System accuracy evaluation of FORA Test N Go Blood Glucose Monitoring System versus YSI 2300 STAT Plus glucose analyzer following ISO 15197: PDF Free Download

System Accuracy Evaluation of Project number: Fora092614-01 System accuracy evaluation of Blood Glucose Monitoring System versus YSI 2300 STAT Plus glucose analyzer following ISO 15197:2013 Date: 13 th October 2014 20 th October 2014 1/21

System Accuracy Evaluation of Table of contents Abstract... 3 Responsible Parties & Signatures... 4 1. Introduction... 5 2. Material and Methods... 6 2.1. Recruitment of test subjects... 6 2.2. Blood glucose monitoring system (BGMS)... 6 2.3. Reference standard... 7 2.4. Preparation of test samples... 7 2.5. Test of blood glucose... 8 2.6. Statistics... 8 3. Results... 9 3.1. Ratio of test subjects... 9 3.2. Test results... 10 3.2.1. Accuracy results following ISO 15197:2013 (E)... 10 3.2.2. Accuracy results following ISO 15197:2003... 12 3.2.3. Statistical analysis... 15 3.2.4. Absolute differences between and YSI 2300 STAT PLUS... 17 4. Conclusion and Discussion... 18 References... 18 Appendix... 19 2/21

System Accuracy Evaluation of Abstract Objective: The goal of the study was to assess the accuracy and reliability of Fora blood glucose monitoring system (BGMS) in the clinical studies according to the international standard ISO 15197: 2013(E) criteria and more stringent guidelines. Methods: The study sample was collected from 108 subjects comprised 53 patients with types 1 diabetes and 36 patients with types 2 diabetes, and 19 people with type unknown. The capillary blood specimens was collected via fingertip stick from participants at AMCR Institute (700 West El Norte Parkway, Suite 201, Escondido, CA 92026) and tested on three different lots of test strips. Results: The Fora BGMS met the requirements of ISO 15197:2013 from all three lots of test strips tested. Reagent system lot Within ± 5 mg/dl & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) Within ± 10 mg/dl & ± 10 % (Within ± 0.56 mmol/l & ± 10 %) Within ± 15 mg/dl & ± 15 % (Within ± 0.83 mmol/l & ± 15 %) TD14D228-C0E 144 / 200 (72.0 %) 192 / 200 (96.0 %) 197 / 200 (98.5 %) TD14D828-C0E 142 / 200 (71.0 %) 195 / 200 (97.5 %) 197 / 200 (98.5 %) TD14D928-C0E 139 / 200 (69.5 %) 192 / 200 (96.0 %) 198 / 200 (99.0 %) This BGMS is also compliant with the requirements of DIN EN ISO 15197:2003 with all 3 reagent system lot(s). Reagent system lot Within ± 5 mg/dl & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) Within ± 10 mg/dl & ± 10 % (Within ± 0.56 mmol/l & ± 10 %) Within ± 10 mg/dl & ± 15 % (Within ± 0.56 mmol/l & ± 15 %) Within ± 15 mg/dl & ± 20 % (Within ± 0.83 mmol/l & ± 20 %) TD14D228-C0E 117 / 200 (58.5 %) 178 / 200 (89.0 %) 196 / 200 (98.0 %) 199 / 200 (99.5 %) TD14D828-C0E 107 / 200 (53.5 %) 169 / 200 (84.5 %) 197 / 200 (98.5 %) 199 / 200 (99.5 %) TD14D928-C0E 112 / 200 (56.0 %) 171 / 200 (85.5 %) 194 / 200 (97.0 %) 200 / 200 (100 %) Conclusion: The study suggest that the Fora blood glucose monitoring system not only met the current accuracy standard (ISO15197:2003), but also met with the minimum acceptable accuracy standard published in the newer 2013 guideline (ISO15197:2013) when compared the test results with a laboratory reference. 3/21

