bioMérieux Receives FDA 510(k) Clearance for its Vitek Compact Pro ID/AST system

Yesterday, bioMérieux announced the FDA cleared the company’s Vitek Compact Pro ID/AST system to be utilized for microorganism identification (ID) and antibiotic susceptibility testing (AST). This system looks to help clinical labs identify infectious diseases and combat antimicrobial resistance, as well as industrial laboratories to identify contaminants for ensuring consumer safety. ¹

The Vitek Compact Pro ID/AST system combines new diagnostic technology with the company’s predecessor, the Vitek 2 Compact. With an ergonomically advanced design and a simplified workflow, it further enhances the user experience and improves overall efficiency as the laboratory technician has to spend less time for sample loading and processing. It offers efficient workflows, fastest routine ID/AST results and microbiology expertise for accurate and confident diagnostics insights. Ideally suited for small and medium-sized laboratories, Vitek Compact Pro will also enable laboratories transitioning from manual workflows to benefit from automation efficiencies. ¹

For industrial applications, the system will be used for routine identification of pathogens to ensure the quality and safety of food, pharmaceutical, and cosmetic products.¹

The commercial launch of Vitek Compact Pro is initially planned in select countries, followed by global launch starting in the second quarter of 2025.¹

The Impact of Sepsis and Antimicrobial Resistance

Every year 11 million people worldwide die of sepsis² and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria.³ In the United States alone, there are 1.7 million cases of sepsis, and at least 350,000 deaths annually, according to the Centers for Disease Control and Prevention (CDC).⁴

Sepsis is the body’s extreme response to an infection. When patients become septic, they are in a serious medical condition that requires timely treatment, otherwise their bodies can begin to fail and shut down. Screening and getting patients the correct diagnosis for bacterial infections can play a role in preventing sepsis.

References
1.bioMérieux receives FDA 510(k) Clearance for its Vitek Compact Pro, a new ID/AST system to fight against antimicrobial resistance. bioMérieux press release. March 18, 2025. Accessed March 19, 2025.
https://www.biomerieux.com/corp/en/journalists/press-releases/vitek-compact-pro-fda-clearance-antimicrobial-resistance.html
2.Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet (London, England). 2020;395(10219):200-11.
3.Murray CJ. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0.
4.About Sepsis. CDC. Last updated March 8, 2024. Accessed March 19, 2025.
https://www.cdc.gov/sepsis/about/index.html