FDA provides EUA for COVID-19 breathalyzer
FDA provides EUA for COVID-19 breathalyzer

FDA provides EUA for COVID-19 breathalyzer

Lent by Sarah Silbiger / Getty Images

USAFood and Drug Administration has provided Emergency Use Authorization (EUA) for one breathalyzer who can detect COVID-19 within three minutes.

InspectIR’s COVID-19 Breathalyzer was shown to have the ability to detect five volatile organic compounds (VOCs) in the aldehyde and ketone families associated with SARS-CoV-2 infection from human respiration. The FDA only allowed its use for authorized settings by qualified and trained operators under the supervision of an authorized health care provider.

The test begins with the subjects exhaling into a tube connected to the test kit, similar to blowing a balloon into the air. The individual’s respiration 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 are currently not many details about the product on the company’s websitealthough this is expected to change as the company complies with FDA directives for EUA to be active.

“The FDA has reviewed the scientific information available to the FDA, including the information that supports the conclusions described in Section I above, and concludes that your product (as described in the scope of approval in this letter (Section II)) meets the criteria in Section 564 (c) of the Safety and Potential Efficiency Act, “the FDA said in a letter to John Redmondpresident and co-founder of InspectIR Systems.

Jacqueline O’Shaughnessy, Ph.D., the acting chief investigator for the FDA, wrote the letter on behalf of the regulator.

“Based on the overall scientific evidence available to the 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 to diagnose COVID-19, outweighs the known and potential risks of your product, “O’Shaughnessy wrote.

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

In addition, the FDA letter stated that InspectIR should label the breathalyzer correctly with approval guidelines, including the fact that it has not been approved or approved, but has been approved for emergency use in specific environments. The regulator also noted that it may revoke or terminate the approval as needed. Included in the approval is the waiver of certain requirements for good manufacturing practice.

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

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