J&J's Dx unit gets FDA ok for parathyroid hormone test
This article was originally published in Clinica
Executive Summary
Ortho Clinical Diagnostics' Vitros intact parathyroid hormone assay has received 510(k) clearance from the US FDA. The test is used to help diagnose hyperparathyroidism, hypoparathyroidism or hypercalcaemia of malignancy. Hyperparathyroidism, or overactivity of the parathyroid glands, causes excess calcium production which can lead to problems such as kidney stones and osteoporosis. The test can also determine whether surgery to remove a suspected parathyroid tumour has been successful. It can be run on several of Ortho's analysers, including the Vitros ECi/ECiQ, the 3600 immunodiagnostic system, or the 5600 integrated system, which allows clinical chemistry and immunoassay testing on one platform. The assay provides results in 18 minutes.
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