A-5
Appendix A
Instructions for Use Manual Appendix A
A.6 Theory
A.6.1 Glucose
The glucose measurement is based on the following methodology:
Glucose + Enzymes(oxidized form)–––>Gluconic Acid +
Enzymes(reduced form) Equation 1
Enzymes(reduced form) + Ferricyanide––>Enzymes(oxidized
form) + Ferrocyanide Equation 2
-e
-
Ferrocyanide —————> Ferricyanide Equation 3
Electrode
The current generated at the electrode is proportional to
the glucose concentration of the sample.
A.7 Results of Multi-Center Clinical Study: Patients Requiring
Intensive Medical Intervention/Therapy
Introduction
Nova Biomedical conducted a large multi-center study of the
StatStripGlucoseHospitalMeterSystematve(5)leading
medical centers to demonstrate clinical performance within
all hospital and all professional healthcare settings on 1,698
different patients requiring intensive medical intervention. A
description of the clinical study sites is found below.
Clinical study Site #1 and Site #2 are part of the largest
tertiary hospital system in the Netherlands with 994 beds
and more than 550,000 outpatient visits, 47,000 inpatient
admissions and 51,000 outpatient care patients. The clini-
cal study was conducted by Point-of-Care (POC) personnel
within the health care settings. The clinical study data from
both sites encompasses 1,245 arterial and venous blood
glucose results (927 arterial and 318 venous) from 1,245 dif-
ferent patients. The peripheral arterial and peripheral venous
specimens were obtained from patients in medical and surgi-
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 5 9/13/18 8:29 AM
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