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Control™ Blood Glucose Monitoring
System
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The Control™ Meter makes managing
your diabetes Easy. The Control™ Meter
gives you accurate and reliable results
in just 5 seconds and it only requires 1ul
of blood, a tiny sample size. You can now
test your blood glucose from your forearm,
thigh, calf, palm, as well as your fingertips.
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Features:
• Alternate Site Testing
• Biosensor Technology
• Results in 5 Seconds
• Tiny Sample Size (1ul)
• Blood Applied, Capillary Action, Automatic start
• Easy, Simple, and Accurate
• 14 Days Plus Averaging
• 250+ Test Memory
• 5,000 Tests Battery Life (vs. 1,000 for some
of the other leading brands)
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Product
Comparison
Substantial Equivalence Information
This device is an in vitro diagnostic product intended
for the measurement of glucose concentration in human
blood for diabetics. The principle of the test relies
upon a specific type of glucose in the blood sample,
the dehydrogenase glucose that reacts to electrodes
in the test strip. The test strip employs an electrochemical
signal generating an electrical current that will stimulate
a chemical reaction. This reaction is measured
by the Meter and displayed as your blood glucose result.
Note: Different levels of reactions will occur with
the amount of glucose in the bloodsample.
The technological characteristics of the CONTROL™
in comparison to OneTouch® Ultra®:
The modified CONTROL™ device has the same technological
characteristics as the ONE TOUCH® Ultra®.
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CONTROL™
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ONE TOUCH® Ultra®
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Detection method
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Amperometry: current is generated
by oxidation of reduced mediator. |
Amperometry |
| Enzyme |
Glucose Oxidase (Aspergillus
niger) |
Glucose Oxidase (Aspergillus niger)
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| Mediator |
Hexaammineruthenium chloride |
Potassium ferricyanide |
| Electrode |
Carbon electrode |
Carbon electrode |
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The other ingredients of test strip, such as enzyme
stabilizer, buffer and binder are different.
The CONTROL™ Blood Glucose Monitoring System
provides the same glucose monitoring capability as the
predicate device, the ONE TOUCH® Ultra®.
The primary differences are in the advanced memory function
and battery lifetime.
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CONTROL™
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ONE TOUCH® Ultra®
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| Test range |
10 ~ 600 mg/dL |
20 ~ 600 mg/dL |
| Hematocrit Range |
30 ~55% |
30 ~ 55% |
| Test Time |
5 seconds |
5 seconds |
| Sample Volume |
1uL |
1uL |
| Temperature & Humidity range |
50 ~ 104o F
10 ~ 40o C
10 ~ 90%
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43 ~ 111o F
6 ~ 44o C
10 ~ 90%
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| Open use time |
3 months |
3 months |
| Coding |
Button (C1 ~C45) |
Button (C1 ~ C49) |
| Memory capability |
From 7 to 99-day average and 250 tests in the
memory |
14-day average and last 150 tests in the memory |
| Power |
3V Li battery (CR2032) |
3V Li battery (CR2032) |
| Battery life |
Running 5,000 test |
Running 1,000 test |
| Size: LxWxH (mm) |
91x54.5x22.8 |
79x57x21 |
| Weight |
55g(with battery) |
42g (with battery) |
| Warranty |
Lifetime |
3 years |
| Software |
CONTROL TM diabetes management software |
IN TOUCH® diabetes management software |
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CONTROL™ |
ONE TOUCH® UltraTM
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SURESTEP® |
| Precision |
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Within-run
(venous blood) |
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40.2
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1.8
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4.4
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93.6
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3.0
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3.3
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131.4
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5.0
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3.8
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202.8
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7.4
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3.7
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321.4
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5.0
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1.5
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45
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1.4
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3.2
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77
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1.5
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2.0
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129
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2.7
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2.1
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220
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4.0
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1.8
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364
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5.8
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1.6
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83.4
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3.0
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3.6
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210
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8.2
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3.8
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467.7
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14.3
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3.1
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| Between-run/Total (control solution) |
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51.3
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1.1
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2.2
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121
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3.2
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2.7
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330.1
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11.4
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3.5
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| Accuracy |
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Slope
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y-intercept
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Correlation coefficient®
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No. of samples
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Range tested
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0.9865
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0.83 mg/dL
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0.979
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410
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68~425 mg/dL
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*0.986
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-5.5 mg/dL
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0.984
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117
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36.4~434 mg/dL
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**0.977
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-1.9 mg/dL
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0.969
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268
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62~468 mg/dL
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* At 3 clinical centers. A YSI Model
2300 glucose analyzer, a laboratory instrument was used.
** At 4 different U.S. sites from 134 participants with
diabetes, each performing 2 meter tests. A YSI Model
2700 glucose analyzer, a laboratory instrument was used.
Non-clinical: Verification,
validation and testing activities were conducted to
establish the performance, functionality and reliability
characteristics of the CONTROL™ Blood Glucose
Monitoring System with respect to the predicate device.
Testing involved the verification of software requirement
specifications, product requirement specifications and
user interface requirement specifications from risk
analysis. Pass or fail criteria were based on the specification
cleared for the predicate device and results showed
substantial equivalence.
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DIABETIC TESTING SUPPLIES
