The FDA granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver to Quidel Corp. to market its Sofia 2 Lyme Fluorescent Immunoassay (FIA), a point-of-care diagnostic test.
Sofia 2 will be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human immunoglobulin M (IgM) and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens. The test is intended for use with the Sofia 2 analyzer to aid in the