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Kenota Health Gets FDA Clearance, CLIA Waiver for Point-of-Care Allergy Test System

The story has been corrected to say the Kenota 1 System provides semi-quantitative IgE testing. 

NEW YORK — Canadian medical technology firm Kenota Health said Monday that its Kenota 1 System and Kenota 1 Total IgE assay has received 510(k) clearance and a CLIA waiver from the US Food and Drug Administration.

The testing system, which was submitted to the FDA for clearance about a year ago, is designed to provide semi-quantitative IgE testing in allergy clinics. The test measures total IgE levels using fingerstick blood samples to aid in the diagnosis of IgE-mediated allergic disorders, with results available in under 30 minutes.

Following the clearance of the system, Kenota said it aims to develop panels for specific IgE allergen tests, as well as pursue industry partnerships to help with the commercial rollout of its technology.