April 22, 2015—Inova Diagnostics announced the FDA has cleared Nova View, an automated digital indirect fluorescent assay microscope, through the de novo classification process. Nova View is the first FDA-cleared automated digital IFA microscope in the U.S. The Nova Lite DAPI ANA Kit, an IFA reagent indicated for use with Nova View, received 510(k) clearance at the same time.
ANA is the first line laboratory test for the diagnosis of systemic lupus erythematosus and other systemic autoimmune rheumatic diseases. IFA, as it is currently practiced in many laboratories, is time- and labor-intensive, subject to interpretation bias and other variables, such as the type of microscope and intensity of the light source. The workflow is manual, and prone to transcription errors, Inova said in a statement.
Nova View aims to address many shortcomings of the manual IFA process by reducing hands-on time, providing consistent reading and interpretation conditions, and generating digital images that can be archived. It provides patient sample traceability with positive patient identification and improves assay integrity by using Nova Lite barcoded IFA slides.