IDS-iSYS Total Testosterone

The IDS-iSYS Total Testosterone is an in vitro diagnostic assay for quantitatively measuring testosterone in human serum or plasma using the IDS-iSYS automated system. It is used to diagnose and monitor disorders of androgens (male sex hormones), including hypogonadism, delayed or precocious puberty, impotence in males, and hirsutism or virilization in females.

The device uses a competitive immunoassay with chemiluminescence detection, whereas the predicate uses electrochemiluminescence. Both employ biotinylated sheep monoclonal anti-testosterone antibodies and magnetic particles. The measuring range is 14–1500 ng/dL compared to the predicate's 2.50–1500 ng/dL, with slightly different reference intervals by age and sex.

CLSI EP17-A (limits of detection and quantitation), CLSI EP05-A3 (precision evaluation), CLSI EP06-Ed2 (linearity), CLSI EP07-A3 and EP07-ED3 (interference and cross-reactivity testing), CLSI EP09c (method comparison), CLSI EP35-Ed1 (sample matrix equivalence), and CLSI C28-A3 (reference intervals).

The candidate device is substantially equivalent to the Elecsys Testosterone II predicate because both are competitive immunoassays for quantifying total testosterone in serum or plasma with identical intended use, test principle, sample type, and antibody. Despite differences in detection method and measuring range, the device demonstrates comparable analytical performance, acceptable precision, linearity, specificity, and strong correlation (r=1.00) with a commercial reference method.