Our Store
866-216-5308
CALL-TOLL-FREE

Professional

Clinical Accuracy Testing Data

The accuracy of the Infinity Automatic Coding Blood Glucose Monitoring System System was assessed by comparing blood glucose results obtained by patients with those obtained using the Hitachi Glucose Auto analyzer 747, a laboratory instrument. Glucose levels were measured by 160 diabetic patients at three different clinical centers.

A fine and direct correlation between the Hitachi 747 and the Infinity Automatic Coding Blood Glucose Monitoring System was confirmed in 160 blood samples with the correlation coefficient R=0.9832 (Figure 1). The results indicate the Infinity Automatic Coding Blood Glucose Monitoring System generates similar results as the Hitachi 747, a laboratory instrument used in hospitals to test glucose concentration. The data further demonstrates compliance with the international standard ISO151197 and is within acceptance criteria.

Figure 1: Linear regression of the 160 blood glucose samples with the Hitachi 747 vs. G5 INFINITY® System at the Clinical Centers.

Test Range 38 ~ 496 mg/dL
sample No = 160
data No = 320

Table 1: Glucose concentration of sample for system accuracyevaluation

glucose concentration (mg/dL)

percentage of sample

sample #

< 50

5%

8

50 to 80

15%

24

80 to 120

20%

32

120 to 200

30%

48

201 to 300

15%

24

301 to 400

10%

16

> 400

5%

8

SUM

100%

160

User Performance Evaluation

Procedure:

To test the accuracy of the Infinity Automatic Coding Blood Glucose Monitoring System , 150 individuals participated in a study at three clinical sites- 50 users at each site.
The participants were each provided with an Infinity Automatic Coding Blood Glucose Monitoring System labeled and packaged as it would be for the United States market in English. The testers were given sufficient time to read and understand instructions and the contents of the Infinity® system (on their own). Participants did not receive additional training, other instruction, assistance, or training material.

The individuals performed their own finger sticks and test themselves using Infinity Automatic Coding Blood Glucose Monitoring System without supervision other than that necessary to insure that accurate results were properly recorded. Subsequently, healthcare professionals gathered user’s capillary whole blood by skin puncture and measured the glucose using the same Infinity Automatic Coding Blood Glucose Monitoring System system. By additional skin puncture within 5 min of G5 INFINITY® test, healthcare professional gathered capillary whole blood in the capillary anticoagulant tube. This capillary whole blood was centrifuged, and then this plasma’s glucose was measured by the HITACHI 747.

Conclusion:

As shown in the figures below, the results show a fine correlation in accuracy between layperson and healthcare professionals with the correlation of R2 = 0.9849. As a result, the data shown indicates that the results satisfy the accuracy standard of ISO15197 and is within acceptance criteria.

DATA RESULTS

Figure 1. Linear regression of the 150 blood glucose samples with the Hitachi 747 vs. G5 INFINITY® System at the Clinical Centers.

Samples No=150
Test range = 50~537 mg/dL

Samples No=150
Test range = 50~537 mg/dL

Figure 2. Linear regression of Layperson results vs. Healthcare professional results

Samples No=150
Test range = 50~537 mg/dL

DATA ANALYSIS

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

8/25 (32 %)

24/25(96 %)

25/25(100%)

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

74/125(59%)

108/125(86%)

121/125(97%)

123/125(98%)

Hematocrit Effect on Blood Glucose Measurements Study

The Hematocrit Effect Test is designed to evaluate the Hematocrit-dependent variations in the whole blood glucose measurements with the Infinity Automatic Coding Blood Glucose Monitoring System

Procedure:

The test was performed by measuring spiked glucose levels in blood samples which are prepared to contain designated level of hematocrit ( 20, 30, 40, 50, 60%) from cetriguged whole blood. The concentration of glucose was adjusted in each hematocrit percentage to eight levels: (40, 70, 110, 160, 260, 350, 450, 550mg/dL) through either hydrolyses or analytical spiking. Each sample was tested 15 times with evolution system. The plasma serum glucose value of the Hct 40% sample is measured by YSI 2300 STAT PLUS, the hematocrit of the sample is measured by NOVA STAT profile.

Conclusion:

As shown in the figures below, the results demonstrate that the Hematocrit-dependent variations in the whole blood glucose measurements with the Infinity Automatic Coding Blood Glucose Monitoring System are within the acceptable range and safe to use for blood glucose monitoring purposes.

Results of Blood Glucose and Hematocrit Range

Table 1. data results
Data unit: mg/dL

Y S I (mg/dL) of 40% Hct sample – 44 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Mean

CV

20

45

46

49

48

45

46

47

46

46

49

48

47

46

48

50

47.1

3.1

31

46

45

49

46

43

45

48

47

48

47

48

48

46

49

46

46.7

3.4

39

45

46

48

45

44

42

44

43

44

43

41

44

42

44

43

43.9

3.8

50

43

40

46

43

42

41

43

42

44

40

39

44

42

41

46

42.4

4.7

59

40

38

38

41

42

40

37

40

42

41

40

41

43

39

38

40.0

4.2

Y S I (mg/dL) of 40% Hct sample –75 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Mean

CV

21

78

79

76

76

78

75

76

79

78

79

80

79

76

78

82

77.9

2.3

30

76

74

75

76

72

78

74

75

79

76

73

75

76

77

78

75.6

2.5

41

72

73

71

72

73

72

74

76

70

71

72

72

70

74

70

72.1

2.3

51

70

66

63

66

69

68

65

66

66

70

64

68

67

67

69

66.9

3.0

60

65

69

62

65

63

65

64

67

65

63

68

65

64

65

63

64.9

2.9

Y S I (mg/dL) of 40% Hct sample – 111 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Mean

CV

21

116

118

116

120

118

115

117

115

120

118

114

123

117

117

117

117.4

1.9

29

111

115

112

108

113

116

112

111

110

114

112

113

113

115

111

112.4

1.8

42

108

109

111

112

105

109

109

110

113

110

111

110

114

111

109

110.1

1.9

51

105

103

102

106

108

109

110

102

109

111

107

106

108

108

108

106.8

2.5

59

101

102

102

105

103

106

101

105

107

105

101

105

102

105

104

103.6

1.9

Y S I (mg/dL) of 40% Hct sample – 163 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Mean

