FDA Clears First 2009 H1N1 Influenza Virus Test, Previously Available Under Emergency Use Authorization

June 10, 2010

The US Food and Drug Administration has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection.

The US Food and Drug Administration has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection.

Until this clearance, tests for 2009 H1N1 Influenza only were available through an emergency use authorization (EUA), which allows the FDA to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect.

Using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 (2009) test, manufactured by Focus Diagnostics, Inc. in Cypress, CA, simultaneously amplifies and detects two regions of the influenza virus genome and an internal control. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

On April 26, 2009, the US Department of Health and Human Services declared a public health emergency because of the 2009 H1N1 Influenza Virus. EUAs for devices will cease to be effective when the public health emergency declaration expires.

The US experienced its first wave of 2009 H1N1 Influenza Virus in the spring of 2009, followed by a second wave in the fall. The US Centers for Disease Control and Prevention estimates that between 43 million and 88 million cases of 2009 H1N1 occurred between April 2009 and March 13, 2010.