FDA 510(k) Clearance for VIDAS® 3 - the New Generation of VIDAS®
bioMérieux's VIDAS® 3, the new generation of VIDAS® has received FDA 510(k) clearance. This instrument, which further enriches the offering of the VIDAS® immunoassay product range, VIDAS® and mini VIDAS®, is now commercially available in the United States. VIDAS® 3 is CE marked and registered at the Chinese Food and Drug Administration (CFDA) which makes it available to clinical labs on a global scale.
VIDAS® 3 features enhanced automation, in particular the pre-analytical section from the barcoded primary tube including dilution, improved traceability and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Designed with the help of 1,500 immunoassay laboratories, this new-generation instrument has received an enthusiastic reception by laboratory professionals.
“The VIDAS® 3 analyzer, proved to be a very easy instrument to use with automation, sample handling and intuitive software. Having worked on a study with this analyzer, I have no doubt that the VIDAS® 3 will improve walkaway time and our lab workflow,” said Wendy Skinner BS MT(ASCP), Lead Technologist, BayCare Medical, New Port Richey, FL.
VIDAS® 3 reinforces the ease of use that has made the VIDAS® range so popular. This low throughput immunoassays platform can perform tests on demand, individually or in series, 24 hours a day and seven days a week. As a result, it is perfectly suited to centralized as well as satellite laboratories, bringing both versatility and reliability to healthcare professionals who are able to optimize their workflows and guarantee the quality of biological testing.
VIDAS® 3 uses the same reagents as the other instruments in the VIDAS® range. At launch in the U.S., VIDAS® 3 menu features specialty and high medical value tests, such as VIDAS® B·R·A·H·M·S PCT™ for the management of septic patients.1 The single test concept and new features make the VIDAS® 3 particularly well adapted to meet the needs of labs supporting Emergency Departments and Critical Care.
1. VIDAS® B.R.A.H.M.S PCT™ in the U.S. is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission, for progression to severe sepsis and septic shock
2. CAP Today, July 2015
Date Published: 26th August 2015
Source article link: bioMérieux (Clinical Diagnostics)
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