CV

20

169

170

168

169

168

165

172

173

170

169

170

171

175

171

170

170.0

1.3

33

165

167

165

166

162

166

168

166

164

162

161

165

166

168

164

165.0

1.2

41

158

156

158

159

158

156

159

160

161

158

157

158

159

162

160

158.6

1.0

49

155

153

150

152

154

158

153

150

149

152

153

153

154

156

150

152.8

1.6

60

147

152

150

146

150

140

149

146

149

143

146

144

143

147

139

146.1

2.5

Y S I (mg/dL) of 40% Hct sample – 257 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Mean

CV

22

268

269

270

267

265

266

268

263

269

270

263

268

265

267

267

267.0

0.8

32

259

258

259

263

260

251

257

254

258

257

253

256

255

259

260

257.3

1.2

40

255

253

253

256

255

251

250

255

258

257

255

254

253

254

252

254.1

0.8

50

244

250

249

248

249

253

250

249

247

250

248

244

248

249

251

248.6

0.9

59

235

236

238

233

239

241

248

243

235

239

237

233

238

236

240

238.1

1.6

Table 2. Data analysis
Data unit: Difference , mg/dL

Y S I (mg/dL) of 40% Hct sample – 44 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

20

1.1

2.1

5.1

4.1

1.1

2.1

3.1

2.1

2.1

5.1

4.1

3.1

2.1

4.1

6.1

31

2.1

1.1

5.1

2.1

-0.9

1.1

4.1

3.1

4.1

3.1

4.1

4.1

2.1

5.1

2.1

39

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

50

-0.9

-3.9

2.1

-0.9

-1.9

-2.9

-0.9

-1.9

0.1

-3.9

-4.9

0.1

-1.9

-2.9

2.1

59

-3.9

-5.9

-5.9

-2.9

-1.9

-3.9

-6.9

-3.9

-1.9

-2.9

-3.9

-2.9

-0.9

-4.9

-5.9

Y S I (mg/dL) of 40% Hct sample – 75 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

21

5.9

6.9

3.9

3.9

5.9

2.9

3.9

6.9

5.9

6.9

7.9

6.9

3.9

5.9

9.9

30

3.9

1.9

2.9

3.9

-0.1

5.9

1.9

2.9

6.9

3.9

0.9

2.9

3.9

4.9

5.9

41

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

51

-2.1

-6.1

-9.1

-6.1

-3.1

-4.1

-7.1

-6.1

-6.1

-2.1

-8.1

-4.1

-5.1

-5.1

-3.1

60

-7.1

-3.1

-10.1

-7.1

-9.1

-7.1

-8.1

-5.1

-7.1

-9.1

-4.1

-7.1

-8.1

-7.1

-9.1

Data unit: Err ,%

Y S I (mg/dL) of 40% Hct sample - 111 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

21

5.4

7.2

5.4

9.0

7.2

4.5

6.3

4.5

9.0

7.2

3.6

11.8

6.3

6.3

6.3

29

0.8

4.5

1.8

-1.9

2.7

5.4

1.8

0.8

-0.1

3.6

1.8

2.7

2.7

4.5

0.8

42

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

51

-4.6

-6.4

-7.3

-3.7

-1.9

-1.0

-0.1

-7.3

-1.0

0.8

-2.8

-3.7

-1.9

-1.9

-1.9

59

-8.2

-7.3

-7.3

-4.6

-6.4

-3.7

-8.2

-4.6

-2.8

-4.6

-8.2

-4.6

-7.3

-4.6

-5.5

Y S I (mg/dL) of 40% Hct sample - 163 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

20

6.6

7.2

5.9

6.6

5.9

4.0

8.4

9.1

7.2

6.6

7.2

7.8

10.3

7.8

7.2

33

4.0

5.3

4.0

4.7

2.1

4.7

5.9

4.7

3.4

2.1

1.5

4.0

4.7

5.9

3.4

41

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

49

-2.3

-3.5

-5.4

-4.2

-2.9

-0.4

-3.5

-5.4

-6.1

-4.2

-3.5

-3.5

-2.9

-1.6

-5.4

60

-7.3

-4.2

-5.4

-7.9

-5.4

-11.7

-6.1

-7.9

-6.1

-9.8

-7.9

-9.2

-9.8

-7.3

-12.4

Y S I (mg/dL) of 40% Hct sample – 257 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

22

5.5

5.9

6.3

5.1

4.3

4.7

5.5

3.5

5.9

6.3

3.5

5.5

4.3

5.1

5.1

32

1.9

1.5

1.9

3.5

2.3

-1.2

1.2

0.0

1.5

1.2

-0.4

0.8

0.4

1.9

2.3

40

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

50

-4.0

-1.6

-2.0

-2.4

-2.0

-0.4

-1.6

-2.0

-2.8

-1.6

-2.4

-4.0

-2.4

-2.0

-1.2

59

-7.5

-7.1

-6.3

-8.3

-5.9

-5.1

-2.4

-4.4

-7.5

-5.9

-6.7

-8.3

-6.3

-7.1

-5.5

Y S I (mg/dL) of 40% Hct sample –371 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

20

6.0

6.8

6.2

6.8

3.0

5.4

6.0

6.8

4.9

6.0

6.8

7.0

6.2

4.9

6.8

32

3.0

1.7

3.3

1.7

1.2

1.7

2.2

4.1

3.0

1.7

0.6

4.1

1.7

2.0

2.2

40

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

55

-5.8

-4.7

-5.0

-3.7

-4.7

-6.1

-4.7

-5.5

-1.5

-5.0

-4.2

-3.9

-5.0

-5.8

-7.1

58

-8.7

-7.4

-6.9

-8.5

-9.3

-8.5

-9.0

-7.7

-7.9

-7.4

-9.8

-9.0

-8.5

-6.9

-8.7

Y S I (mg/dL) of 40% Hct sample – 438 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

