Comparison of a few glucose meter with their ISO 15197 version 2003 and 2013 published studies.

1. Blood Glucose
Monitoring
Systems
Editorial
Rating
DIN EN ISO 15197: 2003 DIN EN ISO 15197: 2013
References
Within Accuracy limits
(+- 15 mg/dl and +- 20%)
BG concentration < 75
mg/dl
BG concentration >= 75 mg/dl
Within Accuracy limits
(+- 15 mg/dl and +- 15%)
BG concentration < 100
mg/dl
BG concentration >=
100 mg/dl
+- 15
mg/dl
+- 10
mg/dl
+- 5
mg/dl
+-
20%
+-
15%
+-
10%
+- 5%
+- 15
mg/dl
+- 10
mg/dl
+- 5
mg/dl
+-
15%
+-
10%
+-
5%
n % % % % % % % % n % % % % % % %
Abbott FreeStyle
Lite 9
(178/179) 99.4-100 100 100
72.7-
79.3
99.4-
100
98.8-
99.5
92.5-
95.2
67.7-
68.5
FDA
doc(k092602)
(294/301) 97.7 100 83.3 59.5 97.3 88.4 61.4 [1] Third Party
(200/200) 100.0 100 100 95 100 100 100 86 (200/200) 100.0 100 100 93 100 100 86 [2]
Sponsored by
Roche
(799/800) 99.5-100 100 84-100 58-95
99-
100
86-
100
66-
100
34-86 (779/800) 89.5-100 100 86-100 59-93
85-
100
63-
100
31-
86
[3]
Sponsored by
Roche
(474/480) 99 100 94 63 99 97 93 68 (471/480) 98 98 92 67 98 93 69 [4]
Sponsored by
Abbott
Abbott FreeStyle
Freedom Lite
8.5
(178/179) 99.4-100 100 100
72.7-
79.3
99.4-
100
98.8-
99.5
92.5-
95.2
67.7-
68.5
FDA
doc(k092602)
(204/208) 98.1 97.6 97.6 81.0 97.7 94.0 86.8 59.0 [5]
Sponsored by
Sanofi
(200/200) 100.0 100 100 98 100 100 98 91 (200/200) 100.0 100 100 98 100 98 90 [2]
Sponsored by
Roche
(187/200) 93.5 83 95 [6]
Sponsored by
Nipro
(476/480) 98 90 87 58 98 96 90 63 (466/488) 95 94 91 61 96 89 63 [4]
Sponsored by
Abbott
Abbott FreeStyle
Flash
8.5 (150/150) 100 100 100
60-
100
100 98-99 83-86 52-57
FDA
doc(k092638)
Abbott Precision
Xtra
7 (178/183) 97.4-99.4
FDA doc
(k070984)
WaveSense Jazz 8 (178/180) 98.8 100 75 39 99 94 78 45 (173/180) 96.1 100 75 38 95 80 47 [2]
Sponsored by
Roche
WaveSense
Presto
8 (96/96) 100 100 96.4 64.3 100 97.2 93.3 57.3 [7]
Performed by
Agamatrix
Bayer Contour 6
(204/211) 96.7 97.6 87.8 53.7 96.5 93.5 78.2 44.7 [5]
Sponsored by
Sanofi
(471/501) 92 93 70 45 92 84 66 38 (439/510) 94 96 72 41 94 82 49 [4]
Sponsored by
Abbott
(71/74) 96.6 100 88.6 [8]
Performed by
Bayer
Bayer Contour
USB
6
(194/200) 97.0 100 84 61 96 88 63 31 (182/200) 91.0 90 69 45 91 68 34 [2]
Sponsored by
Roche
(228/238) 95.8 100 84.8 57.6 95.1 82.9 49.8 [1] Third-party
Bayer Ascensia
Contour
6
(189/200) 94.5 89 95 [6]
Sponsored by
Nipro
(106/106) 100 100 100 91.7 100 97.6 82.9 48.7
FDA
doc(k060470)

2. Recently Updated on Dec 19, 2013
Bayer Contour
Next USB
9 (522/522) 100 100 100 83.3 100 100 98.1 74.7
FDA doc
(k121087)
Bayer Breeze 2 6 No information
OneTouch Ultra2 6
(188/198) 94.9 94 95 [6]
Sponsored by
Nipro
(207/212) 97.6 97.6 97.6 78.6 97.7 91.2 80.6 50.0 [5]
Sponsored by
Sanofi
(578/600) 96.3 100 84.5 48.8 95.7 88.2 68.0 38.0
OneTouch User
Manual
OneTouch
UltraSmart
6 (578/600) 96.3 100 84.5 48.8 95.7 88.2 68.0 38.0
OneTouch User
Manual
OneTouch
UltraMini
6 (578/600) 96.3 100 84.5 48.8 95.7 88.2 68.0 38.0
OneTouch User
Manual
OneTouch Verio
IQ
7
(245/265) 92.5 84.0 68.0 36.0 93.3 78.8 57.9 [1] Third-party
(199/200) 99.5 100 87 34 99 96 90 62 (198/200) 99.0 97 78 40 100 95 64 [2]
Sponsored by
Roche
(600/600) 99.2 100 100 86.3 100 97.8 93.4 71.9
FDA doc
(K110637)
Accu-Chek
Compact Plus
9
(200/200) 100.0 100 88 23 100 100 91 63 (200/200) 100.0 100 86 27 100 94 69 [2]
Sponsored by
Roche
(100/100) 100.0 100 100 58-95 100 100
99-
100
84-89
FDA doc
(K113614)
Accu-Chek Aviva
Plus
8.5 (298/300) 99.3 100 100
75-
93.8
98.8-
100
96.4-
98.8
86.9-
89.3
52.4-
63.1
FDA doc
(k101299)
Accu-Chek Aviva
8
(207/212) 100 97.7 92.9 64.3 97.1 91.8 77.1 48.2 [5]
Sponsored by
Sanofi
(489/504) 97 95 80 33 97 93 80 48 (475/504) 94 96 72 41 94 82 49 [4]
Sponsored by
Abbott
(200/200) 100.0 100 100 87 100 99 91 64 (198/200) 99.0 100 97 80 99 91 64 [2]
Sponsored by
Roche
(800/800) 100.0 100 98-100 83-97 100
99-
100
91-99 64-71 (798/800)
99.0-
100.0
100 97-100 78-95
99-
100
91-
99
64-
68
[3]
Sponsored by
Roche
Accu-Chek Nano
SmartView
9
(294/303) 97.0 91.4 77.1 45.7 97.8 87.3 56.0 [1] Third-party
(200/200) 100.0 100 100 84 100 99 94 65 (199/200) 99.5 100 96 80 99 95 65 [2]
Sponsored by
Roche
iBGStar 6.5
(208/212) 98.1 100 92.9 50.0 97.7 96.5 81.8 40.0 [5]
Sponsored by
Sanofi
(173/180) 96.1 100 93 57 95 90 74 36 (165/180) 91.6 96 90 52 90 72 35 [2]
Sponsored by
Roche
(100/100) 100 100 100 65 100 99 92 67
FDA doc
(k103544)

3. References
1. Hasslacher, C., F. Kulozik, and I. Platten, Accuracy of self monitoring blood glucose systems in a clinical setting: application of new planned ISO- standards. Clinical Laboratory, 2012. 59(7-8): p. 727-33.
2. Freckmann, G., et al., System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197. Journal of Diabetes Science and Technology, 2012. 6(5): p.
1060-1075.
3. Baumstark, A., et al., Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197. Journal of Diabetes Science and Technology, 2012. 6(5).
4. Tack, C., et al., Accuracy Evaluation of Five Blood Glucose Monitoring Systems Obtained from the Pharmacy: A European Multicenter Study with 453 Subjects. Diabetes Technology & Therapeutics, 2012. 14(4): p. 330–
337.
5. Pfützner, A., et al., Clinical assessment of the accuracy of blood glucose measurement devices. Current Medical Research and Opinion, 2012. 28(4): p. 525-531.
6. Bell, D.E. and T.A. Sasse, Accuracy study of blood glucose monitoring systems: Evaluation of the TRUEresult, OneTouch Ultra2, Ascensia Contour, FreeStyle Freedom Lite.
7. AgaMatrix® White Paper: Performance of the AgaMatrix Presto® Advanced Blood Glucose Monitoring System. 2007.
8. List, S., et al., Performance Evaluation and Labeling Comprehension of a New Blood Glucose Monitoring System with Integrated Information Management. Journal of Diabetes Science and Technology, 2011. 5(5).