StatStrip® and StatStrip Xpress®2 Glucose Meters

StatStrip® and StatStrip Xpress®2 Glucose Meters
Glucose Meters

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The only glucose meters cleared by US FDA and Health Canada for use with all patients, including critically ill

 

Because of the unacceptably high rate of adverse patient events, including deaths, linked to the point-of-care (POC) use of glucose meters within hospitals, there is a recognized need for more accuracy and better performance standards for POC glucose testing in hospitals, particularly in intensive care settings.

StatStrip is designed specifically to measure and correct for clinical interferences that can be present in critically ill patients.

Proven safety and accuracy

  • In one study of over 17,300 capillary results from critically ill patients that were compared to lab results
  • In another study of 1,698 arterial and venous results from critically ill patients with over 257 medical conditions were compared to lab results
  • Improved accuracy results in less insulin misdosing and better outcomes for critically ill patients

Use of any other meter with critically ill patients is considered off label in the U.S. by the FDA and high complexity testing under CLIA

Use of any other glucose meter with critically ill patients is off label
StatStrip is FDA and Health Canada cleared and CLIA waived for use throughout all hospital and all professional healthcare settings including critical care. Use of any other glucose meter with critically ill patients is considered off-label in the U.S. by the FDA and high complexity testing under CLIA.

The personnel testing requirements for off-label use are very demanding and limit who can perform testing. In addition, a hospital must obtain patient consent to perform off-label testing.

 

The most extensively studied and proven glucose measurement technology
In addition to the studies submitted to the FDA, 168 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip. This is a statement that no other glucose meter manufacturer can make. Download a bibliography of publications here

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MA 02454-9141
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