Ortho Clinical Diagnostics has received the US Food and Drug Administration (FDA) 510(k) clearance for VITROSintact Parathyroid Hormone (iPTH) Assay.
The VITROSiPTH assay measures intact parathyroid hormone levels and utilises one protocol for both routine and intraoperative testing with results available in 18 minutes.
The VITROSiPTH assay is designed to be run in a fully automated, random access format on the VITROSECi/ECiQ and 3600 immunodiagnostic systems, and can also be run on the VITROS5600 integrated system to combine clinical chemistry, routine and infectious disease immunoassay testing on a single platform with equivalent analytical results.
Clinical Laboratories and Donor Screening worldwide marketing vice president Bob Roda said that the launch of the VITROSiPTH Assay underscores the commitment of Ortho Clinical Diagnostics to expand its menu offerings to best meet the needs of clinical laboratories and their patients.
“By being able to run an iPTH test as part of routine assay testing on the VITROSSystems, laboratorians will be able to consolidate their workload onto a single system, helping to further improve productivity and efficiency,” Roda said.