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Inova announces FDA 510(k) clearance for its Aptiva system

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June 29, 2021–Inova Diagnostics announced FDA 510(k) clearance of its Aptiva system and Aptiva Celiac Disease IgA assay. Aptiva is a fully automated digital multi-analyte system for the clinical laboratory.

Aptiva uses a particle-based multi-analyte 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 and allows the laboratory to complete its workflow in a single shift. The system offers a 6.5-hour consumable walkaway time, and its 150-sample rack capacity reduces the number of daily interventions.

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