20

9.0

8.7

8.3

9.2

9.0

9.4

8.7

10.1

9.2

9.9

8.5

7.5

6.8

9.7

9.4

29

5.9

6.1

5.9

5.7

5.2

6.1

6.8

5.4

4.2

8.3

6.4

4.2

5.4

6.1

4.2

41

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

50

-3.1

-4.3

-2.6

-2.4

-1.7

-5.0

-3.6

-3.3

-2.6

-3.1

-3.1

-1.7

-2.4

-3.1

-3.8

60

-5.2

-4.7

-4.7

-4.3

-3.6

-2.6

-3.8

-4.0

-4.7

-2.6

-3.6

-1.4

-5.2

-4.0

-5.5

Y S I (mg/dL) of 40% Hct sample – 543 mg/dL

Hct %

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

21

7.8

9.3

7.5

7.8

8.6

9.3

7.3

7.8

7.5

8.0

7.7

9.0

7.8

7.5

7.5

33

3.0

1.9

2.5

3.6

1.9

1.4

3.0

3.2

2.8

2.5

1.9

2.3

3.6

3.4

2.1

43

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 

52

-3.6

-5.3

-4.2

-5.1

-3.8

-5.1

-4.8

-2.2

-3.3

-4.0

-3.3

-3.1

-4.4

-4.2

-4.2

59

-9.4

-7.5

-8.1

-7.9

-7.5

-7.4

-9.2

-8.1

-8.3

-9.2

-8.1

-9.0

-9.6

-8.8

-9.2

Table 3. Summary of results

Y S I ( mg/dL)

number of samples within
± 10 mg/dL

percentage of sample

number of samples within
± 15 mg/dL

percentage of sample

Criteria

< 75 mg/dL

119

99%

120

100%

PASS

At < 75 mg/dL sample, total test number is 120

Y S I ( mg/dL)

number of samples within
± 10 % error

percentage of sample

number of samples within
± 15 % error

percentage of sample

Criteria

≥ 75 mg/dL

356

99%

360

100%

PASS

At ≥ 75 mg/dL sample, total test number is 360

Interference Studies

Many monitors approved for home use give the wrong result if patients are taking certain drugs like Tylenol (acetaminophen), vitamin C (ascorbic acid) or maltose (a by=product of a common drug used in dialysis). The tests described in this section are designed to evaluate the effect of various potentially interfering substances in whole blood samples on glucose measurements using the Infinity Automatic Coding Blood Glucose Monitoring System.

Procedure:

DOSE-RESPONSE METHOD (NCCLS EP7-P)
This test (as seen in Table 1, below) is designed to determine the relationship between the concentration of the interferent and the magnitude of its interference. A series of test samples, systematically varying in the concentration of the interferent, is prepared by making quantitative, volumetric admixtures of two pools: one at the highest concentration to be tested and the other at the lowest. The substances and concentration of the interferents are recommended at NCCLS EP7-P and draft document of FDA.
Test series (intermediate pools) – see Table 1
The test samples containing intermediate concentration of the interferent are prepared quantitatively from high and low pools. The preparation scheme is illustrated in Fig 3.

Figure 1: Illustration Scheme of Interferent Testing

In order to understand the table below, the preparation scheme for the first interferent on the table, Acetaminophen will be used as the example. The sample used may reach as high as 20mg/dl in serum (refer to Appendix A, NCCLS EP7-P).
In this substance, the Acetaminophen, the potential interference is not present in the low pool. Approximately 7 ml of blood was taken from a healthy individual who is not under medication. To increase the pool “High Pool”, 62mg of Acetaminophen was dissolved into 10ml of phosphate buffer and pipette of 100ul of the interferent solution into 3ml blood sample. At the same time 100ul of the phosphate buffer was added without the interefrent substance into 3ml blood sample to make the “Low Pool.” As a result, the 62mg of Acetaminophen with the 10ml buffer added to 0.1ml/3mlblood resulted in (0.2067mg/ml=20.6mg/dl) in the High pool.
Interferences with difference ± 15% should be written on the strip insert with notice sentence.

Conclusion

The interference tests confirms that the tested inferents is less than ±10% in the presence of common interferents even beyond the accepted clinically significant ranges.

Table 1: Interferences

Acetaminophen

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

5 mg/dL

10 mg/dL

15 mg/dL

20 mg/dL

Rep. 1

162

160

162

165

160

Rep. 2

163

159

162

163

163

Rep. 3

164

163

163

164

160

Rep. 4

163

164

160

162

158

Rep. 5

162

165

167

160

164

Mean

162.8

162.2

162.8

162.8

161

% Difference

0.0

-0.4

0.0

0.0

-1.1

Bilirubin

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

10 mg/dL

20 mg/dL

30 mg/dL

40mg/dL

Rep. 1

154

154

153

146

147

Rep. 2

158

151

150

152

146

Rep. 3

152

152

152

150

142

Rep. 4

154

152

151

147

143

Rep. 5

157

153

150

146

145

Mean

155

152.4

151.2

148.2

144.6

% Difference

0.0

-1.7

-2.5

-4.4

-6.7

Gentistic acid

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

12.5mg/dL

25 mg/dL

37.5mg/dL

50 mg/dL

Rep. 1

162

165

165

169

173

Rep. 2

163

163

169

167

171

Rep. 3

164

168

167

169

177

Rep. 4

163

164

168

174

175

Rep. 5

162

169

169

170

176

Mean

162.8

165.8

167.6

169.8

174.4

% Difference

0.0

1.8

2.9

4.3

7.1

Levo-Dopa

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

1 mg/dL

2mg/dL

3 mg/dL

4 mg/dL

Rep. 1

155

155

156

154

154

Rep. 2

158

159

159

156

154

Rep. 3

156

153

152

157

153

Rep. 4

155

157

158

152

154

Rep. 5

155

155

158

158

150

Mean

155.8

155.8

156.6

155.4

153

% Difference

0.0

0.0

0.5

-0.3

-1.8

 

