US-based in vitro diagnostics company Accelerate Diagnostics has received 510(k) approval from the US Food and Drug Administration (FDA) for its Accelerate Arc system and BC kit.
The Accelerate Arc system and BC kit work as an automated positive blood culture sample preparation platform to fight against Sepsis and Antimicrobial Resistance (AMR).
The platform is intended for use with Bruker’s MALDI Biotyper CA System (MBT-CA System) and MBT-CA Sepsityper software extension.
Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification (ID) leveraging Bruker’s MBT-CA system.
It is designed for clinical laboratories, to eliminate the need for overnight culture methods and reduce the wait time for microbial ID results, said the company.
Accelerate Diagnostics president and CEO Jack Phillips said: “The FDA clearance of the Accelerate Arc system marks the beginning of an exciting journey in our broader innovation roadmap.
“Together with the Accelerate WAVE system we are positioned to empower laboratories to deliver faster, more actionable results to clinicians, ultimately enhancing patient care and outcomes.”
The diagnostics company said that its Accelerate Arc system uses the Bruker MBT-CA reference library for rapid identification (ID) of pathogens.
The ID, together with its upcoming Accelerate WAVE system for rapid antibiotic susceptibility testing (AST), will enable same-shift reporting to clinicians and Antimicrobial Stewardship teams.
The combined systems will help clinicians start optimal antibiotic treatment sooner, improving outcomes for conditions like sepsis, reducing resistance, and lowering hospital costs.
Also, the Accelerate Arc system replaces both overnight subcultures, and Laboratory Developed Test (LDT) methods with an automated, FDA-approved system, said the diagnostics company.
In addition to the Accelerate Arc system, the Accelerate Pheno system and Accelerate PhenoTest BC kit combine several technologies that reduce waiting time for clinicians.
The two systems fully automate sample preparation, identification and phenotypic antibiotic susceptibility testing within seven hours from positive blood cultures, said Accelerate.
