Technology | October 03, 2013

Beckman Coulter Receives FDA Clearance of AccuTnI+3 Troponin I Assay on UniCel DxI Immunoassay Systems

Cardiac Disease Management Assay Available on Entire Immunoassay Portfolio

blood testing cath lab beckman coulter danaher

October 3, 2013 — Delivering the precision, clinical sensitivity and clinical specificity necessary to assist physicians with the diagnosis of myocardial infarction (MI), Beckman Coulter Inc. announced the U.S. Food and Drug Administration (FDA) clearance of its new Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay systems.

Following the June 2013 clearance of the Access AccuTnI+3 troponin I assay on Beckman Coulter's Access 2 immunoassay analyzer, the new troponin assay is now cleared for use on all of the company's immunoassay systems, as well as the UniCel DxC integrated chemistry and immunoassay series.

"The AccuTnI+3 troponin assay has been clinically proven through a large multi-center study that enrolled more than 1,900 subjects, and it is confirmed that the test provides the clinical performance needed for optimal patient management," said Arnd Kaldowski, president, Beckman Coulter Diagnostics. "Our new troponin I assay is directly aligned with the FDA's October 2010 guidance to manufacturers of troponin assays and confirms our commitment to modernize the performance evaluation of this critical test."

AccuTnI+3 delivers clinical sensitivity and specificity aligned with contemporary use of troponin set forth by the FDA and utilizes platform-specific reagents and calibrators.

For more information: www.beckmancoulter.com, www.danaher.com

Related Content

Abbott Point-of-Care Blood Test Speeds Heart Attack Diagnosis
News | Blood Testing | October 26, 2018
For someone experiencing cardiac symptoms in the emergency room, every minute matters as physicians determine whether...
New Noninvasive Blood Glucose Test as Effective as Finger Prick

Image courtesy of University of Missouri School of Medicine

News | Blood Testing | October 24, 2018
For those living with diabetes, monitoring blood glucose accurately is necessary to prevent diabetes-related...
Abbott Receives CE Mark for High Sensitive Troponin-I Test
News | Blood Testing | October 16, 2018
October 16, 2018 — Abbott announced that its High Sensitive Troponin-I...
AI-Driven Blood Test Accurately Diagnoses Peripheral Artery Disease in Diabetic Patient
News | Blood Testing | September 04, 2018
Prevencio Inc. announced new data demonstrating its HART PAD test accurately diagnoses peripheral artery disease (PAD)...
More Sensitive Blood Test Diagnoses Heart Attacks Faster
News | Blood Testing | August 06, 2018
August 6, 2018 — A new test to assess a whether or not someone is having a...
Singulex cTnl Assay Can Identify Presence, Severity of CAD in Stable, Symptomatic Outpatients
News | Blood Testing | March 26, 2018
March 26, 2018 — Measurement of cardiac troponin in stable patients with chest pain using the ultra-sensitive Singule
Florida Medical Center First in State to Offer High Sensitive STAT Blood Test
News | Blood Testing | September 07, 2017
In July, The Heart Institute at Florida Medical Center became the first hospital in the state of Florida to offer the U...
Patients With Low Corus CAD Test Score Less Likely to Undergo Cardiac Referra
News | Blood Testing | May 02, 2017
CardioDx Inc. recently announced the publication of results from the multi-center, community-based PRESET Registry in...
New Blood Test Predicts Major Cardiac Events Better Than Clinical Evaluation of Other Common Risk Factors
News | Blood Testing | April 28, 2017
Prevencio Inc. announced the publication of data demonstrating that a simple new blood test is more accurate than...
New Study Pursues Universal Sample Bank for Troponin Tests
News | Blood Testing | April 13, 2017
April 13, 2017 — A study published recently in the American Association for Clinical Chemistry’s (AACC)...
Overlay Init