Metyl-Dopa

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

0.6 mg/dL

1.25 mg/dL

1.8 mg/dL

2.5 mg/dL

Rep. 1

155

151

153

154

156

Rep. 2

158

159

156

152

154

Rep. 3

156

159

152

154

158

Rep. 4

155

154

157

155

154

Rep. 5

155

157

158

155

157

Mean

155.8

156

155.2

154

155.8

% Difference

0.0

0.1

-0.4

-1.2

0.0

Tolazamide

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

1.25mg/dL

2.5 mg/dL

7.5 mg/dL

5 mg/dL

Rep. 1

154

157

158

160

163

Rep. 2

158

156

155

157

160

Rep. 3

152

154

156

158

161

Rep. 4

154

156

158

159

162

Rep. 5

157

159

158

160

161

Mean

155

156.4

157

158.8

161.4

% Difference

0.0

0.9

1.3

2.5

4.1

Dopamine

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

3.25 mg/dL

6.5 mg/dL

9.7 mg/dL

13 mg/dL

Rep. 1

162

159

160

163

166

Rep. 2

163

160

163

164

165

Rep. 3

164

167

160

162

166

Rep. 4

163

164

161

160

160

Rep. 5

162

165

164

160

166

Mean

162.8

163

161.6

161.8

164.6

% Difference

0.0

0.1

-0.7

-0.6

1.1

Ascorbate

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

0.75mg/dL

1.5 mg/dL

2.25mg/dL

3 mg/dL

Rep. 1

162

162

165

169

168

Rep. 2

163

162

169

164

169

Rep. 3

164

168

163

164

167

Rep. 4

163

164

163

168

169

Rep. 5

162

160

164

167

170

Mean

162.8

163.2

164.8

166.4

168.6

% Difference

0.0

0.2

1.2

2.2

3.6

EDTA

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

160 mg/dL

320 mg/dL

480 mg/dL

640 mg/dL

Rep. 1

162

168

166

170

166

Rep. 2

163

163

169

169

169

Rep. 3

164

165

167

174

174

Rep. 4

163

163

164

166

170

Rep. 5

162

164

165

165

171

Mean

162.8

164.6

166.2

168.8

170.0

% Difference

0.0

1.1

2.1

3.7

4.4

Glutathione

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

0.25 mg/dL

0.5 mg/dL

0.75 mg/dL

1 mg/dL

Rep. 1

162

163

163

161

160

Rep. 2

163

163

162

160

158

Rep. 3

164

164

163

159

159

Rep. 4

163

163

161

163

160

Rep. 5

162

160

160

163

159

Mean

162.8

162.6

161.8

161.2

159.2

% Difference

0.0

-0.1

-0.6

-1.0

-2.2

Heparin

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

25 mg/dL

50 mg/dL

75 mg/dL

100 mg/dL

Rep. 1

162

160

160

160

161

Rep. 2

163

162

162

165

165

Rep. 3

164

163

163

160

163

Rep. 4

163

164

164

161

163

Rep. 5

162

162

164

163

157

Mean

162.8

162.2

162.6

161.8

161.8

% Difference

0.0

-0.4

-0.1

-0.6

-0.6

Ibuprofen

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

10 mg/dL

20 mg/dL

30 mg/dL

40 mg/dL

Rep. 1

160

159

158

154

153

Rep. 2

159

162

156

158

155

Rep. 3

162

160

158

157

154

Rep. 4

160

157

159

156

156

Rep. 5

158

158

159

158

153

Mean

159.8

159.2

158.0

156.6

154.2

% Difference

0.0

-0.4

-1.1

-2.0

-3.5

Salicylic acid

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

12.5 mg/dL

25 mg/dL

37.5 mg/dL

50 mg/dL

Rep. 1

162

160

164

160

163

Rep. 2

163

165

163

161

160

Rep. 3

164

162

162

161

161

Rep. 4

163

163

163

163

159

Rep. 5

162

164

165

161

162

Mean

162.8

162.8

163.4

161.2

161

% Difference

0.0

0.0

0.4

-1.0

-1.1

Tetracycline

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

0.1 mg/dL

0.2 mg/dL

0.3 mg/dL

0.4 mg/dL

Rep. 1

162

162

166

162

169

Rep. 2

163

163

165

167

167

Rep. 3

164

165

164

170

169

Rep. 4

163

164

163

166

171

Rep. 5

162

166

168

168

170

Mean

162.8

164.0

165.2

166.6

169.2

% Difference

0.0

0.7

1.5

2.3

3.9

Tolbutamide

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

25 mg/dL

50 mg/dL

75 mg/dL

100 mg/dL

Rep. 1

160

159

158

157

158

Rep. 2

159

159

159

156

154

Rep. 3

162

157

158

159

156

Rep. 4

160

162

161

161

158

Rep. 5

158

163

160

158

158

Mean

159.8

160.0

159.2

158.2

156.8

% Difference

0.0

0.1

-0.4

-1.0

-1.9

Urea

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

125 mg/dL

250 mg/dL

375 mg/dL

500 mg/dL

Rep. 1

162

163

165

169

175

Rep. 2

163

168

174

171

174

Rep. 3

164

169

171

173

179

Rep. 4

163

165

172

171

175

Rep. 5

162

169

170

178

176

Mean

162.8

166.8

170.4

172.4

175.8

% Difference

0.0

2.5

4.7

5.9

8.0

Uric acid

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

5 mg/dL

10 mg/dL

15 mg/dL

20 mg/dL

Rep. 1

154

135

139

142

143

Rep. 2

158

137

136

148

148

Rep. 3

152

135

144

150

157

Rep. 4

154

136

139

144

150

Rep. 5

157

136

138

144

156

Mean

155.0

135.8

139.2

145.6

150.8

% Difference

0.0

-12.4

-10.2

-6.1

-2.7

Creatinine

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

7.5 mg/dL

15 mg/dL

22.5 mg/dL

30 mg/dL

Rep. 1

162

160

162

163

160

Rep. 2

163

161

163

160

157

Rep. 3

164

163

160

159

159

Rep. 4

163

165

162

160

158

Rep. 5

162

163

162

160

159

Mean

162.8

162.4

161.8

160.4

158.6

% Difference

0.0

-0.2

-0.6

-1.5

-2.6

Cholesterol

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

175 mg/dL

350 mg/dL

525 mg/dL

700 mg/dL

Rep. 1

156

159

163

167

169

Rep. 2

158

160

162

164

170

Rep. 3

159

162

163

166

168

Mean

157.7

160.3

162.7

165.7

169.0

% Difference

0.0

1.7

3.2

5.1

7.2

Triglyceride

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0mg/dL

750 mg/dL

1500 mg/dL

2250 mg/dL

3000 mg/dL

Rep. 1

156

156

160

160

163

Rep. 2

153

155

155

160

160

Rep. 3

152

155

157

159

163

Mean

153.7

155.3

157.3

159.7

162.0

% Difference

0.0

1.1

2.4

3.9

5.4

Glactose

