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Appendix A
Instructions for Use Manual Appendix A
A.8 Results of Multi-Center Capillary Critical Care Study:
Patients Requiring Intensive Medical Intervention/Therapy
Introduction
Nova Biomedical conducted a large multi-center study of
the StatStrip Glucose Hospital Meter at 3 leading medical
centers to demonstrate the clinical performance of capillary
wholebloodspecimensobtainedbyngerstickwithincritical
care hospital settings on patients receiving intensive medi-
cal intervention/therapy. Clinical Study Site #1 was a CLIA
Waived prospective study and the other 2 studies conducted
in Site #2 and Site #3 were CLIA Waived retrospective
studies designed to assess real world clinical performance.
Study Site #1 and #3 is one of the top ranked hospitals in
Diabetes & Endocrinology located in Rochester, MN and
Study Site #2 is one the world’s preeminent healthcare
institutions located in Maryland. A description of the clinical
study is found below.
A.8.1 Prospective Clinical Study
The prospective critical care clinical study (Site #1) included
568 enrolled critical care patients undergoing treatment
within 3 critical care departments (CVICU, MICU and
OR). The critical care patients from the CVICU and MICU
included 80 unique patient conditions receiving a total of
3,785 medications representing 17 parent drug classes.
Medical conditions and medications were unavailable for
critical care patients in the OR.
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 35 9/13/18 8:29 AM
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