FDA approves 510(k) clearance to Ortho’s VITROS Insulin reagent and Calibrators

Ortho Clinical Diagnostics, a US based in-vitro diagnostics company, announced that Ortho's VITROS Immunodiagnostic Products Insulin Reagent and Calibrators have received 510(k) clearance from the U.S. Food and Drug Administration (FDA), broadening Ortho's menu of tests that manage all aspects of diabetes and other pancreatic disorders. An important biomarker in diabetes and pre-diabetes testing, the assay is expected to be commercially available for use on all of Ortho's VITROS Immunodiagnostic and Integrated Systems in the U.S. during the third quarter of this year.

According to the World Health Organization, diabetes affects nine percent of people 18 years or older worldwide.  What's more, 191 million people with diabetes are currently undiagnosed.  Diabetes is managed as a chronic, lifelong condition with several significant co-morbidities, so it is vital that laboratories have a partner that supports the continuum of diabetes diagnostics.

"Our goal at Ortho is to provide the broad range of tools health care providers need to monitor and manage complex metabolic diseases and conditions like diabetes," said Robert Yates, Ortho's chief operating officer. "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 comprehensive diabetes menu, which includes HbA1c, glucose and microalbumin.  The VITROS Insulin Assay can also help to assess a broad range of metabolic conditions, including pancreatic tumors, liver disease, acromegaly, Cushing's disease, Familial Glucose-Galactose Malabsorption and obesity.