Accelerate Diagnostics, Inc. 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(R) 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.
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- Accelerate Diagnostics Submits 510(K) Application to FDA for Gram-Negative Menu Expansion and Breakpoint Updates for the Accelerate Phenotest(R) BC Kit