Santa Clara, CA, March 31, 2009 – MEC Dynamics Corp (MEC) today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new point-of-care (PoC) test, the Avie™ A1c, for the quantitative measurement of HbA1c in diabetic patients. MEC’s Avie™ A1c is the first in its range of rapid PoC tests that will use its patented platform to offer high performance and affordable diagnostics for the physician’s office as well as home testing. Avie™ A1c has many features designed to deliver quick and accurate results for HbA1c. Using blood from a finger prick and a single use disposable cartridge, HbA1c results are displayed on the screen of the handheld reader within 3 minutes. The Avie™ A1c is NGSP certified for accuracy. Features of MEC’s Avie™ A1c include:
• 3 minute HbA1c test with blood from finger prick
• No sample preparation, venesection or centrifugation
• Low cost handheld colorimetric reader with screen
• Connectivity to ancillary printer
• Inexpensive and accurate measurement
• Electronically coded cartridges
• Convenient for home or clinic use
• Optional customizable data management software
Key facets of the Avie™ A1c system are its ease of use, its low cost compact reader as well as its software that allows for accurate and quick results.
“As the trend towards diagnostics taking place in the physician’s office and in the home accelerates, MEC’s first FDA approved point-of-care product, Avie™ A1c, offers a simple, affordable and accurate device for the monitoring of patients with diabetes” said Manny Mpock, CEO, MEC Dynamics Corp.
About MEC’s Platform Technology
MEC has developed a patented innovative micro-fluidics point-of-care platform capable of performing a range of enzymatic as well as immunoassays.
Other tests in development include Prothrombin Time (PT/INR), Lipid and Liver Panels.
About MEC Dynamics
MEC is a medical devices company developing and manufacturing point-of-care diagnostic products, using its proprietary technology.
MEC’s devices have been designed for use in the both physician’s office as well as the patient’s home. They enable the ‘real time’ measurement of key blood analytes for early detection and more effective management of a variety of diseases including diabetes, cardiovascular diseases and cancer.
Chronic and life-threatening diseases occurring in both industrial and developing countries could be better treated through early detection and monitoring. MEC aims to be a global developer and manufacturer of point-of-care diagnostic products using its technology platform.
MEC’s news releases and other information are available on the company’s web site at www.mecdynamics.com.