System Accuracy Evaluation of 1. Introduction Diabetes is a chronic illness that requires continuing medical care and ongoing patient self-management education and support to prevent acute complications and to reduce the risk of long-term complications. It is predicted that the total number of people with diabetes will rise from 171 million in 2000 to 366 million in 2030 1. Clinical evidence has clearly indicated that improved metabolic control leads to a significant reduction in microvascular complications associated with diabetes. Self-monitoring blood glucose system (SMBG) has become an important and efficacy tool in the daily blood glucose management for people with diabetes. Optimal utilization of SMBG can lead to improvements in glycemic control by providing patients with immediate feedback on the impact of food, exercise, or medication on their blood sugar. Therefore, simple-to-use and accurate performance will be the conditions needed in a good glucose meter. The Fora Blood Glucose monitoring system for this study provides a faster and more effective way of blood glucose measurement. Furthermore, these glucose meters employ good technology which can eliminate miscoding errors that could lead to inaccurate results. Features of self-monitoring blood glucose system (SMBG) include ease-of-use, capillary action, electrodes with carbon, and biosensor technology. This study was to evaluate the system accuracy following ISO 15197:2003 2 protocol and if possible, the newly published ISO 19197:2013 3 guideline. EN ISO 15197:2003 is an international standard published by International Standard Origination (ISO) specifying requirements for in vitro glucose monitoring systems on self-testing in managing diabetes mellitus. The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: Ninety-five percent (95 %) of the individual glucose results shall fall within ± 15 mg/dl (± 0.83 mmol/l) of the results of the reference measurement at glucose concentrations < 75 mg/dl (< 4.2 mmol/l) and within ± 20 % at glucose concentrations 75 mg/dl ( 4.2 mmol/l). In 2013, ISO has published a newer standard ISO 15197:2013 (E) which tightens the accuracy acceptance criteria. The minimum acceptable accuracy for results produced by a glucose monitoring system has been changed to the followings: Ninety-five percent (95 %) of the individual glucose results shall fall within ± 15 mg/dl (± 0.83 mmol/l) of the results of the reference measurement at glucose concentrations < 100 mg/dl (< 5.55 mmol/l) and within ± 15 % at glucose concentrations 100 mg/dl ( 5.55 mmol/l). Comparison between 2 ISO standards: EN ISO 15197: 2003 ISO 15197: 2013 (E) Maximum deviation from glucose reference value At glucose levels < 75 mg/dl (< 4.2 mmol/l) At glucose levels 75 mg/dl ( 4.2 mmol/l) ± 15mg/dl (0.83 mmol/l) ± 20% At glucose levels < 100 mg/dl (< 5.5 mmol/l) At glucose levels 100 mg/dl ( 4.2 mmol/l) ± 15mg/dl (0.83 mmol/l) ± 15% 5/21

System Accuracy Evaluation of The Clarke error grid (CEG) analysis 4 was part of ISO guideline to quantify the clinical accuracy of blood glucose readings generated by meters as compared to a reference value. According to ISO guideline, the error grids subdivided into five zones. Values in zones A and B represent accurate or acceptable glucose results which have no effect on clinical action. If values fall into in zone C, it may prompt unnecessary corrections that could impact on clinical outcome. Values in zone D could lead to significant medical risk for patients and values in zone E could have dangerous consequence resulted from an inappropriate treatment. To help the treatment for type I diabetes patients, ISO guideline requires 99% of individual glucose measured values shall fall within zones A and B of the CEG. The objective for this study was to access the accuracy of Fora based on ISO15197 2003 protocol and if possible, the new ISO 2013 guideline. 2. Material and Methods 2.1 Recruitment of test subjects: Test subjects were recruited to AMCR Institute based on the inclusion and exclusion criteria set from the study protocol. Inclusion: Male or female subjects with diabetes type 1 or 2 or healthy subjects, potentially including the employees of the sponsor. Minimum age of 18 years. Exclusion: Pregnancy or lactation period Severe acute disease Severe chronic disease with potential risk during the trial Discrepancy between 2 YSI references. According to BS EN ISO 15197: 2013(E), results from the reference method were evaluated to verify sample stability. If the values between first and last reference differ by >4% at glucose 100mg/dl ( 5.55mmol/l) or >4mg/dl (>0.22mmol/l) at glucose <100mg/dl (<5.55mmol/l), indicating glucose instability in the sample, the results for that sample had to be rejected. 2.2 Blood glucose monitoring system (BGMS) Fora glucose monitoring systems are market-ready glucose meters with FDA approval # K111890. Each comes with complete packaging, manual and quick user guide. Twelve meters were used in this study. They were divided into 2 stations with six at each station. Meter: Serial number Station 428311428000A01-A06 1 428311428000A07-A12 2 6/21

