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Chinese FDA Approves Waters LC-MS System for IVD Use

NEW YORK(GenomeWeb) – Waters said today that the Chinese Food and Drug Administration has approved its Acquity UPLC I-Class IVD/Xevo TQ-S IVD LC-MS system for in vitro diagnostic use.

The system was approved for clinical analysis of various compounds including diagnostic markers and analytes for monitoring treatment.

"The practice of medicine is changing from a reactive approach to treating disease, to one that is more proactive and preventive. To facilitate this transition, better diagnostic and predictive tools are needed so that disease can be detected earlier or even prevented," Jeff Mazzeo, Waters' senior director, health sciences, said in a statement, adding that the company believed the Acquity/Xevo system could make "a significant impact" in this environment. 

The approval is part of a larger push by Waters to move certain of its instruments into the clinical setting. The company has also registered certain of its mass specs as Class I medical devices with the US Food and Drug Administration.