www.fdanews.com/articles/185545-mesa-biotech-garners-fda-clearance-and-clia-waiver-for-flu-test
Mesa Biotech Garners FDA Clearance and CLIA Waiver for Flu Test
February 8, 2018
Mesa Biotech obtained FDA 510(k) clearance and a Clinical Laboratory Improvements Amendments waiver for its Accula Flu A/Flu B test.
The disposable point-of-care test cassette is the first one to receive FDA clearance for use on the company’s polymerase chain reaction Accula testing platform, featuring a portable dock. It can provide test results in about 30 minutes using samples from nasal swabs.
The San Diego-based molecular diagnostic company received a CE Mark for the assay-specific product just last month.