Focus Diagnostics has received FDA 510(k) clearance and CLIA moderate complexity categorization for its Simplexa Group A Strep Direct Kit. Simplexa Group A Strep Direct is a real-time polymerase chain reaction (PCR) assay for the detection of Group A Streptococcus bacteria directly from throat swabs. Simplexa tests are designed for use on the 3M Integrated Cycler and employ real-time PCR technology to detect DNA or RNA in viruses, bacteria, and other analytes. Using a proprietary chemistry technique that eliminates the nucleic acid extraction process typical of molecular diagnostics, the tests are able to produce results in an hour. The Simplexa Group A Strep Direct test is intended for the in vitro qualitative detection of group A Streptococcus from throat swabs from human patients with signs and symptoms of pharyngitis, such as sore throat.