The FDA said it authorized Abbott Laboratories' BinaxNOW COVID-19 Ag Card, which the company says can give test results in 15 minutes, can produce results on a small card and costs $5 each.
The Trump administration said it will distribute the tests throughout the country.
"This is a major development that will help save more lives by further protecting America's most vulnerable and allow our country to remain open, get Americans back to work and get kids back to school," the White House said in a statement.
A clinical study showed the BinaxNOW card has a sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in suspected COVID-19 patients within the first seven days, Abbott said in a statement.
"This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card," Dr. Jeff Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement. "This means people will know if they have the virus in almost real-time."
With the BinaxNOW test, a health worker swabs a patient's nose and puts the sample onto the test card. Results then appear on the card -- a single line for a negative result and two lines for a positive result.
Abbott said it will ship tens of millions of the tests next month, and 50 million per month starting in October. The company will also launch a companion app, NAVICA, which allows those who test negative to display a temporary digital health pass to enter restricted facilities.
"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," said Abbott President and CEO Robert Ford.