September 2021—Inova Diagnostics announced FDA 510(k) clearance of its Aptiva system and Aptiva Celiac Disease IgA assay. Aptiva is a fully automated digital multianalyte system for the clinical laboratory. Aptiva received the CE mark in August 2020.
Aptiva uses a particle-based multianalyte technology (PMAT) that processes multiple analytes simultaneously from a patient sample. PMAT enables Aptiva to deliver up to 720 results per hour using a 12-analyte test cartridge. The system offers a 6.5-hour consumable walkaway time, and its 150-sample rack capacity reduces the number of daily interventions.
Aptiva plans to include seven additional autoimmune disease states and has more than 60 analytes in various stages of advanced development.
Inova Diagnostics, 858-586-9900