Evaluation Report: Accu-Chek® Performa Test Strips

with Advanced Chemistry

Accu-Chek® Performa test strips provide

accurate and reliable blood glucose measurements.
Now compliant with the performance requirements
of ISO 15197:2013

SUMMARY

The Accu-Chek Performa test strips with advanced chemistry have undergone a wide range
of testing, including studies at external sites and extensive internal testing. Test results
demonstrate the test strips provide accurate and reliable blood glucose measurements under
varied conditions including the presence of maltose, and are compliant with the performance
requirements of ISO 15197: 2013. The Accu-Chek Performa test strips can be used with
the Accu‑Chek Performa, Accu-Chek Performa Combo, Accu-Chek Performa Connect,
Accu‑Chek Performa Insight, and Accu-Chek Performa Nano meters.

This document describes the Accu-Chek Performa system and summarizes the test results for
studies of accuracy, precision, hematocrit and interfering substances.
Introduction
The Accu-Chek Performa system serves as an accurate, reliable, and easy-to-use tool for monitoring
blood glucose levels. The Accu-Chek Performa meter and test strips with advanced chemistry provide
people with diabetes with a reliable, 5-second test with proven sample sufficiency detection, wide
hematocrit and environmental ranges, and a minimal sample volume of 0.6 µL. Additionally, the system
delivers accurate results with alternative sites, such as the palm and forearm, thereby allowing people
with diabetes to test with less pain.
The Accu-Chek Performa system performs extensive quality checks with every test, enabling it to
protect against factors such as temperature and hematocrit that can cause errors or inaccurate results
in other systems. The system’s advanced chemistry also provides accurate test results in the presence of
maltose, making it suitable for use by:
• people receiving therapy with solutions containing maltose, which is present in some
immunoglobulin preparations, and
• people on peritoneal dialysis using solutions containing icodextrin, such as EXTRANEAL™ dialysis
solution.
This document summarizes test results for the Accu-Chek Performa system. Test results for this
system are representative of test results for the following systems: Accu-Chek Performa Combo,
Accu‑Chek Performa Connect, Accu-Chek Performa Insight, and Accu-Chek Performa Nano.


Accu-Chek Performa System Specifications
The table below indicates the specifications for the Accu-Chek Performa meter and test strips with
advanced chemistry.
Table 1. System Specifications

Category Accu-Chek Performa System Specification

Measurement principle Mutant variant of quinoprotein glucose dehydrogenase
(Mut. Q‑GDH), electrochemical
Range of measurement 10 to 600 mg/dL
Measuring time 5 seconds
Operating temperature 8°C to 44°C (46°F to 111°F)
Operating humidity 10 to 90%
Sample volume 0.6 µL
Hematocrit range 10 to 65%
Altitude Up to 3,094 meters (10,150 feet) above sea level
Sample types Capillary, venous, arterial, neonatal
Test sites Fingertip, palm (thenar and hypothenar), forearm,
upper arm
Support and safety functions • Automatic recognition and flagging of control solutions
• Out-of-box date and time setting
• Backup battery for date and time


Accu-Chek Performa System Technology
With its patented technology, the Accu-Chek Performa system gathers and analyzes extensive
information to calculate a blood glucose measurement. Benefits of the technology include:
• Accurate and efficient temperature estimation. The Accu-Chek Performa meter measures
the temperature of the reaction zone on the test strip rather than relying on an internal thermistor.
Therefore, the meter can accurately and efficiently compensate for temperature influences at the
sample application site.
• Compensation for hematocrit effects. The Accu-Chek Performa meter is able to compensate
for hematocrit influences within a broad hematocrit range (10 to 65%).
• Sample sufficiency detection. Sample application is detected on one set of electrodes and
adequate sample volume on another set. This feature helps prevent the user from underdosing a
test strip and obtaining a potentially inaccurate result.
• Automatic recognition of Accu-Chek Performa control solutions. The system can
automatically distinguish quality control solutions from blood.
• Quality checks. The Accu-Chek Performa meter conducts extensive quality checks with every
test, including sample, strip, and system checks.
Meter Support and Safety Functions
• Out-of-box time and date setting. The Accu-Chek Performa meter is shipped with the battery
already inserted. The factory-set time and date can be confirmed with a simple button press,
thereby minimizing meter setup time.
• Backup battery for time and date. A backup battery is housed in the meter to help preserve
time and date information in the event that the main battery is no longer available. This feature
ensures that the meter can provide accurate time stamps on results.


