Ortho Clinical Diagnostics Receives FDA 510(k) Clearance for VITROS® Chemistry Products HbA1c Reagent Kit, an Enhanced Diabetes Testing Assay

Ortho Clinical Diagnostics Receives FDA 510(k) Clearance for VITROS® Chemistry Products HbA1c Reagent Kit, an Enhanced Diabetes Testing Assay

Jun 18, 2015

Raritan, NJ, June 18, 2015 – Ortho-Clinical Diagnostics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the VITROS® Chemistry Products HbA1c Reagent Kit to be used on the VITROS® 5600 Integrated System, VITROS® 4600 Chemistry System, and the VITROS® 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in the diagnosis of diabetes, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.


The VITROS® Chemistry Products HbA1c Reagent Kit offers operational and performance enhancements over the company’s currently marketed VITROS® Chemistry Products d%A1c Reagent Kit, including higher throughput and simplified calibration. The design of the VITROS® HbA1c assay allows its use in patients with hemoglobin variants S, C, D, and E traits. The new assay is now available and will replace the VITROS® Chemistry Products d%A1c Reagent Kit, which will eventually be discontinued.


“The VITROS® Chemistry Products HbA1c assay was developed for improved accuracy to meet the recently tightened National Glycohemoglobin Standardization Program (NGSP) certification requirements, as well as to meet the evolving needs of today’s laboratory professionals for enhanced products,” said Ted DiMagno, PhD, Principal Scientist, Research and Development who led the development team for the test at Ortho Clinical Diagnostics. “This easier-to-use and faster new assay will enable our customers to more effectively, productively and confidently diagnose and monitor diabetes as the rate of the disease continues to climb in U.S., without having common hemoglobin variants interfere with results.”


A false high or low HbA1c value caused by a clinically silent hemoglobin variant may lead to over or under treatment.1 The design of the VITROS® HbA1c assay allows its use in patients with hemoglobin variants S, C, D and E traits. In addition, the method is unaffected by the presence of chemically modified hemoglobin.2 Approximately 7 percent of the world's population are heterozygous carriers of hemoglobinopathies. Among diabetic patients, more than 12 million worldwide are estimated to have a hemoglobin disorder.3  In the U.S., the four most common variants are Hb S, C, E, and D. HbE is found primarily in people from Southeast Asia and is now encountered quite commonly in the U.S. HbD Punjab is found most commonly in the Punjab region of India and is also encountered in the U.S.3


The percent of glycated hemoglobin (HbA1c) in a person’s blood is the worldwide standard for measuring blood glucose levels to detect and monitor long-term glucose control in individuals with diabetes. The American Diabetes Association now recommends the use of the A1c test to detect and monitor diabetes based on an extensive International Expert Committee review of established and emerging epidemiological evidence.4 According to the 2014 National Diabetes Statistics report, 29.1 million Americans had diabetes in 2012, with more than 8 million of them undiagnosed. Diabetes remains the seventh leading cause of death in the United States, directly responsible or contributing to more than 234,000 deaths in 2010. People with diabetes are also at high risk for blindness, kidney failure, heart disease, stroke and amputations.5


The VITROS® Chemistry Products HbA1c Reagent Kit uses VITROS® MicroTip Technology, which offers a special chemistry menu and user-defined assays in a cost-effective, easily implemented format. It utilizes single-use disposable tips and closed reagent packs to eliminate the risk of sample carryover or reagent-to-reagent contamination, and to extend on-board reagent stability. Similar to VITROS® MicroSlide and MicroWell Technologies, this test is performed without the need for water.


About VITROS® Systems

Ortho Clinical Diagnostics pioneered the VITROS® series of laboratory systems in 1978 and continues to expand and evolve them to reduce the probability of human error, improve operational efficiencies and increase uptime in clinical labs. The VITROS® series of systems includes automated, integrated and compact analyzers that operate with standardized reagents and results across all platforms. The introduction of the exclusive VITROS® MicroSlide Technology revolutionized chemistry and immunoassay testing by offering the first and only dry slide technology, eliminating the need for a water supply. VITROS® MicroSlide Technology is one of the five VITROS® enabling technologies, which also include VITROS® MicroTip Technology, VITROS® MicroWell Technology, VITROS®MicroSensor Technology and VITROS® Intellicheck® Technology. These technologies power the transformational performance in labs around the world by delivering confidence in results, productivity and financial predictability as well as environmental benefits.


In addition, Ortho Clinical Diagnostics’ broad menu of more than 125 VITROS® assays offers all of the most important clinical chemistry tests, covering major disease states including cardiac disease, cancer, reproductive endocrine disease, infectious disease, thyroid disease, metabolic conditions and anemia.


About Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. delivers high-quality in vitro diagnostic products that give healthcare professionals around the world the information needed for making diagnosis and treatment decisions. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com.


The VITROS® Chemistry Products HbA1c Reagent Kit, VITROS® 5,1 FS, VITROS® 4600, VITROS® 5600, VITROS® MicroSlide, VITROS® MicroTip, VITROS® MicroWell, VITROS® MicroSensor, VITROS® Intellicheck® and the VITROS® logo are trademarks of Ortho-Clinical Diagnostics, Inc.




1 Nasir N, et al. Hemoglobin variants detected by hemoglobin A1c analysis and the effects on HbA1c measurements.  2010 Int J diabetes Dev Ctries. 2010 Apr-Jun; 30 (2): 86-90.  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2878696/


2 VITROS® Chemistry Products HbA1c Reagent Kit Instructions for Use.


3 Little RR and Roberts, WL. A review of variant hemoglobins interfering with hemoglobin A1c measurement. J Diabetes Sci Technol, 2009, 3:446


4 American Diabetes Association. Diagnosis and classification of diabetes mellitus.  Diabetes Care 2014 (January); 37 (S1): S81-S90.


5 American Diabetes Association.  Statistics about diabetes.  Available at: http://www.diabetes.org/diabetes-basics/statistics/.