Click here to close now.

SYS-CON MEDIA Authors: Dana Gardner, Elizabeth White, Carmen Gonzalez, PagerDuty Blog, Liz McMillan

News Feed Item

Beckman Coulter Announces FDA Clearance of New Access AccuTnI+3 Troponin I Assay for the Access 2 Immunoassay System

Delivering Diagnostic Confidence in Cardiac Disease Management

BREA, Calif., June 19, 2013 /PRNewswire/ -- Continuing its long history of proven clinical performance in diagnosis of myocardial infarction (MI), Beckman Coulter, Inc. announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system.

"Clinicians have depended on Beckman Coulter's troponin I test for over 12 years and the new AccuTnI+3 assay has the proven performance to continue providing dependability to laboratories supporting emergency care," said Arnd Kaldowski, president, Beckman Coulter Diagnostics. "Our new troponin I assay offers emergency physicians confidence in results that enable them to provide excellent care for patients at risk of MI."

In October 2010, the FDA issued guidance to all manufacturers of troponin assays in an effort to modernize the performance evaluation and regulatory review of these critical tests. As such, the FDA requested that manufacturers conduct a clinical study in order to "modernize the labeling and claims in order to ensure that laboratories and clinicians are informed of the true performance of troponin assays to help in result interpretation and laboratory verification of performance parameters."

In accordance with the FDA's new requirements, Beckman Coulter conducted a large multicenter prospective clinical trial on the AccuTnI+3 troponin I assay trial that enrolled over 1,900 subjects, and confirmed that the assay provides the clinical performance needed for optimal patient management. The data from this trial shows that the assay delivers the precision, clinical sensitivity and clinical specificity necessary to assist physicians with the diagnosis of MI.

About Beckman Coulter
Beckman Coulter, Inc., based in Orange County, Calif., a subsidiary of Danaher Corporation (NYSE:DHR), develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents. For more than 75 years, our products have been making a difference in peoples' lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care. For more information, visit www.beckmancoulter.com.

Beckman Coulter, the stylized logo, Access and AccuTnI are registered trademarks of Beckman Coulter, Inc.

About Danaher
Danaher Corporation is a science and technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers. Our premier brands are among the most highly recognized in each of the markets we serve. The Danaher Business System provides a foundation to our 63,000 associates around the world, serving customers in more than 125 countries. In 2012, we generated $18.3 billion of revenue. For more information please visit our website: www.danaher.com.

Statements in this release that are not strictly historical, including any statements regarding events or developments that we believe or anticipate will or may occur in the future, are "forward-looking" statements within the meaning of the federal securities laws. There are a number of important factors that could cause actual results, developments and business decisions to differ materially from those suggested or indicated by such forward-looking statements, including those set forth in Danaher's SEC filings, including Danaher's 2012 Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the first quarter of 2013.  You should not place undue reliance on any such forward-looking statements.  These forward-looking statements speak only as of the date of this release and Danaher does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise. 

SOURCE Beckman Coulter

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes ...
Are your applications getting in the way of your business strategy? It’s time to rethink your IT approach. In his session at 16th Cloud Expo, Madhukar Kumar, Vice President, Product Management at Liaison Technologies, will discuss a new data-centric approach to IT that allows your data, not applications, to inform business strategy. By moving away from an application-centric IT model where data integration and analysis are subservient to the constraints of applications, your organization will b...
SYS-CON Events announced today that Liaison Technologies, a leading provider of data management and integration cloud services and solutions, has been named "Silver Sponsor" of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York, NY. Liaison Technologies is a recognized market leader in providing cloud-enabled data integration and data management solutions to break down complex information barriers, enabling enterprises to make sm...
What’s inside the cloud? Hard work. Cloud operators know the world inside the datacenter is gritty. Vendor marketing speak and cloudwashing quickly melt in the heat of SLAs, uptime guarantees, and users who want it now. In his session at DevOps Summit, Hernan Alvarez, Chief Product Officer at Blue Box Group, will deliver an unvarnished look inside the world of cloud operators, from the perspective of someone who lives it. Attendees get a front-row look into the toolkits and processes that enabl...
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY., and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MangoApps provides private all-in-one social intranets allowing workers to securely collaborate from anywhere in the world and from any device. Social, mobile, and eas...
WSM International has launched a DevOps services division that offers assessment, consulting and implementation to large enterprises and organizations with complex infrastructures. The concept of DevOps is to blend information technology (IT) software development with operations to optimize the computing infrastructure according to the specific needs of the organization. According to a recent press release from Gartner, "By 2016, DevOps will evolve from a niche strategy employed by large cloud ...
SYS-CON Events announced today that Solgenia will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Solgenia is the global market leader in Cloud Collaboration and Cloud Infrastructure software solutions. Designed to “Bridge the Gap” between Personal and Professional S...
SYS-CON Events announced today that QTS Realty Trust, one of the nation’s largest and fastest-growing providers of data center facilities and cloud services and a leader in security and compliance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. QTS Realty Trust, Inc. (NYSE: QTS) is a leading national provider of data center solutions and fully managed services, and a leader in security and compliance...
SYS-CON Events announced today that WSM International (WSM), the world’s leading cloud and server migration services provider, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. WSM is a solutions integrator with a core focus on cloud and server migration, transformation and DevOps services.
Sematext is a globally distributed organization that builds innovative Cloud and On Premises solutions for performance monitoring, alerting and anomaly detection (SPM), log management and analytics (Logsene), and search analytics (SSA). We also provide Search and Big Data consulting services and offer 24/7 production support for Solr and Elasticsearch.
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, will explain the best practices of continuous testing at high scale, which is r...
Modern Systems announced completion of a successful project with its new Rapid Program Modernization (eavRPMa"c) software. The eavRPMa"c technology architecturally transforms legacy applications, enabling faster feature development and reducing time-to-market for critical software updates. Working with Modern Systems, the University of California at Santa Barbara (UCSB) leveraged eavRPMa"c to transform its Student Information System from Software AG's Natural syntax to a modern application lev...
Cloud is not a commodity. And no matter what you call it, computing doesn’t come out of the sky. It comes from physical hardware inside brick and mortar facilities connected by hundreds of miles of networking cable. And no two clouds are built the same way. SoftLayer gives you the highest performing cloud infrastructure available. One platform that takes data centers around the world that are full of the widest range of cloud computing options, and then integrates and automates everything. J...
The WebRTC Summit 2014 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
SYS-CON Events announced today Sematext Group, Inc., a Brooklyn-based Performance Monitoring and Log Management solution provider, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Sematext is a globally distributed organization that builds innovative Cloud and On Premises solutions for performance monitoring, alerting and anomaly detection (SPM), log management and analytics (Logsene), search analytics (S...