Accu-Chek Performa Test Strip with Advanced Chemistry
Strip Architecture and Functionality
The Accu-Chek Performa test strip with advanced chemistry contains six electrodes (see Figure 1) that
allow the system, along with its patented technology, to perform extensive quality checks. The following
quality checks ensure that the user obtains an accurate result:
• Sample checks
 Verify whether the correct amount of blood is applied
 Detect and identify the sample as blood or a control solution
• System checks
 Detect humidity exposure
 Detect variations in temperature
• Strip checks
 Evaluate the test strips and reagent for potential damage or abuse, including:
 exposure to high humidity
 scratches on the strip electrodes

Figure 1. Accu-Chek Performa Test Strip with Advanced Chemistry

Easy-fill tip quickly and easily

absorbs blood sample

Wide sample area simplifies

blood application

Strip Reaction Principle

The enzyme on the Accu-Chek Performa test strip with advanced chemistry, Mut. Q-GDH from
Acinetobacter calcoaceticus, recombinant in E. coli, converts the glucose in the blood sample to
gluconolactone. This reaction creates a harmless DC electrical current that the meter interprets for
blood glucose. The sample and environmental conditions are also evaluated using a small AC signal.


Accuracy Studies Using the Accu-Chek Performa System
Accuracy with Capillary Whole Blood
A study was conducted to assess the accuracy of the Accu-Chek Performa system with capillary blood
samples. Technicians at a participating facility performed capillary finger sticks on 100 patients. Two
glucose test strips from three individual strip lots were dosed for each subject, for a total of 200 glucose
meter results per lot. These results were compared to whole blood reference samples, which were
analyzed on a Roche analyzer using glucose hexokinase methodology and mathematically converted to
IFCC plasma-like reference values. The glucose reference values ranged from 12 to 525 mg/dL, and the
hematocrit range tested was 33-46%.
Results of the study were assessed per the following acceptance criteria:
• 95% of the individual glucose results shall fall within ±15 mg/dL of the reference results at
glucose concentrations less than 100 mg/dL and within ±15% at glucose concentrations greater
than or equal to 100 mg/dL.
• For the combined results from the three lots tested, 99% of individual glucose measured values
shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.
Each of the lots tested met the acceptance criteria. The data for all three strip lots are presented in
Figure 2 as a bias plot and summarized in Table 2. As seen in Figure 2 and Table 2, 99.2% of the data
were within these bias requirements and the acceptance criteria were clearly met. In addition, at least
99% of the values were within zones A and B of the Consensus Error Grid. These data indicate that the
Accu-Chek Performa system provides accurate results with capillary blood samples and meets ISO
15197:2013 requirements1.

1 International Organization for Standardization (ISO) 15197:2013. In vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus


 Figure 2. Accuracy with Capillary Whole Blood

150
130 5 Outliers = (0.8 %) 95% CI (0.3, 1.9)
Mean Bias = 3 95% CI (2.6, 3.4)
110 SD = 4.6
N=600
90 Med Abs Bias = 3.3
70
50
30
Bias (mg/dL)

10
-10
-30
-50
-70
-90
-110
-130
-150
0 50 100 150 200 250 300 350 400 450 500 550 600
Plasma Like Reference (mg/dL)

Table 2. Accuracy with Capillary Whole Blood

Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL

Results <100 mg/dL 137/168 163/168 167/168

(81.5%) (97.0%) (99.4%)
Within ±5% Within ±10% Within ±15%

Results ≥100 mg/dL 256/432 393/432 428/432

(59.3%) (91.0%) (99.1%)


Accuracy with Capillary Whole Blood Performed by Patients
Patients at two facilities were asked to read the labeling provided with the Accu-Chek Performa system,
and to subsequently perform a finger stick and dose a test strip from one of the three independent
strip lots. The patients were given no instruction by a trained technician. The subject’s results were
compared to whole blood reference samples, which were analyzed on a Roche analyzer using glucose
hexokinase methodology and mathematically converted to IFCC plasma-like reference values. Data from
207 patients were used in the analysis. The glucose reference values ranged from 41 to 412 mg/dL, and
the hematocrit range tested was 26 to 54%.
The results for all three strip lots, analyzed by linear regression, are presented in Figure 3. The graph
shows strong correlation between the subject’s finger stick results and the reference method (0.988),
indicating minimal scatter around the regression line. These data demonstrate that the untrained user
can obtain accurate results with capillary blood, and results meet ISO 15197:2013 requirements.

