Sept. 4, 2024—QuidelOrtho has received FDA 510(k) clearance for its Vitros syphilis assay, intended for the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum-specific antigens in human serum and plasma using the automated Vitros 3600, 5600, and XT 7600 systems. The presence of antibodies to TP-specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. The assay is not intended for blood and tissue donor screening.