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

12.5 mg/dL

25 mg/dL

37.5 mg/dL

50 mg/dL

Rep. 1

162

163

162

160

160

Rep. 2

163

161

161

160

155

Rep. 3

164

162

161

158

158

Mean

163.0

162.0

161.3

159.3

157.7

% Difference

0.0

-0.6

-1.0

-2.2

-3.3

Xylose

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0 mg/dL

2.5 mg/dL

5mg/dL

7.5 mg/dL

10 mg/dL

Rep. 1

162

163

164

163

165

Rep. 2

163

163

161

162

163

Rep. 3

164

162

163

165

163

Mean

163.0

162.7

162.7

163.3

163.7

% Difference

0.0

-0.2

-0.2

0.2

0.4

Maltose

Pool

Low(L)

(L+M)/2

(L+H)/2(M)

(M+H)/2

High(H)

Conc.

0mg/dL

75 mg/dL

150 mg/dL

225 mg/dL

300 mg/dL

Rep. 1

162

160

159

160

153

Rep. 2

163

161

159

157

155

Rep. 3

164

160

159

156

158

Mean

163.0

160.3

159.0

157.7

155.3

% Difference

0.0

-1.6

-2.5

-3.3

-4.7

Table 2: Summary of Tested Interferences:

Mean of Test Results

Interferences

High Test Level(mg/dL)

Low (mg/dL)

High (mg/dL)

Error %

Acetaminophen

20

162.8

161.0

-1.1

Bilirubin

40

155.0

144.6

-6.7

Gentistic acid

50

162.8

174.4

7.1

Uric acid

20

155.0

150.8

-2.7

Levo-Dopa

4

155.8

153.0

-1.8

Creatinine

30

162.8

158.6

-2.6

Methyl-Dopa

2.5

155.8

155.8

0.0

Tolazamide

5

155.0

161.4

4.1

Dopamine

13

162.8

164.6

1.1

Ascorbate

3

162.8

168.6

3.6

EDTA

640

162.8

170.0

4.4

Glutathione

1

162.8

159.2

-2.2

Heparin

1,000

162.8

161.8

-0.6

Ibuprofen

40

159.8

154.2

-3.5

Salicylic acid

50

162.8

161.0

-1.1

Tetracycline

0.4

162.8

169.2

3.9

Tolbutamide

100

159.8

156.8

-1.9

Urea

500

162.8

175.8

8.0

Cholesterol

500

157.7

169.0

7.2

TG

3000

153.7

162.0

5.4

Glactose

50

163.0

157.7

-3.3

Xylose

10

163.0

163.7

0.4

Maltose

300

163.0

155.3

-4.7

Alternative-Site Blood Glucose Measurement

Alternate site testing (AST) for glucose testing is an attractive, nearly painless alternative to the more painful fingertip site. The term alternate site testing (AST) means using parts of the body other than the finger tips to obtain blood for blood glucose testing. Blood glucose values from both sites are virtually equal at metabolic steady state. Unfortunately, due to rapid blood glucose changes, transient but clinically relevant differences between alternate site blood glucose and the fingertip blood glucose occur. During rapid blood glucose changes, the alternate site blood glucose lags behind the fingertip blood glucose by >30 min on average. As a result, the detection of hyperglycemia as well as hypoglycemia can be delayed.

Procedure:

To test the accuracy of the Infinity Automatic Coding Blood Glucose Monitoring System using AST, individuals participated in a study at three clinical sites. The participants were each provided with an Infinity Automatic Coding Blood Glucose Monitoring System labeled and packaged as it would be for the United States market in English. The testers were given sufficient time to read and understand instructions and the contents of the Infinity® system (on their own). Participants did not receive additional training, other instruction, assistance, or training material.

The individuals performed their own finger sticks and test themselves using Infinity® Automatic Coding Blood Glucose Monitoring System without supervision other than that necessary to insure that accurate results were properly recorded. The AST study participants were then asked to perform glucose tests on various test sites. First, participants measured the glucose using Infinity® following instruction for use with their finger’s capillary whole blood. Subsequently, the participants vigorously rubbed their arm (Upper arm or forearm) or Leg (calf or thigh) or palm (ventral palm or dorsal hand) as indicated on the data table, until they felt warming in the area for 5 to 10 seconds. The participants tested themselves using the Lancet device and procedures as indicated in the respective package inserts to collect the samples and to obtain the glucose levels using the Infinity® Automatic Coding Blood Glucose Monitoring System.The participants recorded their own glucose levels on a data sheet. Within five minutes of the participants collecting and testing their own sample, a healthcare professional collected capillary whole blood samples from participants’ finger-stick and a whole blood sample was collect in a capillary anticoagulant tube, centrifuged and then testing serum one time with Hitachi 747.

Conclusion:

Results from all AST sites (dorsal hand, ventral palm, upper arm, forearm, calf, and thigh) are all in the clinically acceptable range compared to traditional finger-tip results.

DATA RESULTS

Figure 1. Linear regression with Palm results vs. Finger results.

Test Range 65 ~ 477 mg/dL
sample No = 100
data No = 100

Test Range 69 ~ 482 mg/dL
sample No = 102
data No = 102

Test Range 65 ~ 482 mg/dL
sample No = 202
data No = 202

Figure 2. Linear regression with Arm results vs Finger results.

Test Range 64 ~ 480 mg/dL
sample No = 100
data No = 100

Test Range 65 ~ 471 mg/dL
sample No = 100
data No = 100

Test Range 64 ~ 480 mg/dL
sample No = 200
data No = 200

Figure 3. Linear regression with Leg results vs Finger results

Test Range 64 ~ 477 mg/dL
sample No = 100
data No = 100

Test Range 65 ~ 471 mg/dL
sample No = 100
data No = 10

Test Range 64 ~ 477 mg/dL
sample No = 200
data No =200

ACCEPATANCE CRITERIA

The minimum acceptable accuracy for G5 INFINITY® results at finger vs. G5 INFINITY® results at AST site shall be as follows.

