Nipro Diagnostics’ Blood Glucose Monitoring Systems Receive FDA Clearance

Nipro Diagnostics Inc. is staying True to its roots.

The Fort Lauderdale, Fla.-based company has received U.S. Food and Drug Administration (FDA) clearance for its True Metrix Self-Monitoring and True Metrix Pro Professional Monitoring blood glucose systems.

Nipro Diagnostics conducted a clinical study in the United States for FDA submission that assessed the accuracy of both monitoring systems based field use by healthcare professionals. The clinical data indicated the two meter systems exceeded the minimum accuracy criteria for the new, more stringent ISO 15197:2013 performance requirements for accuracy, according to Nipro.

The meter, a complex algorithm, test strip chemistry and electrodes, work together as part of the True Metrix system to produce accurate results, the company said. Featuring Triple Sense technology, the systems detect, analyze and correct for environmental and physiological variability, including hematocrit and temperature, resulting in precise, proven accuracy.

The meters feature pre- and post-meal tags that enable patients to mark blood glucose results to better see how food affects blood glucose. Additionally, the products allow patients to tie notable events such as exercise, medication, sickness, as well as other occasions, to blood glucose readings in order to determine patterns and trends, resulting in better decision making for diabetes management.

An infusion of capital investment enabled Nipro Diagnostics to manufacture its new blood glucose sensor technology, though the the company declined to provide specifics about the financial support.

“With this investment, Nipro Diagnostics is building on its more than 25-year heritage of manufacturing blood glucose test strips in the United States. As we invest further in the U.S., this expansion will help us meet demand for blood glucose test strips as the number of people with diabetes is expected to continue to increase,” said Scott Verner, CEO/president of Nipro Diagnostics.

Company bigwigs said the glucose monitoring systems will be produced via a high-speed manufacturing line that uses such technologies as precision lasers that ablate electrodes on the test strips, a machine vision system that inspects over 100,000 characteristics on every test strip, and an advanced, ultra high definition communications system that allows 100 percent strip quality assurance.

True Metrix is available through retail, mail and distribution channels under partner brands or under Nipro Diagnostics’ own True brand of products.