FDA authorizes first COVID-19 diagnostic test using breath samples

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FDA - Center for Devices and Radiological Health

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FDA Authorizes InspectIR COVID-19 Breathalyzer Test

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19 Breathalyzer test is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The authorization for the InspectIR COVID-19 Breathalyzer test is an example of the FDA’s continued commitment to support the development of innovative, appropriately accurate and reliable diagnostic tests that increase testing options for COVID-19.

The InspectIR COVID-19 Breathalyzer test:

  • Is authorized to be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.
  • Is authorized to be performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes.
  • Is for people ages 18 and older without symptoms or other epidemiological reasons to suspect COVID-19.

Positive test results should be confirmed with a molecular test. Negative results do not rule out SARS-CoV-2 infection. Health care providers should consider negative test results along with a patient’s recent exposures, history, and presence of other clinical signs and symptoms consistent with COVID-19 and should perform follow up testing if necessary for patient management.

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If you have questions about this EUA announcement, contact the Division of Industry and Consumer Education