95% of the individual glucose results shall fall within ±15 mg/dL of the results of the manufacturer's measurement procedure at glucose concentration <75mg/dL and within 20% at glucose concentration (≥75mg/dL)

DATA ANALYSIS

Table 1. Data analysis with finger capillary blood and palm blood

G5 INFINITY®(DORSAL HAND) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

5/5 (100 %)

5/5(100 %)

5/5(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

64/95(67%)

90/95(95%)

94/95(99%)

95/95(100%)

 

G5 INFINITY®(VENTRAL PALM) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

4/5 (80 %)

5/5(100 %)

5/5(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

65/97(67%)

90/97(93%)

94/97(97%)

96/97(99%)

 

G5 INFINITY®(PALM) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

9/10 (90 %)

10/10(96 %)

10/10(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

133/192(67%)

186/192(94%)

194/192(98%)

197/192(99%)

Table 2. Data analysis with finger capillary blood and arm blood

G5 INFINITY®(FOREARM) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

5/6 (83 %)

6/6(100 %)

6/6(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

62/94(66%)

78/94(83%)

92/94(98%)

93/94(99%)

 

G5 INFINITY®(UPPERARM) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

6/7 (86 %)

7/7(100 %)

7/7(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

66/93(71%)

84/93(90%)

92/93(99%)

92/93(99%)

 

G5 INFINITY®(ARM) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

11/13 (85 %)

13/13(100 %)

13/13(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

128/187(68%)

162/187(87%)

184/187(98%)

185/187(99%)

Table 3. Data analysis with finger capillary blood and leg blood


G5 INFINITY®(CALF) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

4/6 (67 %)

6/6(100 %)

6/6(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

59/94(63%)

85/94(90%)

92/94(98%)

92/94(98%)

 

G5 INFINITY®(THIGH) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

6/8 (75 %)

8/8(100 %)

8/8(100%)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

57/92(62%)

81/92(88%)

89/92(97%)

91/92(99%)

 

G5 INFINITY®( LEG) vs. G5 INFINITY®(FINGER)

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)

Within ± 5mg/dL

Within ± 10 mg/dL

Within ± 15mg/dL

(within ± 0.28 mmol/L)

(within ± 0.56 mmol/L)

(within ± 0.83 mmol/L)

10/14(71%)

14/14(100 %)

14/14(100 %)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)

Within ±5%

Within ±10%

Within ±15%

Within ±20%

116/186(62%)

166/186(89%)

181/186(97%)

183/186(98%)

Infinity® Blood Glucose Monitoring System

Features:

  • Automatic coding
  • Convenient strip ejector
  • Fast results in 5 seconds
  • Download results to your PC
  • Alternate site testing
  • Biosensor technology
  • 365 test memory
  • 7 – 90 day averaging
  • Capillary action

Infinity® Blood Glucose Meter Kit

Product Number:

G5-103MK

Contents:

  • Infinity® Meter
  • Control Solution (Normal)
  • Carrying Case
  • Log Book
  • Quick Reference Guide
  • 2 CR 2032 Batteries

Infinity® Blood Glucose Value Pack

Product Number:

G5-003SK

Contents:

  • Infinity® Meter
  • Control Solution (Normal)
  • 10 Infinity® Test Strips
  • 10 Lancets
  • Lancing Device
  • Carrying Case
  • Log Book
  • Quick Reference Guide
  • 2 CR 2032 Batteries
Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
10305 08463-5103-01 885502 001003 4.5 x 2.125 x 6.125 4 9.125 x 5 x 6.25
00305 08463-5003-01 885502 000006 4.5 x 2.125 x 6.125 4 9.125 x 5 x 6.25

Infinity® Test Strips

Features:

  • Small sample size (0.5 µl)
  • Easy-to-use
  • Capillary action
  • For use with Infinity® Meters only

Infinity® Test Strips 50/box

Product Number:

G5-203S50

Content:

50 test strips

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
20351 08463-5203-50 885502 002000 2.75 x 1.43 x 2.8 24 8.75 x 5.75 x 6.5

Clinical Accuracy Testing Data

The accuracy of the EASYGLUCO™ PLUS System was assessed by comparing blood glucose results obtained by patients with those obtained using the Hitachi Glucose Auto analyzer 747, a laboratory instrument. Glucose levels were measured by 160 diabetic patients at three different clinical centers during a month.

Some modified capillary blood samples with glucose concentration of <50mg/dL and >400mg/dL were used.

-To obtain samples with glucose <50mg/dL, capillary blood samples should be collected with an capillary anticoagulant tube and incubated to allow glucose to hydrolyses and adjust at human temperature.

-To obtain samples with glucose >400mg/dL, capillary blood samples should be collected with an capillary anticoagulant tube. The glucose was supplemented and then incubated at human temperature.

First, the user measures the glucose using EASYGLUCO™ PLUS following instructions for use individually two times with two EASYGLUCO™ PLUS meters.

Second, a healthcare professional gathers user’s capillary whole blood in the capillary anticoagulant tube by user’s skin puncture.

This capillary whole blood was centrifuged, and then this plasma’s glucose was measured by the HITACHI 747.

Some modified capillary blood samples in very low glucose (< 50mg/dL) or very high glucose range (>400mg/dL) gather in the capillary anticoagulant tube. After above pretreatment, capillary whole blood glucose was measured by EASYGLUCO™ PLUS.

This capillary whole blood was centrifuged, and then this plasma’s glucose was measured by the HITACHI 747.

Users’ hematocrit value were measured with NOVA system and we select and analyze data with 20~60 % hematocrit based on instruction.

Test condition>

Temperature 23~25 oC
Strip Lot #

 

1 S3IC07A03
2 S3IC07A17
3 S3IC07A20
* At least ten vials were used.

 

Meter S/N

 

1 G24AAHGA00001
2 G24AAHGA00002
3 G24AAHGA00003
4 G24AAHGA00004
5 G24AAHGA00005
6 G24AAHGA00006

 

DATA RESULTS

Figure 1: Linear regression of the 160 blood glucose samples with the Hitachi 747 vs. G5 INFINITY™ System at the Clinical Centers.

