Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples. “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
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