NEW YORK – Revvity said on Friday that its Euroimmun subsidiary has received US Food and Drug Administration 510(k) clearance for an automated immunoassay that is used to aid the diagnosis of androgen disorders.
The IDS-iSys Free Testosterone chemiluminescence-based immunoassay (ChLIA) is used for the direct quantitative measurement of free testosterone in serum or plasma, with results within 48 minutes and an estimated throughput of about 60 tests per hour. It is designed for use on Revvity subsidiary Immunodiagnostic Systems' iSys and i10 instruments.
The IDS-iSys Free Testosterone assay is used to enhance diagnostic capabilities for conditions including hypogonadism, impotence, and polycystic ovarian syndrome, among other androgenital syndromes.
"This clearance reinforces our commitment to expanding the FDA-cleared menu for the Euroimmun family of ChLIA automation solutions with assays that serve diverse patient populations across all demographics," Jonathan Friend, general manager for Euroimmun US, said in a statement.