Table 3.

Accuracy Results of the Completely Assessable 34 of 43 Blood Glucose Systems^a

		DIN EN ISO 15197:2003									Current draft revision of ISO 15197
				BG concentration <75 mg/dl			BG concentration ≥75 mg/dl						BG concentration <100 mg/dl			BG concentration ≥100 mg/dl
BG system	Reference method	Within accuracy limits (±15 mg/dl and ±20%)		±15 mg/dl	±10 mg/dl	±5 mg/dl	±20%	±15%	±10%	±5%	Within accuracy limits (±15 mg/dl and ±15%)		±15 mg/dl	±10 mg/dl	±5 mg/dl	±15%	±10%	±5%
		n	%	%	%	%	%	%	%	%	n	%	%	%	%	%	%	%
Accu-Chek Active	HK	(200/200)	100.0	100	100	61	100	100	100	81	(200/200)	100.0	100	100	72	100	100	79
Accu-Chek Aviva	HK	(200/200)	100.0	100	100	87	100	99	91	64	(198/200)	99.0	100	97	80	99	91	64
Accu-Chek Aviva Nano	HK	(200/200)	100.0	100	100	84	100	99	94	65	(199/200)	99.5	100	96	80	99	95	65
Accu-Chek Compact Plus	HK	(200/200)	100.0	100	88	23	100	100	91	63	(200/200)	100.0	100	86	27	100	94	69
Accu-Chek Go	HK	(200/200)	100.0	100	100	97	100	100	97	78	(200/200)	100.0	100	100	94	100	96	79
Accu-Chek Mobileb	HK	(199/200)	99.5	98	98	75	100	100	97	67	(199/200)	99.5	98	98	73	100	96	66
Accu-Chek Mobileb	HK	(200/200)	100.0	100	100	78	100	100	93	64	(200/200)	100.0	100	98	71	100	94	66
Accu-Chek Performab	HK	(199/200)	99.5	100	100	79	99	99	93	67	(199/200)	99.5	100	95	72	99	94	68
Accu-Chek Performab	HK	(198/200)	99.0	100	98	75	99	98	93	68	(196/200)	98.0	98	97	78	98	92	66
Accu-Chek Performa Nano	HK	(200/200)	100.0	100	100	93	100	100	96	66	(200/200)	100.0	100	98	87	100	96	64
Bayer Contour usb	GOx	(194/200)	97.0	100	84	61	96	88	63	31	(182/200)	91.0	90	69	45	91	68	34
Beurer GL32	GOx	(192/200)	96.0	80	48	30	100	98	90	56	(189/200)	94.5	85	62	40	99	91	56
Beurer GL40	GOx	(198/200)	99.0	97	95	53	99	94	78	43	(192/200)	96.0	98	90	52	95	78	42
Biocheck TD-4225	GOx	(187/200)	93.5	73	40	13	99	96	81	48	(183/200)	91.5	76	52	22	97	80	49
FreeStyle Freedom Lite	GOx	(200/200)	100.0	100	100	98	100	100	98	91	(200/200)	100.0	100	100	98	100	98	90
FreeStyle Lite	GOx	(200/200)	100.0	100	100	95	100	100	100	86	(200/200)	100.0	100	100	93	100	100	86
Futura Monometer	GOx	(182/200)	91.0	93	75	23	91	78	59	28	(165/200)	82.5	90	68	27	79	59	26
GlucoCheck Classic	GOx	(191/200)	95.5	100	93	60	94	86	66	38	(177/200)	88.5	97	84	55	85	66	38
GlucoCheck XL	GOx	(191/200)	95.5	98	95	63	95	89	67	40	(182/200)	91.0	97	92	58	88	65	40
Glucohexal IIc	GOx	(162/200)	81.0	61	24	8	86	74	57	28	(143/200)	71.5	50	21	7	80	64	32
GlucoRx (TD-4230)	GOx	(170/200)	85.0	98	45	13	82	63	38	14	(141/200)	70.5	83	41	14	65	40	14
GlucoSmart Swing	GOx	(193/200)	96.5	95	63	24	97	88	60	28	(182/200)	91.0	84	53	15	94	67	33
GlucoTel	GOx	(190/200)	95.0	87	71	37	97	93	70	40	(183/200)	91.5	89	70	33	92	72	41
Gluco-test Plus+ TD-4230	GOx	(198/200)	99.0	100	98	75	99	94	80	45	(190/200)	95.0	96	94	76	95	79	42
iDia	GOx	(191/200)	95.5	100	85	50	94	90	70	41	(184/200)	92.0	96	80	47	90	71	40
IME-DC Fidelity	GOx	(183/200)	91.5	80	48	18	94	88	78	44	(175/200)	87.5	72	43	18	94	85	48
iXell	GOxd	(199/200)	99.5	100	100	70	99	91	77	42	(185/200)	92.5	100	98	68	89	75	38
iXell OLED	GOxd	(198/200)	99.0	95	78	45	100	98	81	42	(194/200)	97.0	97	85	52	97	79	39
microdot+	GOx	(198/200)	99.0	97	97	71	99	94	81	43	(190/200)	95.0	98	95	62	94	83	43
OneTouch Verio	GOx	(199/200)	99.5	100	87	34	99	96	90	62	(198/200)	99.0	97	78	40	100	95	64
OneTouch Verio Pro	GOx	(193/200)	96.5	93	63	20	98	90	70	38	(183/200)	91.5	88	53	21	93	75	40
Pura	HK	(200/200)	100.0	100	92	55	100	100	75	30	(200/200)	100.0	100	95	48	100	74	30
SeniorLine GM210	GOx	(144/200)	72.0	10	0	0	88	72	48	26	(120/200)	60.0	15	0	0	79	55	29
Wellion CALLA Light	GOx	(182/200)	91.0	68	33	10	97	85	68	48	(165/200)	82.5	68	33	13	89	73	52

^a200 results from 100 subjects were evaluated.

^bAccu-Chek Mobile and Accu-Chek Performa were both tested with different test strip chemistries. The test strip chemistry was either maltose dependent (test strips evaluated first) or maltose independent (test strips evaluated second).

^cGlucoHexal test strip lot was recalled from the market in June 2010, after at least 11 months availability on the market.

^dInformation was not available.