Figure 3. Accuracy with Capillary Whole Blood – Performed by Patients

600
Y=0.978 X + 1
550 Correlation = 0.988
R Square = 0.976
500 Std. Error = 10.5
Intercept CI (-2.6, 4.6)
Subject Capillary Glucose Results (mg/dL)

Slope CI (0.956, 1)
450 N=207
Ref. Range 41 - 412
400
350
300
250
200
150
100
50
0
0 50 100 150 200 250 300 350 400 450 500 550 600
Plasma Like Reference (mg/dL)


Accuracy with Venous Whole Blood
Technicians at one clinical site collected blood via venipuncture. Test strips from three independent lots
were then dosed with the venous blood samples by the technicians. These results were compared to
whole blood reference samples, which were analyzed on a Roche/Hitachi 917 analyzer using glucose
hexokinase methodology and mathematically converted to IFCC plasma-like reference values. Data from
209 patients were used in the analysis. The glucose reference values ranged from 54 to 557 mg/dL, and
the hematocrit range tested was 28 to 59%.
The results for one representative strip lot, analyzed by linear regression, are presented in Figure 4.
The graph illustrates good correlation to the reference method (0.994) and a small standard error (8.6),
indicating minimal scatter around the regression line. These data confirm that the Accu-Chek Performa
system provides accurate results with venous blood samples.

Figure 4. Accuracy with Venous Whole Blood

600
Y=1.048 X + -2.5
550 Correlation = 0.994
R Square = 0.989
500 Std. Error = 8.6
Intercept CI (-5.3, 0.3)
Venous Glucose Results (mg/dL)

450 Slope CI (1.032, 1.064)

N=209
400
350
300
250
200
150
100
50
0
0 50 100 150 200 250 300 350 400 450 500 550 600
Plasma Like Reference (mg/dL)


Accuracy with Neonatal Capillary Whole Blood
Studies were conducted to assess the accuracy of the Accu-Chek Performa system with neonatal
capillary blood samples. Technicians at a participating facility performed capillary heelsticks on
newborns (less than 30 days old) and dosed test strips from three independent strip lots. These results
were compared to whole blood reference samples, which were analyzed on a Roche/Hitachi 917
analyzer using glucose hexokinase methodology and mathematically converted to IFCC plasma‑like
reference values. Data from 211 patients were used in the analysis. The glucose reference values
ranged from 11 to 359 mg/dL and the hematocrit range tested was 24 to 65%.
The results for one representative strip lot, analyzed by linear regression, are presented in Figure 5. The
graph shows good correlation to the reference method (0.993), and a very small standard error (3.6),
indicating minimal scatter around the regression line. These data indicate that the Accu-Chek Performa
system provides accurate results with neonatal whole blood samples.
To further demonstrate accuracy with capillary neonate blood at glucose concentrations less than
50 mg/dL, additional analysis was performed on three independent strip lots using heelstick blood
samples from 37 neonates. Table 3 shows the pooled bias of the individual capillary heelstick samples
with a glucose concentration less than 50 mg/dL. As shown, the Accu-Chek Performa system provides
accurate results with neonatal whole blood samples at glucose levels less than 50 mg/dL.

Figure 5. Accuracy with Neonatal Capillary Whole Blood

400
Y=1.012 X + 0
Correlation = 0.993
Neonate Capillary Glucose Results (mg/dL)

350 R Square = 0.986

Std. Error = 3.6
Intercept CI (-1.2, 1.2)
300 Slope CI (0.996, 1.028)
N=211

250

200

150

100

50

0
0 50 100 150 200 250 300 350 400
Plasma Like Reference (mg/dL)

Table 3. Pooled Lot Bias for Neonate Capillary Samples Under 50 mg/dL Glucose

N Mean Bias (mg/dL)

Results <50 mg/dL 111 1.2

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Accuracy with Arterial Whole Blood
Technicians at one clinical site collected arterial blood using their standard operating procedure. Test
strips from three independent lots were then dosed with the arterial blood samples by the technicians.
These results were compared to whole blood reference samples, which were analyzed on a
Roche/Hitachi 917 analyzer using glucose hexokinase methodology and mathematically converted
to IFCC plasma-like reference values. Data from 211 patients were used in the analysis. The glucose
reference values ranged from 76 to 420 mg/dL and the hematocrit range tested was 13 to 48%.
The results for one representative strip lot, analyzed by linear regression, are presented in Figure 6. The
graph illustrates good correlation to the reference method (0.991) and a standard error of 7.1, indicating
minimal scatter around the regression line. As shown, the Accu-Chek Performa system provides
accurate results with arterial blood samples.

