Agilent’s next-generation clinical edition triple quadrupole LC/MS system, the K6460S, is listed as a Class I medical device with the U.S. Food and Drug Administration. The system includes a preconfigured liquid chromatograph and mass spectrometer, as well as the clinical edition of Agilent MassHunter software, which provides an easy-to-use and intuitive submission-to-reporting workflow.
When performing diagnostic assays, the K6460S provides the specificity and selectivity that clinical labs require, delivering robust results with more accuracy, and increasing the reliability of target compound detection in complex matrices.
“We are pleased to announce the launch of the K6460S, our newly validated LC/MS system in the United States,” said Monty Benefiel, vice president and general manager of Agilent's Mass Spectrometry Division. “Agilent has a strong reputation in providing reliable and routine solutions to clinical laboratories. We believe that the strength and robustness of our technologies, combined with our depth of expertise in our services and support offerings, makes Agilent a powerful partner for clinical diagnostic labs.”
“Using TQ LC/MS increases the specificity, selectivity, and accuracy of many clinical diagnostic assays compared to traditional binding assays,” said Ken Lewis, chief executive officer of OpAns, LLC. “The fully validated Agilent K6460S is a robust and reliable platform that boosts productivity via technology purpose-built for diagnostic workflows.”
It was also announced in January 2020 that the Agilent LC-MS/MS had been approved by China's national drug administration (NMPA) for use in the China domestic clinical diagnosis market.
Agilent is a leader in providing IVD medical devices to improve the quality of health care globally and has driven investment in this key area to develop and launch robust, reliable LC-MS/MS IVD systems. These instruments improve and simplify the analysis of samples and address specific workflows to expedite the efficacy of clinical diagnostics.