The US Food and Drug Administration (FDA) has granted clearance through the de novo classification process for Inova Diagnostics’ NOVA View, an automated digital indirect fluorescent assay (IFA) microscope.
NOVA View comprises of a fluorescence microscope and software that acquires, analyses, stores and displays digital images of stained indirect immunofluorescent slides.
Developed to detect antinuclear antibodies (ANA), the new IFA microscope also received FDA 510(k) approval for NOVA Lite DAPI ANA Kit, an IFA reagent to be used with NOVA View.
The new automated digital IFA microscope, NOVA View, is the first FDA cleared microscope in the US, which will help laboratories that perform IFA for the detection of ANA.
ANA is the first line laboratory test for the diagnosis of systemic lupus erythematosus and other systemic autoimmune rheumatic diseases.
Simultaneously, the company also secured 510(k) clearance for NOVA Lite DAPI ANA Kit.
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NOVA View is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology and it can only be used with cleared or approved in-vitro diagnostic assays that are indicated for use with the device.
The device carries out ANA pattern interpretation and predicts a pattern specific endpoint titer, after confirmation by the operator.
Inova Diagnostics Assay Development director Gabriella Lakos said: "NOVA View is a technology that fundamentally changes the way IFA is performed in diagnostic laboratories.
"NOVA View will bring efficiency and reliability to this traditionally labour intensive and subjective area of diagnostic immunology."
Image: NOVA View automated digital IFA microscope. Photo: courtesy of PRNewswire/ Inova Diagnostics.