Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

Abbott Announces CE Mark for ARCHITECT Clinical Chemistry HbA1c Test

Published: Monday, May 13, 2013
Last Updated: Monday, May 13, 2013
Bookmark and Share
CE marking for test to aid doctors with diagnosing and monitoring diabetes.

Abbott has announced CE Marking (Conformité Européenne) for the ARCHITECT clinical chemistry Hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes.

As of 2012, more than 371 million people worldwide were living with diabetes and half of the people with diabetes remained undiagnosed.

If left undiagnosed or not properly managed, diabetes can cause serious health complications.

The HbA1c test is a blood test that reflects a person's average blood glucose levels over the past three months. In 2009, an international expert committee recommended that physicians may use an HbA1c test for the diagnosis of type 2 diabetes and identification of patients at risk for developing diabetes if the assay meets specific performance criteria, such as certification and standardization processes outlined by the National Glycohemoglobin Standardization Program (NGSP) and the International Federation of Clinical Chemistry (IFCC).

"The new ARCHITECT clinical chemistry Hemoglobin A1c test provides physicians with important information that may help patients take critical steps to manage the progression of this very serious disease," said Christian Fischer, senior medical director, Diagnostics Products, Abbott.

Diabetes can be managed by using diabetes medicines, making important lifestyle changes related to diet and exercise, and monitoring blood glucose and HbA1c levels.

For people whose HbA1c test results are normal, doctors may recommend that testing be repeated at least every three years or more frequently depending on a person's initial results and risk status.

"When diabetes is not managed properly, it can lead to damage of important systems in the body, including the heart, kidneys, and eyes, and even cause life-threatening complications," said Brian Blaser, executive vice president, Diagnostics Products, Abbott.

Blaser continued, "With the CE Mark of Abbott's ARCHITECT clinical chemistry HbA1c test, we are pleased to offer this valuable tool to help doctors diagnose diabetes and identify patients at-risk for developing diabetes. Doctors can use this information to improve patient care."

The ARCHITECT clinical chemistry HbA1c test is available in several countries throughout Europe, Asia, Latin America, Canada and Africa, pending country registration.

Abbott recently filed for 510(k) clearance with the U.S. Food and Drug Administration.

Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More Than 5,200+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Abbott to Acquire Alere for $5B
Acquisition broadens Abbott's diagnostics footprint by providing access to new product applications, channels and geographies.
Monday, February 01, 2016
Scientific News
Unravelling the Role of Key Genes and DNA Methylation in Blood Cell Malignancies
Researchers from the University of Nebraska Medical Center have demonstrated the role of Dnmt3a in safeguarding normal haematopoiesis.
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Editing Gene Mutations in Anemia
Researchers successfully use a new gene editing strategy to correct mutations that cause a form of anemia.
Genes Help Track Odd Migrations of Zika Mosquitoes
Study shows that mosquitoes carrying Zika virus or Dengue fever a genetically distinct around the world.
Nanomedicine Aims to Improve HIV Drug Therapies
New research aims to improve the administration and availability of drug therapies to HIV patients using nanotechnology.
Tumor Markers Reveal Lethality Of Bladder Cancers
Researchers found that detection of certain tumor cells in early stage cancers helps identify high-risk cancers.
Gene Editing Corrects Sickle Cell Mutation
Researchers demonstrate a potential pathway to developing gene-editing treatments for sickle cell disease.
Driving Mosquito Evolution to Fight Malaria
Researchers propose insect repellent in conjunction with insecticides to extend current insecticide lifetime.
Lab-on-a-Chip to Help Detect Cancer
In this podcast, we speak to Gustavo Stolovitsky to learn about his career and the work he is doing at IBM Research.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos