BD Announces 510(k) Submission for Staph Superbug Test
BD Diagnostics, a segment of Becton Dickinson, has submitted its 510(k) submission for additional claims for the BD GeneOhm StaphSR assay.
This will be the first assay for rapid and simultaneous identification of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) colonized in the nasal passage, the company said.
The assay provides results from nasal swabs within two hours, BD said. It requires less time than traditional microbiology algorithms, which can take two days to generate results, the company added.
Since colonization is considered the major factor in wound contamination, the Society of Thoracic Surgeons has issued guidelines recommending rapid polymerase chain reaction screening tests for Staphylococcus aureus colonization prior to surgery, BD said.