PhAST Corp. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the PhAST instrument and the PhAST Blood Culture Gram-negative Panel (PhAST BC GN Panel, K253316), according to an announcement.

The PhAST BC GN Panel is a phenotypic in vitro diagnostic assay that determines antimicrobial susceptibility directly from blood cultures flagged as positive by a continuous monitoring system, without subculture. The panel reports a categorical interpretation - Susceptible, Intermediate, or Resistant - for 15 antimicrobials, and is indicated for monomicrobial samples containing Acinetobacter spp., Enterobacterales, or Pseudomonas aeruginosa. Organism identity from a separate FDA-cleared method is required.

The PhAST BC GN Panel time from sample loading to susceptibility results is 99 ± 6 min for Enterobacterales and Acinetobacter spp., and 141 ± 6 min for P. aeruginosa (mean ± standard deviation). PhAST uses single-cell, time-lapse video microscopy and computer vision to observe how individual bacterial pathogens respond to antimicrobials, rather than inferring resistance from genetic markers. 

The PhAST BC GN Panel is categorized as Moderate Complexity under CLIA. Sample preparation takes under one minute of hands-on time.

The clearance was supported by a clinical study at four sites, three of them U.S. clinical laboratories. The overall Categorical Agreement was 97.3%, with a major error rate of 0.9% and a very major error rate of 0.2%.

Read PhAST's announcement for more information