On Jan. 19, 2021, Mesa Biotech announced it had received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the FDA for its Acculaﾙ Strep A test. The Strep A cassette, for the molecular detection of Group A Streptococcus bacterial nucleic acid by rapid PCR, was cleared for diagnosing both children and adults and provides laboratory quality results in 30 minutes at the point of care.