Figure 6. Accuracy with Arterial Whole Blood

600
Y=1.026 X + -1.9
550 Correlation = 0.991
R Square = 0.983
500 Std. Error = 7.1
Intercept CI (-4.8, 1)
Arterial Glucose Results (mg/dL)

450 Slope CI (1.008, 1.044)

N=211
400
350
300
250
200
150
100
50
0
0 50 100 150 200 250 300 350 400 450 500 550 600
Plasma Like Reference (mg/dL)

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Accuracy at Elevated Altitude
Testing occurred at one clinical facility located 3,094 meters (10,150 feet) above sea level. A trained
technician performed a capillary finger stick on each patient and dosed three test strips, each from a
different strip lot. These results were compared to whole blood reference samples, which were analyzed
on a Roche/Hitachi 917 analyzer using glucose hexokinase methodology and mathematically converted
to IFCC plasma-like reference values. Data from 94 patients were used in the analysis. The glucose
reference values ranged from 63 to 468 mg/dL, and the hematocrit range tested was 34 to 62%.
In Figure 7, the data for all three strip lots are presented in a bias plot and assessed per the following
acceptance criteria:
• 95% of the individual glucose results shall fall within ±15 mg/dL of the reference results at
glucose concentrations less than 100 mg/dL and within ±15% at glucose concentrations
greater than or equal to 100 mg/dL.
As seen in Figure 7, 98.6% of the data were within these bias requirements and the acceptance criteria
were clearly met. These data indicate that the Accu-Chek Performa system provides accurate results at
elevated altitude.

Figure 7. Accuracy at Elevated Altitude

180 4 Outliers = (1.4 %)

160 Mean Bias = -3.8
140 SD = 7.1
N=280
120 Med Abs Bias = 5
100 95% CI (0.4, 3.6)
95% CI (-4.6, -2.9)
80
60
Bias (mg/dL)

40
20
0
-20
-40
-60
-80
-100
-120
-140
-160
-180
0 50 100 150 200 250 300 350 400 450 500 550 600
Plasma Like Reference (mg/dL)

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Accuracy with Alternative Site Testing (AST)
Multiple test sites are commonly used as an alternative to the finger, including palm (thenar and
hypothenar), forearm, and upper arm. A total of 390 subjects at three clinical facilities performed
alternative site testing, including palm thenar, palm hypothenar, forearm, and upper arm. The studies
were conducted using one lot of Accu-Chek Performa test strips. Only data from patients that met the
study protocol inclusion criteria and steady state inclusion criteria were included in the analysis. (Steady
state, as described in the Accu-Chek Performa product labeling, is defined as having no intake of food
or insulin within two hours of testing.)
Subjects performed testing from the alternate site. These results were compared to whole blood
reference samples (obtained from a capillary finger stick), which were analyzed on a Roche/Hitachi 917
analyzer using glucose hexokinase methodology and mathematically converted to IFCC plasma-like
reference values.
Figure 8 and Figure 9 show the data for two representative sites, palm thenar and forearm testing,
respectively. A total of 148 results were used for the palm thenar comparison and 127 results were used
for the forearm comparison. The results are presented as bias plots and assessed per the following
acceptance criteria:
• 95% of the individual glucose results shall fall within ±15 mg/dL of the reference results
at glucose concentrations less than 75 mg/dL and within ±20% at glucose concentrations
greater than or equal to 75 mg/dL.
As seen in Figure 8 and Figure 9, 98.6% of the data for palm thenar testing and 96.9% of the data for
forearm testing were within these bias requirements and the acceptance criteria were clearly met.
These data demonstrate that the Accu-Chek Performa system provides accurate results with alternative
site samples for subjects meeting the inclusion criteria.

