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Nov 1, 2010

Ortho-Clinical Diagnostics Granted FDA Approval for Intact Parathyroid Hormone Assay

  • Ortho-Clinical Diagnostics received FDA 510(k) clearance for its Vitros intact Parathyroid Hormone (iPTH) Assay. The Vitros iPTH Assay measures intact parathyroid hormone levels and utilizes one protocol for both routine and intraoperative testing.

    The Vitros iPTH Assay is designed to run in a fully automated, random-access format on the Vitros ECi/ECiQ and 3600 Immunodiagnostic Systems. It can also be run on the Vitros 5600 Integrated System to combine clinical chemistry as well as routine and infectious disease immunoassay testing on a single platform. The company reports that results are available in 18 minutes.

    Measuring intact parathyroid hormone levels aids in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalacemia of malignancy. Complications of hyperparathyroidism are primarily related to the long-term effect of calcium imbalances in a patient's bones and bloodstream and may be associated with a number of health conditions such as cardiovascular disease, kidney stones, and osteoporosis.

    "By being able to run an iPTH test as part of routine assay testing on the Vitros Systems, laboratorians will be able to consolidate their workload onto a single system, helping to further improve productivity and efficiency,” says Bob Roda, vp, worldwide marketing, Clinical Laboratories and Donor Screening.

    Ortho-Clinical Diagnostics offers a range of assays that includes clinical chemistry tests that cover disease states including cardiology, oncology, endocrinology, and infectious disease. The Vitros ECi/ECiQ

    Immunodiagnostic System is a high-capacity immunoassay system with Intelligent Sample Management for routine and specialty testing designed for low- to mid-volume laboratories that require continuous processing. The Vitros 5600 Integrated System is a high-capacity system that integrates clinical chemistry and immunoassay testing on one platform using Sample Centered Processing.



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