Performance Characteristics - NIPRO Diagnostics True Metrix Pro Manual

Professional monitoring blood glucose system

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Table Of Contents

Table of Contents

Introduction

The International Organization for Standardization (ISO)

develops standards in response to an identified need

in the community that will eventually be suitable for

implementation on as broad a basis as possible. ISO

developed the standard for blood glucose monitoring

performance – 15197:2003 – based on a consensus of

professionals around the world.

standard in many countries.

Standard Reference Results

± 15 mg/dL from laboratory

Less than 75 mg/dL

reference result

± 20% from laboratory

Greater than or equal to 75 mg/dL

reference result

Clinical data obtained by healthcare professionals on

the TRUE METRIX

PRO Blood Glucose Monitoring

System exceeded the minimum accuracy criteria for

ISO 15197:2003.

Accuracy:

TRUE METRIX

PRO accuracy was assessed against the

Yellow Springs Instrument. Studies were conducted at 3

clinical sites by healthcare professionals;

100% of healthcare professionals (HCP) TRUE METRIX

PRO fingertip values fell within 15 mg/dL of the YSI

results at glucose level <75 mg/dL and within 20% at

glucose levels ≥ 75 mg/dL.

Fingertip Capillary Blood < 75 mg/dL (HCP finger vs. YSI)

±5 mg/dL

26/34 = 76.5%

±10 mg/dL

32/34 = 94.1%

±15 mg/dL

34/34 = 100%

TRUE METRIX

PRO System Comprehensive Resource Guide (GDH-FAD Enzyme)