System Accuracy Evaluation of Key features of Fora monitoring system: Blood sample: Capillary and venous blood Sample volume: 0.5 l Measuring range: 20-600 mg/dl (1.11-33.3 mmol/l) Analysis time: 5 seconds Operating temperature: 10-40 Operating humidity: < 85% R.H. Hematocrit range: 20-60 % Measurement technology: Glucose dehydrogenase (GDH-FAD) Calibration: Plasma The evaluation was performed with 3 lots of test strips. Reagent system: Blood glucose test strip: Lot Lot number Expiry 1 TD14D228-C0E 2016-01 2 TD14D828-C0E 2016-01 3 TD14D928-C0E 2016-01 Control solutions were used to verify the performance and function of the meters each morning during the study. Control solution Lot number Expiry Control Solution Level 2 WA13B901 2015-02 Target range Lot 1: 138~186 Lot 2: 139~187 Lot 3: 137~185 2.3 Reference standard The reference used in this study was a Yellow Springs 2300 (YSI 2300) manufactured by YSI incorporated (Yellow Springs, OH) which detected glucose concentration based on a glucose oxidase method The readings of the YSI analyzer was validated by running the analyzer with the National Institute of Standards and Technology (NIST) secondary reference material SRM 965a which consists of four levels of standard glucose concentrations. Glucose reference was determined as the average of at least duplicated measurements from the YSI. 7/21

System Accuracy Evaluation of 2.4 Preparation of Samples Capillary blood samples were collected based on the ISO 15197:2013 guideline to have certain percentage of subject samples in the following concentration categories: Concentration category Percentage of samples [%] Glucose concentration [mg/dl (mmol/l)] Number of test subjects based on 100 1 5 50 ( 2.77) 5 2 15 > 50-80 (> 2.77-4.44) 15 3 20 > 80-120 (> 4.44-6.66) 20 4 30 > 120-200 (> 6.66-11.10) 30 5 15 > 200-300 (> 11.10-16.65) 15 6 10 > 300-400 (> 16.65-22.20) 10 7 5 > 400 (> 22.20) 5 Samples were assigned to the respective glucose concentration category depending on the mean from the YSI measurements. If the total number of test subjects on each concentration category was filled, no additional samples would be added. According to the ISO 15197 guideline, the following samples were adjusted by either natural decayed at 37ºC or spiked with additional glucose to fall into specific concentration categories. Concentration category Sample no. 1 85, 96, 97, 104 2 84, 86, 95, 99, 100, 101, 102, 103, 105, 106, 107 7 89, 93, 98 2.5 Test of Blood Glucose Sample capillary blood was obtained by a finger stick using a 25G safety lancet. The blood sample was immediately collected onto a Lithium-Heparin Microvette (~ 200 μl) The capillary blood was then placed on a parafilm and tested on Fora blood glucose monitoring systems (6 devices per station with test strip lot 1, 2, and 3). The remaining blood in the lithium-heparin microvette was then immediately placed on a centrifuge to separate plasma. The glucose concentration of the plasma was then determined by the YSI 2300 using one electrode. The measurement was repeated once and the true glucose concentration of the subject glucose was determined by the average of the YSI values. 8/21

System Accuracy Evaluation of 2.6 Statistical analysis In this study, the following statistical analyses were performed: Bias analysis according to Bland and Altman 5. Regression analysis according to Passing and Bablok 6. 3. Results 3.1 Test subjects Total of 108 test subjects were enrolled in the study. Among them, 8 test subjects were excluded for the following reasons. Reagent system lot 1 2 3 total test subjects 108 108 108 Number of subjects rejected Based on ISO 15197: 2013 (E) criteria The change between first (before the measurement procedure) and second (after the measurement procedure) comparison measurement result is > 4 % at glucose 1 1 1 concentrations > 100 mg/dl or > 4 mg/dl at glucose concentrations 100 mg/dl (acceptance criterion for sample stability) The concentration category was already filled 1 1 1 Additional exclusion criteria based on Fora092614-01 protocol HCT is high than 50% or below 35% 6 6 6 9/21

