Ortho Clinical Diagnostics said yesterday that its Vitros insulin assay and calibrators won 510(k) clearance from the FDA.
The Raritan, N.J.-based company reported that the diabetes and pre-diabetes diagnostic test is slated to be commercially available in the 3rd quarter of this year.
The Vitros insulin assay is part of Ortho’s diagnostic platform for diabetes, which includes tests for HbA1c, glucose and microalbumin levels. The insulin assay can also help evaluate metabolic conditions, including pancreatic tumors and liver disease, according to Ortho.
“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,” chief operating officer Robert Yates said in prepared remarks. “Adding Insulin to Ortho’s Vitros menu demonstrates our continued momentum in product development.”
