The U.S. Food and Drug Administration (FDA) granted 510(k) clearance and a CLIA waiver to Mesa Biotech for its Accula strep A molecular point-of-care test.
The strep A cassette detects group A Streptococcus bacterial nucleic acid by rapid polymerase chain reaction (PCR). It is approved for use in diagnosing children and adults and provides laboratory quality results within 30 minutes at the point of care.
