São Paulo, Brazil — SCIEX a global leader in life science analytical technologies, announced today that a suite of medical devices has been approved by ANVISA, the Brazilian Health Regulatory Agency, for meeting the market access requirements for medical device products. Brazil’s clinical diagnostics labs face significant challenges with increasing workloads and a greater demand for rapid, accurate results. Accreditation of the devices, which include the SCIEX Triple Quad™ 4500MD LC-MS/MS, QTRAP® 4500MD LC-MS/MS, Topaz™ and Citrine® systems, will enable SCIEX to meet the needs of this market and help clinical labs to attain new quality standards in diagnostic testing.
The Citrine and 4500MD systems are flexible LC-MS/MS systems offering exceptional sensitivity and fast data acquisition, allowing clinical customers to obtain reliable results quickly. The exclusive QTRAP® technology enables unique workflows, providing quantitative and qualitative analysis in a single injection, and allowing the use of highly selective MRM3 quantitation to eliminate interferences. The Citrine System is specifically designed to meet the unique needs of clinical labs that require the greatest sensitivity, the highest throughput, a wide dynamic range, and the ability to employ simplified sample preparation.
The Topaz System is a fully integrated LC-MS/MS system for clinical diagnostics that lowers the barriers to adoption of mass spectrometry, making it accessible to all staff in clinical labs. The system is driven by ClearCore™ MD Software that simplifies and streamlines both workflows and method development, while incorporating features that enhance usability to help new users build proficiency quickly.
“We are very pleased to share this news with our customers and with the industry. We know that the routine diagnostic testing lab requires accurate trace level quantitation of multiple compounds in human specimens,” said Aaron Hudson, Vice President and GM, Global Marketing and SCIEX Diagnostics. “SCIEX clinical offerings are truly reliable systems that can help meet clinical lab objectives by saving time, cutting costs, and supporting physicians with greater confidence in their results.”
All of these systems are designed to maximize uptime in clinical laboratories and support continuous high-throughput operations. They each feature the industry leading SCIEX Turbo V™ Source and Curtain Gas™ interface for outstanding reliability, sensitivity, and reproducibility in routine clinical testing. These systems provide scientists with the ability to perform multiple assays and quantitate multiple compounds in a single run, resulting in fewer tests, shorter runtimes, and significant cost savings for Brazil’s clinical laboratories.
In addition, the Jasper® LC System, an FDA Class I and CE-marked in vitro diagnostic HPLC system that can operate at high flow rates and high pressures, supports a wide range of applications. Designed for use with SCIEX IVD mass spectrometers, the Jasper HPLC system brings the proven performance and reliability of a SCIEX LC-MS/MS solution to your clinical laboratory.
“It is a tremendous gain for SCIEX to launch our first healthcare-registered products in Brazil,” said Mateus Campos, Director of Sales, Service and Support for Brazil. “We are proud that the reach and analytical depth of such technologies are now available to a major and growing healthcare market. We believe that this approval by ANVISA will lead us to a new era in Brazil’s clinical in vitro diagnostic field.”