by the 510(okay) premarket evaluation pathway. A 510(okay) is a premarket submission made to the FDA to reveal {that a} new machine is considerably equal to a legally marketed predicate machine.
“This marks the newest step ahead in our efforts to assist check builders present People with continued choices for protected and efficient COVID checks that may be carried out fully at dwelling,” says Jeff Shuren, MD, JD, director of the FDA’s Heart for Units and Radiological Well being, in a launch. “The FDA continues to proactively work with check builders that need to market their merchandise past emergency use authorities. That is a part of the FDA’s broader effort to advance the event and availability of at-home checks for a wide range of medical situations to increase affected person entry to testing.”
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