A-7
Appendix A
Instructions for Use Manual Appendix A
were collected from 73 different patients and are from the
types of patients that one would see in oncology and renal
healthcare settings.
StatStrip performance versus the laboratory methods was
evaluated by paired specimen analyses (arterial and venous
whole blood versus plasma) from patients within various
clinical settings. The clinical studies included patients
throughout all hospital settings involving 19 primary medi-
cal condition categories with 257 different medical condi-
tion sub-categories. The clinical study patients received
approximately 8,000 medications representing 33 parent
drug classes and 144 medication sub-classes. The patient
populations investigated represent a highly diverse spectrum
of severity of illness (acuity). The effect of confounding fac-
tors such as PO
2
(ventilation), pH, hematocrit, medications,
endogenous substances, acuity of illness, and specimen
types were given special consideration within these clinical
settings and were analyzed along with study results.
In addition to the medical condition for each clinical study pa-
tient, when available, the following information was obtained:
• Specimen type: (Arterial or Venous only)
• Collection site: (Central or Peripheral draw site)
• Patient Demographic Information: (Male or Female,
Date of Birth)
• Measured Whole Blood Glucose: StatStrip Glucose
Hospital Meter System
• Measured Plasma Glucose: Central laboratory
method
• Hospital Wards/Divisions: ICU, ED, OR, etc.
• Diagnosis or Medical Condition: Reason for Hospital
stay
• Drugs and Other Substances: Listing of all drugs
and other endogenous substances for patient on
day of clinical study testing
• Measured Hematocrit: Central laboratory method
• Measured Chemistries: Central laboratory method
• Oxygenation Status: Arterial blood gas results for
patient, if available on day of testing
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 7 9/13/18 8:29 AM
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