13
 Figure 8. Accuracy with Alternative Site Testing – Palm Thenar

150
125 2 Outliers = (1.4 %) 95% CI (0.2, 4.8)
Mean Bias = -0.6 95% CI (-2, 0.8)
100 SD = 8.6
N=148
75 Med Abs Bias = 5.8

50
Bias (mg/dL)

25
0
-25
-50
-75
-100
-125
-150
0 50 100 150 200 250 300 350 400 450 500 550 600
Plasma Like Reference (mg/dL)

Figure 9. Accuracy with Alternative Site Testing – Forearm

150
125 4 Outliers = (3.1 %) 95% CI (0.9, 7.9)
Mean Bias = 1.1 95% CI (-0.5, 2.7)
100 SD = 9.3
N=127
75 Med Abs Bias = 5.5
50
Bias (mg/dL)

25
0
-25
-50
-75
-100
-125
-150
0 50 100 150 200 250 300 350 400 450 500 550 600
Plasma Like Reference (mg/dL)

14
Accu-Chek Performa System Precision
The precision of the Accu-Chek Performa system was assessed using both aqueous control solutions
and venous blood samples. For aqueous control solutions, ten vials of test strips from each of three
lots were allocated per level. For venous blood samples, fifty vials of test strips from each of three lots
were allocated per level. Ten replicates per vial were collected and the overall SD or CV was calculated
(based on glucose level).
The following control levels were used in the precision studies:
• Low: 30 to 60 mg/dL
• Mid: 98 to 132 mg/dL
• High: 254 to 344 mg/dL
The following spiked venous blood levels were used in the precision studies:
• 1: 30 to 50 mg/dL
• 2: 51 to 110 mg/dL
• 3: 111 to 150 mg/dL
• 4: 151 to 250 mg/dL
• 5: 251 to 400 mg/dL
Table 4 and Table 5 show the results of precision testing with controls, and Table 6 and Table 7 show
results of precision testing with blood. Acceptable performance is defined as:
• At glucose concentrations less than or equal to 100 mg/dL, a standard deviation (SD) of less than
or equal to 5 mg/dL
• At glucose concentrations greater than or equal to 100 mg/dL, a coefficient of variance (CV) less
than or equal to 5%.
Results show that all precision estimates for control and spiked venous blood are below the
5 mg/dL or 5% threshold. In fact, for both controls and venous blood with all strip lots pooled, all SD
values at glucose levels below 100 mg/dL are 3.2 mg/dL or below, and all CV values for glucose levels
100 mg/dL and above are 3.9% or below. These data indicate that the Accu-Chek Performa system
provides precise results with both control solutions and whole blood, and meets ISO 15197:2013
requirements.

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Table 4. System Precision (Day-to-Day) – Control Solutions, Individual Strip Lots

Level Low Mid High

Strip Lot 1 2 3 1 2 3 1 2 3
N 100 100 100 100 100 100 100 100 100
Mean (mg/dL) 45.5 45.6 45.8 118.2 118.9 118.8 310.4 310.5 310.8
SD (mg/dL) 1.1 1.2 1.5 2.5 2.9 2.7 5.6 6.7 6.6
CV (%) – – – 2.1 2.4 2.3 1.8 2.1 2.1

Table 5. System Precision (Day-to-Day) – Control Solutions, Pooled Strip Lots

Level Low Mid High

N 300 300 300
Mean (mg/dL) 45.6 118.6 310.6
Variance 1.6 7.3 39.5
SD (mg/dL) 1.3 2.7 6.3
CV (%) – 2.3 2.0

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Table 6. System Precision (Within-Lot) – Blood, Individual Strip Lots

Level 1 2 3 4 5
Strip Lot 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
N 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
Mean (mg/dL) 42.7 42.7 42.3 89.1 90.7 88.8 121.1 122.4 123.7 184.3 189.4 186.9 309.7 315.1 314.3
SD (mg/dL) 1.6 1.7 1.9 3.0 3.2 3.0 3.8 4.5 4.0 6.7 7.1 7.0 10.2 11.9 11.6
CV (%) – – – – – – 3.2 3.7 3.3 3.6 3.8 3.8 3.3 3.8 3.7

Table 7. System Precision (Within-Lot) – Blood, Pooled Strip Lots

Level 1 2 3 4 5
N 300 300 300 300 300
Mean (mg/dL) 42.6 89.5 122.4 186.9 313.0
Variance 3.0 10.0 18.1 52.2 131.7
SD (mg/dL) 1.7 3.2 4.3 7.2 11.5
CV (%) – – 3.5 3.9 3.7

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Impact of Hematocrit
Three levels of glycolized venous blood with the target glucose level at 40, 120, and 350 mg/dL were
tested with hematocrit levels adjusted to 10, 30, 55, and 65% to determine the impact of hematocrit
on the performance of the Accu-Chek Performa system. These results were compared to a sample at
nominal hematocrit (42%).
Three strip lots were tested and all lots met the following acceptance criteria:
• The mean bias (to reference glucose) obtained with samples with glucose levels less than
100 mg/dL, shall not exceed ±10 mg/dL bias to the nominal hematocrit sample (42%) mean bias
(to reference glucose), and
• The mean bias (to reference glucose) obtained with samples with glucose levels greater than or
equal to 100 mg/dL, shall not exceed ±10% bias to the nominal hematocrit sample (42%) mean
bias (to reference glucose)
The results for one representative lot are shown in Figure 10. Data from all three lots confirm that
the Accu-Chek Performa system supports a claimed hematocrit range of 10 to 65% and meets
ISO 15197:2013 requirements.

