MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)

The MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin is an in vitro diagnostic test that determines antimicrobial susceptibility of gram-positive bacteria (including Enterococcus faecium, Enterococcus species, and Staphylococcus species) by measuring minimum inhibitory concentrations (MIC) of daptomycin. Panels are rehydrated, inoculated with bacterial isolates, incubated overnight at 35°C, and read either manually or with automated MicroScan instrumentation to determine susceptibility classifications.

The proposed device uses the same overnight microdilution MIC susceptibility test technology, specimen type (isolated colonies), incubation temperature (35°C ± 1°C), atmosphere (aerobic), incubation time (16-20 hours), and reading method (automated or manual) as the predicate device. The key difference is the antimicrobial agent: daptomycin at 0.06-32 µg/mL concentration instead of vancomycin at 0.25-64 µg/mL.

The device performance was evaluated according to the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems (August 28, 2009). Testing also referenced the FDA Susceptibility Test Interpretive Criteria (STIC) webpage and comparison with CLSI frozen Reference Panels.

The proposed device is substantially equivalent because it uses identical methodology, specimen requirements, and operational parameters as the predicate (MicroScan Dried Gram-Positive MIC/Combo Panels with Vancomycin K150039), with the only difference being substitution of a different antimicrobial agent. External validation demonstrated acceptable performance metrics (Essential Agreement 90.8-100%, Categorical Agreement 92.0-99.5%) when compared to CLSI frozen reference panels across the three target organism groups, and reproducibility and quality control testing confirmed acceptable results with daptomycin.