Mesa Biotech Gets 510(k) Clearance for Strep A Test
Mesa Biotech has obtained the FDA’s 510(k) clearance for its Accula Strep A test, a diagnostic for Group A streptococcus infection.
The agency’s clearance allows the test to be used to diagnose Strep A in both children and adults in point-of-care settings and delivers laboratory quality results in 30 minutes, the company said.
The test is the third molecular diagnostic on the company’s Accula platform to receive FDA clearance. The company was granted Emergency Use Authorization for its SARS-CoV-2 test earlier in the year.