System Accuracy Evaluation of The detail test log Reagent system lot 1 2 3 Number of included samples 100 100 100 Glucose concentration range (YSI 2300 STAT Plus TM glucose analyzer) minimum maximum 37 474.5 37 474.5 37 474.5 Hematocrit range [%] 35.0 50.0 35.0 50.0 35.0 50.0 Age [years] 18-76 18-76 18-76 Type 1 / Type 2 / NA 53 / 36 / 19 53 / 36 / 19 53 / 36 / 19 Gender [male / female / unknown] 48 / 50 / 10 48 / 50 / 10 48 / 50 / 10 Temperature [ ] (during the test) 71.4 78.8 71.4 78.8 71.4 78.8 Humidity [%] (during the test) 43.0 55.0 43.0 55.0 43.0 55.0 3.2 Test results 3.2.1 Accuracy results following ISO 15197:2013 (E) Summary: Glucose concentration range: 37 mg/dl (2.06 mmol/l) to 474.5 mg/dl (26.4 mmol/l) Test strip lot 1: Lot: TD14D228-C0E Within ± 15 mg/dl & ± 15 % (Within ± 0.83 mmol/l & ± 15 %) 198 / 200 (99.0 %) Test strip lot 2: Lot: TD14D828-C0E Within ± 15 mg/dl & ± 15 % (Within ± 0.83 mmol/l & ± 15 %) 199 / 200 (99.5 %) 10/21

System Accuracy Evaluation of Test strip lot 3: Lot: TD14D928-C0E Within ± 15 mg/dl & ± 15 % (Within ± 0.83 mmol/l & ± 15 %) 194 / 200 (97.0 %) All three lots: Within Consensus Error Grid zones A and B 600 / 600 (100 %) Conclusion: The Fora BGMS met the requirements of new ISO standard (ISO 15197:2013). Detail results: System accuracy results for glucose concentrations < 100 mg/dl (5.55 mmol/l) Reagent system lot Within ± 5 mg/dl (Within ± 0.28 mmol/l) Within ± 10 mg/dl (Within ± 0.56 mmol/l) Within ± 15 mg/dl (Within ± 0.83 mmol/l) TD14D228-C0E 47 / 64 (73.4 %) 61 / 64 (95.3 %) 64 / 64 (100 %) TD14D828-C0E 50 / 64 (78.1 %) 61 / 64 (95.3 %) 63 / 64 (98.4 %) TD14D928-C0E 49 / 64 (76.6 %) 64 / 64 (100 %) 64 / 64 (100 %) System accuracy results for glucose concentrations 100 mg/dl (5.55 mmol/l) Reagent system lot Within ± 5 % Within ± 10 % Within ± 15 % TD14D228-C0E 72 / 136 (52.9 %) 118 / 136 (86.8 %) 134 / 136 (98.5 %) TD14D828-C0E 59 / 136 (43.4 %) 109 / 136 (80.2 %) 136 / 136 (100 %) TD14D928-C0E 64 / 136 (47.1 %) 108 / 136 (79.4 %) 130 / 136 (95.6 %) System accuracy results for glucose concentrations between 37 mg/dl (2.06 mmol/l) and 474.5 mg/dl (26.4 mmol/l) Reagent system lot Within ± 5 mg/dl & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) Within ± 10 mg/dl & ± 10 % (Within ± 0.56 mmol/l & ± 10 %) Within ± 15 mg/dl & ± 15 % (Within ± 0.83 mmol/l & ± 15 %) TD14D228-C0E 144 / 200 (72.0 %) 192 / 200 (96.0 %) 197 / 200 (98.5 %) TD14D828-C0E 142 / 200 (71.0 %) 195 / 200 (97.5 %) 197 / 200 (98.5 %) TD14D928-C0E 139 / 200 (69.5 %) 192 / 200 (96.0 %) 194 / 200 (97.0 %) 11/21

