NEW YORK – BioMérieux announced Tuesday that it has obtained 510(k) clearance from the US Food and Drug Administration for its Vitek Compact Pro microorganism identification and antibiotic susceptibility testing (ID/AST) system.
The system features an ergonomic design and simple workflow, the firm said in a statement, and is suited for small and medium clinical labs and industrial testing settings, as well as labs transitioning away from manual workflows. The system is intended to help combat antimicrobial resistance as a component of antimicrobial stewardship.
The new system "delivers fast, accurate, and reproducible results" that are comparable to the company's Vitek 2 and Vitek 2 Compact systems, Jennifer Zinn, BioMérieux's executive VP of clinical operations, said in the statement.
Céline Roger-Dalbert, executive VP of research and development at BioMérieux, noted that "the ergonomic features, a new intuitive user interface, and an updated software with one of the most comprehensive knowledge database makes Vitek Compact Pro highly appealing to both clinical and industrial laboratories."
For industrial applications, the system can be used for identification of pathogens as part of quality and safety testing for food, pharmaceuticals, and cosmetics, BioMérieux said.
The Vitek Compact Pro system is a next-generation version of the Vitek 2 Compact, according to a spokesperson, and leverages the firm's phenotype-based AST and Advanced Expert System interpretation software. The complete Vitek ID/AST portfolio also includes the Vitek MS Prime for rapid microbial identification using MALDI-TOF, and the Vitek Reveal for rapid AST using a novel metabolic signature-sensing method.
The Marcy l’Étoile, France-based firm said commercial launch of the Vitek Compact Pro will begin in select countries followed by a global launch starting in the second quarter of 2025.
BioMérieux obtained 510(k) clearance last year for its Vitek Reveal ID/AST system as part of its current five-year growth plan.