Inova Diagnostics has received de novo approval from the US Food and Drug Administration (FDA) for its NOVA View, an automated digital indirect fluorescent assay microscope (IFA).
NOVA View is an automated system, which includes fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides.
Developed to detect antinuclear antibodies (ANA), the new IFA microscope has also received FDA 510(k) approval for NOVA Lite DAPI ANA Kit, an IFA reagent to be used with NOVA View.
Inova Diagnostics CEO Roger Ingles said: "Inova Diagnostics is pleased to launch the first automated digital IFA microscope in the US."
NOVA View will assist in the detection and classification of certain antibodies by indirect immunofluorescence technology and can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device.
It carries out ANA pattern interpretation and predicts a pattern specific endpoint titer, after confirmation by the operator.
The results are then recorded electronically in a transcription free and paperless work environment, and all digital images are archived for future review.
According to the company, the presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to assist in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases.
Image: NOVA View automated digital IFA microscope. Photo: courtesy of PRNewswire/ Inova Diagnostics.