System Accuracy Evaluation of 3.2.2 Accuracy results following ISO 15197:2003 Summary: Glucose concentration range: 37 mg/dl (2.06 mmol/l) to 474.5 mg/dl (26.4 mmol/l) Test strip lot 1: Lot: TD14D228-C0E Within ± 15 mg/dl & ± 20 % (Within ± 0.83 mmol/l & ± 20 %) 199 / 200 (99.5 %) Test strip lot 2: Lot: TD14D828-C0E Within ± 15 mg/dl & ± 20 % (Within ± 0.83 mmol/l & ± 20 %) 199 / 200 (99.5 %) Test strip lot 3: Lot: TD14D928-C0E Within ± 15 mg/dl & ± 20 % (Within ± 0.83 mmol/l & ± 20 %) 200 / 200 (100.0 %) All three lots: Within Consensus Error Grid zones A and B 600 / 600 (100 %) Conclusion: Fora BGMS also is in compliance with the requirements of DIN EN ISO 15197:2003 for all 3 reagent system lot(s). 12/21

System Accuracy Evaluation of Detail results: System accuracy results for glucose concentrations < 75 mg/dl (4.2 mmol/l) Reagent system lot Within ± 5 mg/dl (Within ± 0.28 mmol/l) Within ± 10 mg/dl (Within ± 0.56 mmol/l) Within ± 15 mg/dl (Within ± 0.83 mmol/l) TD14D228-C0E 29 / 38 (76.3 %) 36 / 38 (94.7 %) 38 / 38 (100 %) TD14D828-C0E 32 / 38 (84.2 %) 35 / 38 (92.1 %) 37 / 38 (97.4 %) TD14D928-C0E 31 / 38 (81.6 %) 38 / 38 (100 %) 38 / 38 (100 %) System accuracy results for glucose concentrations 75 mg/dl (4.2 mmol/l) Reagent system lot Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 % TD14D228-C0E 88 / 162 (54.3 %) 142 / 162 (87.7 %) 160 / 162 (98.8 %) 161 / 162 (99.4 %) TD14D828-C0E 75 / 162 (46.3 %) 134 / 162 (82.7 %) 162 / 162 (100 %) 162 / 162 (100 %) TD14D928-C0E 81 / 162 (50.0 %) 133 / 162 (82.1 %) 156 / 162 (96.3 %) 162 / 162 (100 %) System accuracy results for glucose concentrations between 37 mg/dl (2.06 mmol/l) and 474.5 mg/dl (26.4 mmol/l) Reagent system lot Within ± 5 mg/dl & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) Within ± 10 mg/dl & ± 10 % (Within ± 0.56 mmol/l & ± 10 %) Within ± 10 mg/dl & ± 15 % (Within ± 0.56 mmol/l & ± 15 %) Within ± 15 mg/dl & ± 20 % (Within ± 0.83 mmol/l & ± 20 %) TD14D228-C0E 88 / 162 (54.3 %) 142 / 162 (87.7 %) 160 / 162 (98.8 %) 161 / 162 (99.4 %) TD14D828-C0E 75 / 162 (46.3 %) 134 / 162 (82.7 %) 162 / 162 (100 %) 162 / 162 (100 %) TD14D928-C0E 81 / 162 (50.0 %) 133 / 162 (82.1 %) 156 / 162 (96.3 %) 162 / 162 (100 %) 13/21

System Accuracy Evaluation of Consensus Error Grid for with three reagent system lots Region Number Percent A 600 100.00 % B 0 0.00 % C 0 0.00 % D 0 0.00 % E 0 0.0 14/21

System Accuracy Evaluation of 3.2.3 Statistical Analysis Summary of bias analysis (Bland and Altman) n=200 Reagent system lot 1: TD14I615-CDC Reagent system lot 2: TD14I815-CDC Reagent system lot 3: TD14I915-CDC Bias 95% Limits of agreement Bias [%] 95% Limits of agreement [%] -3.3-30.1 to 23.6-2.6-15.3 to 10.2-2.5-31.2 to 26.2-2.2-15.6 to 11.2-2.6-29.8 to 24.7-2.1-15.6 to 11.4 15/21

