Abbott gets FDA 510(k) clearance to market glucose test FreeStyle Freedom

By Elaine Rigoli

Tampa, Fla., March 13 - Abbott Diabetes Care announced Monday that it has received 510(k) clearance from the Food and Drug Administration to market its FreeStyle Freedom blood glucose monitoring system for consumer use.

The new glucose meter requires the smallest sample size required of any blood glucose monitoring product on the market (0.3 micro liter) and provides results in just five seconds, according to a company news release.

The new meter also allows people with diabetes to test on less sensitive parts of the body such as the forearm, thigh and palm, the release said.

"To successfully manage diabetes, patients must monitor their blood glucose levels frequently," said Sherwyn L. Schwartz, MD, founder and chief executive officer of the Diabetes & Glandular Disease Clinic in San Antonio.

"In clinical trials, we found FreeStyle Freedom to be very accurate, and the small sample size and rapid test time associated with this new blood glucose meter may make testing less painful and could ultimately encourage those with diabetes to test more often," he added.

FreeStyle Freedom uses a technology exclusive to all FreeStyle meters based on coulometric measurement, according to the release.

Abbott said this patented, electrochemical technology measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size.

Diabetics worldwide use coulometric technology in more than 2 billion blood glucose tests using FreeStyle blood glucose strips, the release said.

FreeStyle Freedom will be available in April.

Abbott, based in, Alameda, Calif., is a health care company that develops pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.