Abbott’s Cross-Contamination Reducing FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring System Receives FDA Clearance

Abbott today announced that it has received U.S. Food and Drug Administration (FDA) clearance for its FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring SystemTM, an advanced blood glucose monitoring system designed to address the key needs of hospital customers: high accuracy, efficient operation, dual-band wireless access to immediate test results, and helps in the reduction of the risk of test strip cross-contamination.

"The FreeStyle Precision Pro system represents a significant step forward as we work to provide tools to improve the way hospitals manage patients' glucose levels," said Heather L. Mason, senior vice president, Diabetes Care, Abbott. "It makes the data available in real time, thanks to the meter's new wireless capabilities. With its individually foil-wrapped test strips, the system is also designed to help reduce test strip cross-contamination in hospital environments."

Key features of Abbott's FreeStyle Precision Pro system include:

Addresses Hospital Needs for Cross-Contamination Control
• Abbott's FreeStyle Precision Pro system is the only inpatient blood glucose monitoring system among leading hospital brands to use individually foil-wrapped test strips,¹ helping reduce the risk of test strip cross-contamination of blood and bacteria.² This Abbott exclusive advantage helps hospitals comply with the Centers for Disease Control and Prevention regarding protection of unused supplies.³
• The device conforms to FDA requirements for cleaning and disinfection, which require devices to be disinfected after each use. The FreeStyle Precision Pro Meter also offers a replaceable strip port that can be removed for replacement on-site.

Dual-Band Wireless Connectivity Enables Real-Time Access to Test Results and Improves Staff Workflow
• Abbott's FreeStyle Precision Pro system allows for real-time, dual-band wireless communication between the handheld meter at the patient bedside and the hospital information system, giving clinical staff immediate access to patient test results throughout their facility. The dual-band wireless technology enables the flexibility of wireless access within a hospital's Wi-Fi-enabled network when properly configured. The system is designed so that clinical operators need not interrupt their busy workflow to conduct routine docking or attach a data cable to download patient results, saving time while also providing access to real-time data. This helps ensure immediate access to test results through the hospital's electronic medical record system, and to facilitate clinical decision whenever it is needed.

Designed with Higher Performance Characteristics
• The FreeStyle Precision Pro system features a new algorithm to correct for hematocrit interference. The test process occurs in five seconds for prompt and accurate delivery of test results.

2D Barcode Technology for Patient Identification
• The new system adds technology to read newer 2D barcodes, which are becoming more prevalent in healthcare identification systems. This technology enhances the accuracy of patient identification with TrueIDTM technology.

1. As of July 2013 among leading hospital brands of blood glucose test strips in the U.S. (LifeScan, Roche, and Nova Biomedical)
2. Data on file at Microbe Inotech Laboratories, Inc., St. Louis, MO., Report MILB-8486A, March 2012
3. Diabetes and Viral Hepatitis: Important Information on Glucose Monitoring, Centers for Disease Control: http://www.cdc.gov/hepatitis/Settings/GlucoseMonitoring.htm