FDA Grants EUA for COVID-19 Breathalyzer

The U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) for a breathalyzer that can detect COVID-19 within three minutes.

InspectIR’s COVID-19 Breathalyzer was found to have the ability to detect five volatile organic compounds (VOCs) in the aldehyde and ketone families linked with SARS-CoV-2 infection from persons’ breaths. The FDA allowed its use only for authorized settings by qualified and trained operators under the supervision of a licensed healthcare provider.

The test starts with the subjects exhaling into a tube connected to the test kit, similar to blowing up a balloon. The subject’s breath is then captured in the device and analyzed for COVID-19 markers and spectrometry. InspectIR’s device evaluates and displays the results in less than three minutes using its proprietary software.

There’s currently not much detail on the product on the company’s website, though this is expected to change as the company complies with FDA directives for the EUA to be active.

“FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, and concludes that your product (as described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness,” the FDA said in a letter to John Redmond, the president and co-founder of InspectIR Systems.

Jacqueline O’Shaughnessy, Ph.D., the acting chief scientist for the FDA, wrote the letter on the regulatory body’s behalf.

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product,” O’Shaughnessy wrote.

The FDA outlined the conditions that InspectIR needs to comply with and accomplish for the EUA to be in effect. This includes following FDA-mandated labeling requirements, making information available on the InspectIR website and reporting to the Division of Microbiology, the Office of Health Technology 7: Office of In Vitro Diagnostics and Radiological Health, the Office of Production Evaluation and the Center for Devices and Radiological Health in case of any false negatives, false positives or other significant deviations.

Courtesy of Sarah Silbiger/Getty Images

In addition, the FDA letter stated that InspectIR should properly label the breathalyzer with clearance guidelines, including the fact that it has not been approved or cleared but has been authorized for emergency use in specific settings. The regulator also noted that it can revoke or end the authorization as needed. Included in the approval is the waiver of certain good manufacturing practice requirements.

“This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act,” the letter concluded.