Marcy l’Étoile, France, April 7 2023 – bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the VITEK® REVEAL™, formerly known as SPECIFIC REVEAL™ Rapid AST System.
Every year 11 million people worldwide die of sepsis and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria. For clinicians to save patients’ lives and rapidly optimize therapies, fast and accurate antimicrobial susceptibility testing (AST) results and interpretation are critical. In addition to improving patient outcomes, rapid AST also reduces global antimicrobial resistance (AMR) burden by enabling the implementation of effective institutional Antimicrobial Stewardship (AMS) programs.
bioMérieux has been committed for decades to fighting sepsis and AMR. As part of this strategy, Specific Diagnostics was acquired in 2022. The U.S. based company has developed the SPECIFIC REVEAL™ Rapid AST System. This rapid, modular, antimicrobial-susceptibility test platform that can deliver actionable results for Gram-negative bacteria directly from positive blood cultures in an average of five and a half hours1 enabling same-day treatment decision-making for patients suffering from bacteremic sepsis.
The instrument seamlessly integrates with bioMérieux’s unique and comprehensive Sepsis Solution. For this reason it was decided to rename the system to VITEK® REVEAL™ fitting perfectly in our VITEK® ID/AST Brand.
The rapid AST system VITEK® REVEAL™ is already available on-market under CE-IVDD (assay panel) and IVDR (instrument) designation across Europe. In August 2022, the FDA granted the system with its Breakthrough Device Designation, which is reserved for medical devices that offer significant advantages over existing cleared alternatives, for which no approved alternatives exist, and/or for which device availability is in the best interest of patients2.
The FDA 510(k) clearance will allow its commercialization in the U.S. and other countries recognizing this authorization.
1. Tibbetts R, George S, Burwell R, Rajeev L, Rhodes PA, Singh P, Samuel L. Performance of the Reveal Rapid Antibiotic Susceptibility Testing System on Gram-Negative Blood Cultures at a Large Urban Hospital. J Clin Microbiol. 2022 Jun 15;60(6):e0009822.
- PR_VITEK_REVEAL_FDA_submission_20230407 VF.pdf
- 212 KB