Figure 10. Impact of Hematocrit

20
40mg/dL Glucose
Difference from Mid-Level Hematocrit (mg/dL or %)

120mg/dL Glucose
15
350mg/dL Glucose

10

-5

-10

-15

-20
0 10 20 30 40 50 60 70 80

Hematocrit Level (%)

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Interfering Substances
The Accu-Chek Performa system has been thoroughly evaluated with potential interfering substances.
Substances specified in Annex A of the ISO (International Organization for Standardization) 15197:2013
Standard were tested at concentrations described by the Clinical Lab Standard Institute (CLSI) in
document EP7-A2 — Interference Testing in Clinical Chemistry; Approved Guideline, when available.
Many of the endogenous and exogenous elements were evaluated at strengths three or more times
therapeutic plasma concentrations. Each medication and metabolite was evaluated at the following
targeted glucose levels to ensure accuracy:
• 50 to 100 mg/dL
• 250 to 350 mg/dL
Test results indicate that the system provides accurate results in the presence of the substances tested,
generally well beyond the therapeutic or physiologic range. See Table 8 for a list of the substances
evaluated, along with the concentration tested and the therapeutic or physiologic concentration range
(or upper limit). All concentrations are in terms of mg/dL unless noted otherwise.
Table 8. Potential Interfering Substances – Concentrations Tested

Therapeutic / Physiologic
Substance Concentration Tested (mg/dL) Concentration Range (or Upper
Limit) (mg/dL)
Acetaminophen (paracetamol) 20 1–3
Bilirubin (unconjugated) 40 < 1.1
Cholesterol 500 300
Creatinine 30 1.5
DOPA (L) 2 0.02 – 0.28
Dopamine 0.09 0.03
EDTA (K2) 360 N/A2
Gentisic Acid 1.8 0.2 – 0.6
Glutathione (reduced) 6.14 0.7
Hemoglobin 600 2.5
Heparin (Li) 8000 U/dL 35 – 100 U/dL
Ibuprofen 50 1.0 – 7.0
Maltose 360 0 – 360
Methyl Dopa 1.5 0.1 – 0.75
Pralidoxime Iodide (PAM) 25 8
Salicylic Acid 60 9.94 – 29.95
Tolazamide 200 1.6
Tolbutamide 100 4.3 – 24.0
Uric Acid 23.5 2.3 – 8.0
Xylose 100 30
2
EDTA (K2) is used as an anticoagulant in blood collection tubes.
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The following compounds, when tested with the Accu-Chek Performa system, were found to be
interfering substances.
Table 9. Interfering Substances

Accu-Chek Performa System

Substance
Accuracy Threshold (mg/dL)
Lipidemia (Triglycerides)3 > 1800
Galactose4 > 15
Ascorbic Acid5 >3

3
Lipemic samples (triglycerides) in excess of 1800 mg/dL may produce elevated results.
4
Blood concentrations of galactose greater than 15 mg/dL will cause overestimation of blood glucose results.
5
Intravenous administration of ascorbic acid that results in blood concentrations of ascorbic acid greater than 3 mg/dL will cause overestimation of blood
glucose results.

20
Conclusion

The data presented in this document demonstrate the capability of the Accu-Chek Performa
meter and test strips with advanced chemistry, and indicate that the system is compliant
with the performance requirements of ISO 15197:2013. The system’s 5-second test, wide
hematocrit and environmental ranges, and minimal sample volume make it an easy-to-use tool
for monitoring of blood glucose levels. With every test, the system performs extensive quality
checks to ensure accurate and reliable results. The system’s advanced chemistry also provides
accurate test results in the presence of maltose, which makes it suitable for use by people
receiving therapy with solutions containing or producing maltose.

ACCU-CHEK, ACCU-CHEK PERFORMA, PERFORMA COMBO, PERFORMA CONNECT, PERFORMA INSIGHT, and
PERFORMA NANO are trademarks of Roche. All other product names and trademarks are the property of their
respective owners. © 2014 Roche. PMG-GPE-0814

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