Summary of regression analysis (Passing and Bablok) Fora092614-01 System Accuracy Evaluation of n=200 Regression Reagent system lot 1: TD14D228-C0E Reagent system lot 2: TD14 D828-C0E Reagent system lot 3: TD14 D928-C0E Y=-4.68+1.01X Y=-5.90+1.02X Y=-4.95+1.01X 16/21

System Accuracy Evaluation of Blood Glucose Monitoring System 3.2.4 Absolute differences between and YSI 2300 STAT PLUS 17/21

System Accuracy Evaluation of 4. Conclusion and discussion: This study showed that the Fora blood glucose monitoring system not only met the current accuracy standard (ISO15197:2003), but also exceeded the minimum acceptable accuracy standard published in the newer 2013 guideline (ISO15197:2013) when compared the test results with a laboratory reference. In addition, 99% of the data points fall within Zone A & B of Consensus Error Grid, which means that when user obtained a value using Fora monitor, it should not result in a clinical decision that could be deemed inappropriate. There are several glucose monitoring systems out in the market. Since FDA is in preparation of tightening the accuracy standard to ± 15% by adopting the new ISO15197:2013 standard. Based on the results, it will be reasonable assumption that Fora met the new ISO standard, and therefore would be a reasonable selection for users if they like to use meter with a higher accuracy. Reference a. 2013 International Diabetes Federation, the global burden. http://www.idf.org/diabetesatlas/5e/the-global-burden b. In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. EN ISO 15197:2003. c. In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013. d. Parkes JL, Slatin SL, Pardo S, Ginsberg BH: A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000; 23:1143-1148. e. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1:307-10. f. Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983; 21:709-20. 18/21

