CardioChek® PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance) CardioChek PA Analyzer Accuracy and Precision Glucose Testing

PTS Diagnostics’ CardioChek ® PA Analyzer and PTS Panels ® Glucose Test Strips (Reflectance) Glucose is a sugar that is the major energy source in the body, and maintaining appropriate glucose levels is very important. This system may be used to monitor glucose. CardioChek ® test systems are simple and convenient to use. They are one of the fastest, most cost-efficient, and user-friendly methods to accurately determine glucose values. CardioChek test systems provide values and measurements using the same technology as clinical laboratories. Handheld and battery-powered, a CardioChek analyzer requires a small blood sample from a simple fingerstick. The CardioChek PA analyzer is FDA-cleared, CE-marked, internationally registered, and is CLIA-waived by the Centers for Medicare & Medicaid Services. The CardioChek family includes products for both professional and home use and is available in many global markets. Contents

Portable – use in multiple exam rooms Battery operated Only requires 15 μL of blood from finger stick Easy to use – minimal training required Reimbursable Low maintenance PTS Diagnostics’ CardioChek ® PA Analyzer and PTS Panels ® Glucose Test Strips (Reflectance)

Test results are based on readings of light reflected off a test strip that has changed colors after blood is applied. The intensity of the colors is proportional to the concentrations of glucose in the sample. The analyzer converts these reflectance photometry readings into glucose results and displays them. The enzymatic reaction that occurs is listed below. Glucose Beta-D-Glucose + O 2 glucose oxidase D-Gluco-1,5-Lactone 2H 2 O AAP + Disubstituted Aniline peroxidase Quinoneimine dye + 4H 2 O Principles of the Test

Measuring Range: PTS Panels glucose test strips (reflectance) will provide numeric results in the following range: Glucose: mg/dL ( mmol/L, g/L) If the display reads “ ___” (greater than measuring range). Measuring Range

Correlation of PTS Diagnostics’ CardioChek PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance) Relative to the Cobas® Integra 400 Plus Reference Method The linear regression data shows a strong correlation between the CardioChek PA analyzer and the reference laboratory. y = 0.89x R = 0.87 n = 192

Correlation of PTS Diagnostics’ CardioChek PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance) Relative to the Cobas® Integra 400 Plus Reference Method The linear regression data shows a strong correlation between the CardioChek PA analyzer and the reference laboratory. CardioChek PA Results Fingerstick (mg/dL) Roche Cobas ® Integra (mg/dL)

Excellent precision at the low, mid and high range of the assay. PTS Diagnostics CardioChek PA Analyzer and PTS Panels Glucose (Reflectance) Precision PTS Panels Glucose Test Strip N=50 for all levels CardioChek PA Analyzer

Glucose is linear throughout the dynamic range of each assay. PTS Diagnostics CardioChek PA Analyzer and PTS Panels Glucose (Reflectance) Linearity Glucose Concentration (mg/dL) on CardioChek PA analyzer CardioChek PA Linearity (full range)

PTS Diagnostics’ CardioChek PA analyzer with PTS Panels Glucose Test Strips (Reflectance): Is accurate relative to the Roche Cobas® Integra reference method. Exhibits a linear dynamic range. Demonstrates excellent precision at the low, mid and high ranges of the spectrum. Conclusions LIT Rev. 0 3/15