Diagnostic reagents company Immuno Concepts said on Wednesday that it has passed the Histofluor Rodent LKS Rodent Tissue Slides for manual and Image Navigator use through the US Food and Drug Administration's (FDA) 510(k) process.

Following the US FDA's clearance, Histofluor Rodent Tissue Slides are available in both mouse and rat substrates and can be read manually or scanned using the innovative Image Navigator automated microscope, added the company.

The company stated the indirect immunofluorescent (IIF) test has long been the preferred method for determination of Anti-Mitochondrial Antibodies (AMA), Anti-Smooth Muscle Antibodies (ASMA) and Anti-Parietal Cell Antibodies. These autoantibodies are associated with several autoimmune diseases, including Pernicious Anemia or Autoimmune Gastritis, Primary Biliary Cholangitis (PBC) and Autoimmune Hepatitis.

According to the company, the same slides and reagents for the Histofluor Rodent Tissue Slides are used regardless of whether the slides are read manually or scanned on the Image Navigator.

In conjunction, the previously US FDA-Cleared Image Navigator eliminates the usual tedious labor of the IIF test, while still allowing the laboratory professional to control the interpretation and reporting of these tests, concluded the company.