Immuno Concepts gets FDA 510(k) clearance for Image Navigator automated microscope

6 July 2016 (Last Updated July 6th, 2016 18:30)

Medical technology company Immuno Concepts has secured US Food and Drug Administration (FDA) 510(k) clearance for its Image Navigator automated microscope.

Medical technology company Immuno Concepts has secured US Food and Drug Administration (FDA) 510(k) clearance for its Image Navigator automated microscope.

The device serves to eliminate the inconveniences associated with the indirect immunofluorescent (IIF) test which is considered the gold standard for determination of anti-nuclear antibodies (ANA).

Immuno Concepts chief scientific officer Eric Hoy said: "The Image Navigator combines traditional fluorescent microscopy with modern digital technology to eliminate the repetitive, monotonous tasks of the fluorescent ANA, freeing the laboratory professional to perform other tasks until it is time to use the professional's skills in reading and interpreting the assay.

"This system truly saves labour, increases accuracy, and helps assure reproducibility of the fluorescent ANA test."

"The Image Navigator is based on a standard fluorescent microscope, and the ANA is performed using the same slides and reagents as are used in Immuno Concepts regular ANA kits.

"There are no magic ingredients or special conditions for the ANA test.

"The slides can be read manually on the Image Navigator microscope, or any other fluorescent microscope using standard techniques.

This system truly saves labour, increases accuracy, and helps assure reproducibility of the fluorescent ANA test."

Image Navigator is a software programme which is used to control a high-quality LED fluorescent microscope with a motorised stage to organise the indirect fluorescent antibody (IFA) teating and make it simple.

Images of each specimen are automatically captured and classified into possible negative and possible positive categories with a precision equivalent to 97%.

The images are then displayed for a final review and confirmation by the user.

The software features comprehensive separate review screens enabling the user to assign multiple patterns, order and read titers, and order additional testing.

The system features scalability in its operation and communicates with pipetting systems and with LIS hosts.