System Accuracy Evaluation of Blood Glucose Monitoring System Appendix Raw data with adjusted samples marked Subject- ID Diabetes type [1/2/NA] Sex [f/m] Age [years] Date Temperature [ ] Humidity [%] Haematocrit (meas.) [%] adjusted glucose category sampling time value2 sampling time Lot: TD14D228-C0E Lot: TD14D828-C0E Lot: TD14D928-C0E 1 NA m 26 2014/10/13 71.8 53 42-07:11 07:13 115 115 108 105 107 104 107 107 2 2 m 57 2014/10/13 73.6 51 40-08:09 08:10 306 300 332 319 318 332 328 337 3 2 m 54 2014/10/13 73.2 50 44-08:28 08:29 226 225 217 226 225 206 214 207 4 1 f 20 2014/10/13 74.1 51 45-08:45 08:47 294 297 282 269 283 289 285 283 5 NA m 64 2014/10/13 73.4 52 44-09:05 09:07 126 124 114 113 112 109 113 109 6 NA f 60 2014/10/13 71.4 49 41-09:28 09:30 93.2 91 87 87 88 83 89 89 7 NA m 26 2014/10/13 74.5 51 49-10:00 10:02 103 102 92 93 89 89 89 87 8 NA f 36 2014/10/13 74.1 48 46-10:11 10:13 99 99.9 95 98 94 97 93 95 9 NA f 29 2014/10/13 75.5 54 43-10:34 10:36 97.4 96 94 94 89 92 90 91 10 NA m 29 2014/10/13 74.5 49 44-10:54 10:56 97.8 96 91 93 92 95 94 95 11 NA m 31 2014/10/13 74.1 46 41-11:12 11:14 104 104 97 93 90 94 90 92 12 NA m 55 2014/10/13 73.9 49 40-13:06 13:07 121 122 135 124 115 128 125 126 14 1 m 56 2014/10/13 74.3 49 41-13:29 13:31 69.4 68.9 67 65 60 67 67 65 15 1 f 21 2014/10/13 74.1 49 35-13:51 13:53 141 139 149 142 150 150 146 149 16 2 m 64 2014/10/13 75.2 50 39-14:39 14:41 245 239 236 226 238 224 235 235 18 1 m 19 2014/10/13 75 50 49-14:53 14:55 95.1 100 87 89 88 90 94 91 19 1 f 41 2014/10/13 74.5 49 38-15:32 15:33 124 121 128 131 123 119 116 126 20 2 NA 44 2014/10/13 74.5 49 36-15:35 15:37 96.8 97.4 94 99 97 95 96 94 21 1 f 23 2014/10/13 74.8 49 45-15:56 15:58 144 145 130 131 129 129 127 122 22 1 f 34 2014/10/13 74.8 48 40-16:03 16:05 196 196 204 203 207 209 214 207 23 2 f 35 2014/10/14 72.7 53 38-07:21 07:25 140 139 141 142 138 141 143 144 24 2 m 68 2014/10/14 73.2 53 39-07:37 07:38 136 137 146 143 146 150 151 152 25 1 m 33 2014/10/14 73.2 53 46-07:43 07:46 132 134 120 129 129 128 123 122 26 1 m 34 2014/10/14 73.9 53 45-08:08 08:10 196 192 181 179 174 176 175 170 27 1 f 55 2014/10/14 74.1 53 38-08:44 08:46 202 198 220 215 224 224 228 214 28 2 f 71 2014/10/14 73.6 52 43-09:18 09:20 143 137 144 140 140 141 145 151 29 2 m 60 2014/10/14 73.6 54 43-09:21 09:23 194 194 184 189 183 188 180 173 30 1 f 64 2014/10/14 74.1 53 38-09:37 09:40 38 41.5 39 40 39 43 43 41 31 1 m 55 2014/10/14 73.9 54 47-09:59 10:01 311 311 272 272 269 268 274 269 32 1 f 24 2014/10/14 74.5 53 43-10:14 10:16 317 319 309 309 319 318 316 331 33 2 f 58 2014/10/14 74.5 50 43-10:30 10:31 280 283 275 284 271 268 267 269 34 NA f 39 2014/10/14 74.5 54 43-10:50 10:52 136 136 136 136 134 138 133 140 35 1 m 66 2014/10/14 75 50 50-11:44 11:45 317 315 276 273 273 290 288 284 36 1 f 54 2014/10/14 74.5 49 38-11:47 11:49 148 151 144 157 139 139 143 144 37 1 NA 52 2014/10/14 74.8 49 40-13:20 13:22 189 187 183 189 184 208 188 191 38 2 m 56 2014/10/14 74.5 49 38-13:39 13:41 277 274 260 267 274 253 253 271 39 1 f 27 2014/10/14 74.5 48 44-13:45 13:46 274 276 272 283 286 271 277 282 40 1 f 41 2014/10/14 74.3 48 46-14:07 14:09 79.8 77.6 77 74 77 77 77 80 41 1 f 24 2014/10/14 74.5 48 48-14:41 14:43 400 407 415 398 388 394 389 362 42 1 f 46 2014/10/14 74.8 48 39-15:07 15:08 375 369 403 397 405 403 395 429 19/21

