Ultra-Performance LC-MS System Approved for Clinical Applications in China

By LabMedica International staff writers
Posted on 03 Jul 2014

An ultra-performance liquid chromatography – mass spectrometry (UPLC-MS) system has been approved by the Chinese Food and Drug Administration (CFDA) as a medical device for routine diagnostic applications and for screening of neonatal metabolites diseases.

The CFDA approval was granted for the ACQUITY UPLC TQD from Waters Corporation (Milford, MA, USA). A continuation of Waters' commitment to China and to growing clinical LC-MS applications worldwide, this represents the second Waters' mass spectrometer approved for in vitro diagnostic (IVD) applications in China (in 2008, the CFDA (formerly SFDA) approved a neonatal screening solution inclusive of the Waters Quattro micro mass spectrometer).

Image: The ACQUITY UPLC system, with technology that provides higher efficiencies with a much wider range of linear velocities, flow rates, and backpressures than optimized HPLC, and eliminates significant time and cost per sample (Photo courtesy of Waters Corporation).

An UPLC tandem quadrupole mass spectrometry (UPLC/MS/MS) system, the ACQUITY UPLC TQD (tandem quadrupole detector) is a benchtop, ultra-compact, tandem-quadrupole, mass detector-based system designed for routine UPLC/MS/MS analyses and quantitative applications, featuring high levels of MS selectivity, robustness, speed, and accuracy. To maximize the analytical advantages of UPLC, the ACQUITY TQD operates at the highest data acquisition rates. Integrated with the Waters ACQUITY UPLC System, the ACQUITY TQD gives class-leading analytical detection limits, resolution, and sample throughput.

"The approval by the CFDA of ACQUITY UPLC MS/MS system as a medical device is significant for two reasons. First and most importantly, this registration opens the door for millions of Chinese citizens to benefit from the gold standard of LC-MS diagnostic analysis," said Dr. Rohit Khanna, vice president of Worldwide Marketing and Informatics at Waters, "Secondly, this commitment to China's analytical scientists and laboratories reinforces Waters' strategy of expanding applications of our core chromatography and mass spectrometry technologies throughout the world. As of this decision by the CFDA, the ACQUITY UPLC, MS/MS system is registered as a medical device in 29 countries plus the European Economic Area, which includes an additional 30 countries."

Related Links:
Waters Corporation
ACQUITY UPLC TQD