BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

The BD Phoenix Automated Microbiology System – GN Eravacycline is an in vitro antimicrobial susceptibility test (AST) that quantitatively determines the minimal inhibitory concentration (MIC) of the antibiotic eravacycline against Gram-negative Enterobacterales bacteria. It uses a broth-based microdilution method with automated growth detection to report susceptibility results within 16 hours.

The device uses the same automated broth-based microdilution technology, redox-indicator detection, and growth-based methodology as the predicate (tigecycline panel). Both employ two-fold serial dilutions, automated reading, and similar inoculation methods (manual PhoenixSpec nephelometer or automated Phoenix AP). The main differences are the specific antimicrobial agent (eravacycline vs. tigecycline), the concentration range (0.125–2 µg/mL vs. 0.25–16 µg/mL), and interpretation categories (susceptible/non-susceptible vs. susceptible/intermediate/resistant).

CLSI Performance Standards for Antimicrobial Susceptibility Testing (M100, 35th edition), CLSI Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically (M07, 11th edition), and FDA Class II Special Controls Guidance Document for Antimicrobial Susceptibility Test Systems (August 2009).

The device is substantially equivalent because it uses the identical Phoenix platform technology, methodology, and operational principles as the predicate K132909 (tigecycline). The only changes are the specific antimicrobial agent and its concentration range, which are routine additions to an established AST system. Performance data demonstrate >95% reproducibility and >90% essential agreement with CLSI reference methods across tested Enterobacterales species. Organism-specific limitations in the labeling address elevated very major error rates for certain species and MIC values, mitigating clinical risk despite some performance gaps.