System Accuracy Evaluation of Blood Glucose Monitoring System Subject- ID Diabetes type [1/2/NA] Sex [f/m] Age [years] Date Temperature [ ] Humidity [%] Haematocrit (meas.) [%] adjusted glucose category sampling time value2 sampling time Lot: TD14D228-C0E Lot: TD14D828-C0E Lot: TD14D928-C0E 43 2 m 72 2014/10/14 74.8 48 49-15:30 15:32 109 108 103 96 102 106 97 91 44 2 m 60 2014/10/14 74.8 48 43-15:43 15:49 56.6 58.7 58 57 57 56 59 61 45 1 m 35 2014/10/14 74.3 52 48-07:21 07:23 335 329 303 285 307 308 316 337 46 1 f 40 2014/10/14 74.3 49 43-07:45 07:47 92.8 91.1 85 89 84 86 84 86 47 2 f 67 2014/10/14 73.4 52 43-08:02 08:03 185 185 189 192 189 190 188 184 48 2 f 59 2014/10/14 73.9 52 41-08:44 08:47 160 156 161 153 150 154 154 155 49 2 f 76 2014/10/14 73.6 50 43-09:01 09:03 88.8 91 92 92 90 87 93 91 50 2 f 50 2014/10/15 74.1 51 46-09:27 09:28 149 150 137 134 133 132 126 127 51 1 m 33 2014/10/15 73.4 53 46-09:38 09:40 137 139 132 128 127 130 134 131 52 1 m 43 2014/10/15 73.4 50 45-10:14 10:16 414 405 403 400 396 401 411 397 53 1 m 29 2014/10/15 73.9 53 48-10:35 10:38 140 140 143 141 141 135 127 127 54 1 f 58 2014/10/15 73,.6 53 44-11:08 11:09 237 231 233 228 229 235 225 238 55 1 m 55 2014/10/15 74.3 53 49-11:34 11:36 105 104 91 83 94 98 95 98 56 1 m 20 2014/10/15 73.9 52 39-12:58 13:00 164 165 161 164 161 164 163 165 57 1 f 61 2014/10/15 74.1 53 38-13:13 13:14 227 227 241 227 249 250 247 233 58 2 m 56 2014/10/15 74.5 55 45-13:37 13:39 113 111 111 111 112 110 111 112 59 1 m 47 2014/10/15 74.3 50 49-14:01 14:05 259 260 224 226 230 231 232 228 60 2 m 62 2014/10/15 74.8 52 46-14:36 14:37 177 176 179 168 174 181 176 178 61 2 m 64 2014/10/15 74.3 53 40-14:52 14:53 190 190 207 195 203 205 204 204 62 1 f 18 2014/10/15 75 52 41-15:09 15:10 106 109 100 98 103 102 96 100 63 2 NA 54 2014/10/15 74.5 50 43-15:45 15:47 124 125 121 119 122 118 129 118 64 1 m 27 2014/10/16 72.7 51 45-07:36 07:37 227 223 229 212 213 220 231 224 65 NA NA 60 2014/10/16 73.2 51 40-07:53 07:55 88.6 92.7 90 90 93 91 93 81 66 2 m 51 2014/10/16 73.6 51 49-08:11 08:13 239 235 246 238 239 242 239 238 67 1 m 26 2014/10/16 73.9 51 45-08:33 08:35 146 144 131 127 140 128 138 127 68 1 f 28 2014/10/16 73.6 50 47-08:56 08:57 123 120 117 117 115 118 117 121 69 1 f 66 2014/10/16 73.2 52 41-09:11 09:12 87.1 90 89 89 89 88 89 90 70 2 NA 61 2014/10/16 73.6 51 44-09:40 09:42 224 219 225 212 224 220 218 227 71 1 m 61 2014/10/16 74.1 50 50-11:11 11:13 60.8 60.4 56 56 56 57 57 56 72 1 m 43 2014/10/16 73.6 46 42-10:47 10:49 371 370 356 352 339 351 339 360 73 1 f 28 2014/10/16 74.1 47 45-11:24 11:27 317 313 289 290 286 292 297 292 74 2 f 51 2014/10/16 74.1 47 44-13:12 13:13 94 92.7 98 99 98 99 99 97 75 2 f 60 2014/10/16 74.2 49 39-13:39 13:41 121 118 117 118 111 111 119 121 76 1 NA 42 2014/10/16 74.5 48 43-14:09 14:11 170 168 156 155 151 157 157 156 79 1 NA 23 2014/10/16 74.5 49 48-14:55 14:57 161 159 147 144 145 143 146 145 80 1 f 30 2014/10/16 78.8 43 38-15:23 15:25 232 234 226 228 233 230 235 235 81 1 f 59 2014/10/16 78.8 43 38-15:20 15:22 260 259 255 256 252 253 255 252 82 2 f 52 2014/10/16 74.8 51 38-15:43 15:44 319 312 333 338 324 335 332 325 84 NA f 51 2014/10/17 74.1 52 45 2 16:21 16:23 49.3 51.7 51 46 48 52 49 47 85 NA f 31 2014/10/17 74.1 54 45 1 16:39 16:41 40.6 40.1 36 37 36 39 35 37 20/21

System accuracy evaluation of FORA Test N Go Blood Glucose Monitoring System versus YSI 2300 STAT Plus glucose analyzer following ISO 15197:2013