Test Range 38 ~ 496 mg/dL
sample No = 160
data No = 320

 

Table 1. Glucose concentration of sample for system accuracy evaluation

glucose concentration (mg/dL) percentage of sample sample #
< 50 5% 8
50 to 80 15% 24
80 to 120 20% 32
120 to 200 30% 48
201 to 300 15% 24
301 to 400 10% 16
> 400 5% 8
SUM 100% 160

 

ACCEPTANCE CRITERIA

The minimum acceptable accuracy for EASYGLUCO™ PLUS results vs. Hitachi 747 shall be as follows. 95% of the individual glucose results shall fall within ±15 mg/dL of the results of the manufacturer's measurement procedure at glucose concentration <75mg/dL and within 20% at glucose concentration (≥75mg/dL)

 

DATA ANALYSIS

System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)
Within ± 5mg/dL Within ± 10 mg/dL Within ± 15mg/dL
(within ± 0.28 mmol/L) (within ± 0.56 mmol/L) (within ± 0.83 mmol/L)
43/56 (77 %) 56/56(100 %) 56/56(100 %)

 

System accuracy results for glucose concentration ≥75 mg/dL (4.2 mmol/L)
Within ±5% Within ±10% Within ±15% Within ±20%
149/264(56%) 224/264(85%) 251/264(95%) 262/264(99%)

 

CONCLUSION

It suggests that the accuracy shows a fine correlation between Hitachi 747 and the G5 INFINITY™ System with the correlation of R2 = 0.9832. As a result, the data shown indicates that the results like within the accuracy standard of ISO15197 and is within acceptance criteria.

RESULT: PASSED Accuracy Test

EasyGluco™ Plus G7 Blood Glucose Monitoring System

Features:

  • LED backlight
  • Automatic coding
  • Convenient strip ejector
  • Fast results in 5 seconds
  • Download results to your PC
  • Alternate site testing
  • Biosensor technology
  • 365+ test memory
  • 7 – 90 day averaging
  • Capillary action

EasyGluco® Plus G7 Blood Glucose Meter Kit

Product Number:

IGM-G7-103

Contents:

meter & solution

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
10302 08463-8103-01 885502001195 4.9375 x 2.125 x 6.25 4 8.75 x 5.375 x 6.875

EasyGluco® Plus G7 Starter Kit

Product Number:

IGM-G7-101

Contents:

meter, 10 strips, 10 lancets, lancing device, control solution

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
00302 08463-8003-01 885502000198 4.9375 x 2.125 x 6.25 4 8.75 x 5.375 x 6.875

Easy Gluco Plus G7 Test Strips

Features:

EasyGluco® Plus G7 Strips 50/box

Product Number:

IGM-G7-203

Contents:

50 test strips

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
20351 08463-9203-50 885502002192 2.3125 x 1.375 x 3.1875 24 8.75 x 5.375 x 6.875

Clinical Accuracy Testing Data

The accuracy of the CONTROL® System was assessed by comparing blood glucose results obtained by patients with those obtained using the Hitachi Glucose Autoanalyzer 747, a laboratory instrument. Glucose levels were measured on 68 and 425 fresh capillary blood specimens by 104 diabetic patients and three healthcare professionals at three different clinical centers.

A fine and direct correlation between Hitachi 747 and CONTROL® were confirmed in the 410 blood samples with the correlation coefficient R=0.9797 and the 104 patients with the correlation coefficient R=0.9782 (Fig. 1 and Fig. 2 respectively). The results indicate that the use of the CONTROL® System generates similar results as the Hitatchi Glucose Autoanalyzer, a laboratory instrument used in hospitals to test for glucose concentration. It also suggests that the fine correlation between the two devices lie within the accuracy standards of the NCCLS.

Figure 1: Linear regression of the 410 blood glucose samples with the Hitachi 747 Vs. CONTROL®
System at the Clinical Centers.

Obtained by Healthcare Professionals in Clinical Centers

Slope:

0.9865

y-intercept:

0.8342

Correlation coefficient(r):

0.9797

No. of samples:

410

Range tested:

68-425mg/dL

Figure 2: Linear regression of the 104 diabetic patients – Hitachi 747 Vs. CONTROL® System

Obtained by Lay diabetics

Slope:

0.9974

y-intercept:

-0.2309

Correlation coefficient(r):

0.9782

No. of samples:

104

Range tested:

85-430mg/dL

The study done by the Clinical centers resulted in 100% of the tested specimens, in region marked A, had glucose values that deviated from the reference method of less than 20% or are less than 70 mg/dL by both methods. As a result, the error grid indicates an excellent accuracy standard in obtaining the concentration of glucose with the CONTROL® System. (Fig. 3 & Table 1)

Figure 3: Error Grid Analysis – Hitachi 747 Vs. CONTROL®

Obtained by Healthcare Professionals in Clinical Centers

Table 8: Summary of Error Grid Analysis Results

Zone

Number

%

A

408

100

B

2

0

C

-

0

D

-

0

E

-

0

Total

410

100

Zone A = clinically accurate, leading to correct treatment decisions

Zone B = deviation from the reference by more than 20%, leading to benign or no treatment.

Zone C = over-correcting of acceptable blood glucose levels.

Zone D = represent a potentially dangerous failure to detect and treat glucose levels outside the desired target range.

Zone E = represents results that would lead to an erroneous treatment.

The study done with the lay diabetics resulted in 99% of the tested subjects, in region marked A, had glucose values that deviated from the reference method of less than 20% or are less than 70 mg/dL mg/dL by both methods. As a result, the error grid indicates an excellent accuracy standard in obtaining
the concentration of glucose with the CONTROL® System. (Fig. 4 & Table 2).

Figure 4: Error Grid Analysis – Hitachi 747 Vs. CONTROL®

Obtained by Lay Diabetics


Table 9: Summary of Error Grid Analysis Results

Zone

Number

%

A

103

99

B

1

1

C

-

0

D

-

0

E

-

0

Total

104

100

Zone A = clinically accurate, leading to correct treatment decisions

Zone B = deviation from the reference by more than 20%, leading to benign or no treatment.

Zone C = over-correcting of acceptable blood glucose levels.

Zone D = represent a potentially dangerous failure to detect and treat glucose levels outside the desired target range.

Zone E = represents results that would lead to an erroneous treatment.

