FDA gives 510(k) clearance for BD Phoenix CPO detect test to identify carbapenemase-producing organisms- Becton Dickinson

Becton, Dickinson and Company announced the FDA has given 510(k) clearance of the BD Phoenix CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections.

Comment:The test streamlines laboratory workflow by routine, concurrent testing of CPO and susceptibility to one panel. Conventional phenotypic methods for CPO detection can take up to 96 hours, whereas the BD Phoenix CPO detect test can accurately detect CPOs in under 36 hours.