Accelerate Diagnostics submits 510(k) application to FDA for PhenoTest BC Kit

Accelerate Diagnostics announced that the Company has submitted a 510(k) application to the FDA for Gram-negative menu expansion and breakpoint updates for the Accelerate PhenoTest BC kit. Included in the submission are additional escalation and de-escalation agents for Gram-negative organisms, additional antibiotics for Acinetobacter baumannii, and breakpoint updates. These updates add oral de-escalation antibiotic options for clinicians to use, which can assist with expediting patient discharge plans.