Vitros immunodiagnostic products insulin reagent and calibrators from Ortho Clinical Diagnostics, Raritan, NJ, have received FDA premarket notification (510(k)) clearance. An important biomarker in diabetes and prediabetes testing, the assay is expected to be commercially available for use on all of Ortho’s Vitros immunodiagnostic and integrated analyzers in the United States during the third quarter of this year.

According to the World Health Organization, diabetes affects 9% of people 18 years or older worldwide.1 Diabetes is managed as a chronic, lifelong condition with several significant comorbidities.

“Our goal at Ortho is to provide the broad range of tools healthcare providers need to monitor and manage complex metabolic diseases and conditions like diabetes,” says Robert Yates, chief operating officer at Ortho. “Adding insulin to Ortho’s Vitros menu demonstrates our continued momentum in product development.”

The Vitros insulin assay is part of Ortho’s Vitros systems’ diabetes menu, which includes HbA1c, glucose, and microalbumin.  The Vitros insulin assay can also help to assess a broad range of metabolic conditions, including acromegaly, Cushing’s disease, familial glucose-galactose malabsorption liver disease, obesity, and pancreatic tumors.

For more information, visit Ortho Clinical Diagnostics.