NEW YORK – Inova Diagnostics announced on Tuesday that its Aptiva System and Aptiva Celiac Disease IgA Assay received 510(k) clearance from the US Food and Drug Administration.
The Aptiva system is a fully automated digital multianalyte, high-throughput processor for the clinical laboratory that received CE marking last August. It has a sample rack capacity of 150, which the company said in a statement reduces the number of daily interventions in the lab. It also has a 6.5-hour consumable walkaway time, San Diego-based Inova added.
Aptiva uses particle-based multianalyte technology that processes multiple analytes simultaneously from a patient sample, allowing it to deliver up to 720 results per hour using a 12-analyte test cartridge.
In addition to the celiac test, the system will include seven other autoimmune disease states and Inova has more than 60 analytes in various stages of advanced development for Aptiva, the company said.
"Aptiva's broad disease and syndromic-based analyte portfolio is a breakthrough that fundamentally enhances the utility of diagnostic testing in the laboratory," Michael Mahler, VP of research and development at Inova, said in a statement. "Aptiva will bring efficiency and reliability to the autoimmune laboratory and provide expanded information to clinicians for management of patients with autoimmune diseases."