In conclusion, it suggests that the accuracy shows a fine correlation between Hitachi 747 and the CONTROL® System with the correlation of R = 0.9797. As a result, the data shown indicates that the results like within the accuracy standard of NCCLS.

Control® Blood Glucose Monitoring System

Features:

  • Fast results in 5 seconds
  • Download results to your PC
  • Alternate site testing
  • Biosensor technology
  • 250+ test memory
  • 14 day averaging
  • Capillary action
  • 5,000 tests battery life

Control® Blood Glucose Meter Kit

Product Number:

IGM-G3-103

Contents:

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
10302 08463-3103-01 885502001041 4.9375 x 2.125 x 6.25 4 8.75 x 5.375 x 6.875

Control® Starter Kit

Product Number:

IGM-G3-101

Contents:

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
00302 08463-3003-01 885502000044 4.9375 x 2.125 x 6.25 4 8.75 x 5.375 x 6.875

Control® Test Strips

Features:

The Control® Test Strip automatically draws blood into the test strip, and shows you if there is enough blood for an accurate reading.

Control® Test Strips 50/box

Product Number:

IGM-G3-203

Content

50 test strips

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
20351 08463-3203-50 885502002048 2.3125 x 1.375 x 3.1875 24 8.75 x 5.375 x 6.875

Accuracy

The accuracy of the EASYGLUCO™ System was assessed by comparing blood glucose results obtained by patients with those obtained using the Hitachi Glucose Autoanalyzer 747, a laboratory instrument. Glucose levels were measured on 416 and 104 fresh capillary blood specimens by 104 diabetic patients and three healthcare professionals at three different clinical centers.

A fine and direct correlation between Hitachi 747 and EASYGLUCO™ were confirmed in the 416 blood samples with the correlation coefficient R=0.979 and the 104 patients with the correlation coefficient R=0.978 (Fig. 1 and Fig. 2 respectively). The results indicate that the use of the EASYGLUCO™ System generates similar results as the Hitatchi Glucose Autoanalyzer, a laboratory instrument used in hospitals to test for glucose concentration. It also suggests that the fine correlation between the two devices lie within the accuracy standards of the NCCLS.

Obtained by Healthcare Professionals in Clinical Centers

Slope:

0.957

y-intercept:

5.4

Correlation coefficient(r):

0.979

No. of samples:

416

Range tested:

68-430mg/dL

Figure 1: Linear regression of the 416 blood glucose samples with the Hitachi 747 Vs. EASYGLUCO™ System at the Clinical Centers.

Obtained by Lay diabetics

Slope:

0.917

y-intercept:

12.1

Correlation coefficient(r):

0.978

No. of samples:

104

Range tested:

81-425mg/dL

Figure 2: Linear regression of the 104 diabetic patients – Hitachi 747 Vs. EASYGLUCO® System

The study done by the Clinical centers resulted in 98% of the tested specimens, in region marked A, had glucose values that deviated from the reference method of less than 20% or are less than 70 mg/dL by both methods. As a result, the error grid indicates an excellent accuracy standard in obtaining the concentration of glucose with the EASYGLUCO® System. (Fig. 3 & Table 8)

Obtained by Healthcare Professionals in Clinical Centers

Figure 3: Error Grid Analysis – Hitachi 747 Vs. EASYGLUCO®

Table 8: Summary of Error Grid Analysis Results

Zone

Number

%

A

408

98

B

8

2

C

-

0

D

-

0

E

-

0

Total

416

100

Zone A = clinically accurate, leading to correct treatment decisions

Zone B = deviation from the reference by more than 20%, leading to benign or no treatment.

Zone C = over-correcting of acceptable blood glucose levels.

Zone D = represent a potentially dangerous failure to detect and treat glucose levels outside the desired target range.

Zone E = represents results that would lead to an erroneous treatment.

The study done with the lay diabetics resulted in 96% of the tested subjects, in region marked A, had glucose values that deviated from the reference method of less than 20% or are less than 70 mg/dL by both methods. As a result, the error grid indicates an excellent accuracy standard in obtaining the concentration of glucose with the EASYGLUCO® System. (Fig. 4 & Table 9).

Obtained by Lay Diabetics

Figure 4: Error Grid Analysis – Hitachi 747 Vs. EASYGLUCO®

Table 9: Summary of Error Grid Analysis Results

Zone

Number

%

A

100

96

B

4

4

C

-

0

D

-

0

E

-

0

Total

104

100

Zone A = clinically accurate, leading to correct treatment decisions

Zone B = deviation from the reference by more than 20%, leading to benign or no treatment.

Zone C = over-correcting of acceptable blood glucose levels.

Zone D = represent a potentially dangerous failure to detect and treat glucose levels outside the desired target range.

Zone E = represents results that would lead to an erroneous treatment.

In conclusion, the clinical test result of the EASYGLUCO® System suggests that the precision satisfies, in terms of CV percentage for both normal and high solutions, the 10% standard limit from ADA (American Diabetes Association) and CAP Q-Probes study on Bedside Glucose Monitoring. It also suggests that the accuracy shows a fine correlation between Hitachi 747 and the EASYGLUCO® System with the correlation of R = 0.979. As a result, the data shown indicates that the results like within the accuracy standard of NCCLS.

EasyGluco® Blood Glucose Monitoring System

Features:

EasyGluco® Blood Glucose Meter Kit

Product Number:

IGM-G2-103

Contents:

meter & solution

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
10302 08463-0103-01 885502001034 4.9375 x 2.125 x 6.25 4 8.75 x 5.375 x 6.875

EasyGluco® Starter Kit

Product Number:

IGM-G2-101

Contents:

meter, 10 strips, 10 lancets, lancing device, control solution

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
00302 08463-0003-01 885502000037 4.9375 x 2.125 x 6.25 4 8.75 x 5.375 x 6.875

EasyGluco® Strips

Features:

EasyGluco® Strips (50 ct)

Product Number:

IGM--203

Contents:

50 test strips

Cat. No. NDC/HRIC No. UPC No. Unit Size (LxWxH) Case Qty. Case Size (LxWxH)
20351 08463-0203-50 885502002031 2.625 x 1.625 x 2.875 24 8.5 x 7.125 x 6.5