Waters’ UPLC-MS system listed as medical device

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  • Published: Jan 6, 2016
  • Author: Jon Evans
  • Source: Waters Corporation
  • Suppliers: Waters Corporation
  • Channels: HPLC / Base Peak
thumbnail image: Waters’ UPLC-MS system listed as medical device

Waters Corporation has announced that the Waters ACQUITY UPLC I-Class IVD/Xevo TQ-S micro IVD System is now manufactured as a US FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). As a result, clinical laboratories can now access leading innovations in liquid chromatography (LC) and mass spectrometry (MS) technology for the analysis of a variety of compounds that include diagnostic indicators in laboratory-developed tests.

"Waters pioneered the use of LC-MS as medical devices over a decade ago," said Jeff Mazzeo, senior director, health sciences for Waters Division. "We are committed to expanding the number of Waters LC-MS systems listed as medical devices. Today we are pleased to announce that the ACQUITY UPLC I-Class IVD/Xevo TQ-S micro IVD System joins the family of Waters LC-MS in vitro diagnostic medical devices."

Using LC-MS technology, clinical laboratories can perform qualitative and quantitative analyses of patients' samples to aid clinicians in many ways. Over recent years, the scope of use of LC-MS in the clinical environment has widened and the number of tests that can be developed and validated by diagnostic laboratory service providers has grown rapidly.

The ACQUITY UPLC I-Class IVD/Xevo TQ-S micro IVD System features Waters' UltraPerformance LC technology coupled with a benchtop tandem-quadrupole mass spectrometer designed to provide the highest acquisition rates in UPLC-MS/MS quantitative analysis. Xccelerated Ion Transfer (XIT) electronics, using SpaceWire technology, allow this instrument to acquire data at high speeds without compromising performance. In addition, extensions to tried-and-tested StepWave ion optics continue Waters’ long history in the delivery of sensitive and robust LC-MS systems.

(Photo of the UPLC I-Class IVD/Xevo TQ-S micro IVD System courtesy of Waters.)

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