Performance Data

Correlation Calibrator and Control

MQ-2000PT(HPLC)
18.0
MQ-2000PT VS. Competitor Sample distribution range Correlation data Product Specification
16.0

Sample Range(%) Percentage Sample Required Sample Qty MQ-2000PT VS.

HbA1c Calibrator (2 levels) 1 test/kit Report
HbA1c Control (2 levels) 1 test/kit
14.0 Model Competitor
4-4.5 5% 10 10
12.0
Y=1.0517X-

Glycated Hemoglobin Analyzer

4.6-6.0 25% 50 61 a
Storage and stability: over 24-month shelf life when unopened at 2-8℃
0.1114 1.0517
10.0
6.1-8.0 25% 50 62
8.0
8.1-10.0 25% 50 68 b -0.1114

6.0
10.1-12.0 15% 30 33
| |
MQ-2000PT

4.0
r 0.9963 PRECISE ACCURATE CONVENIENT
>12.1 5% 10 15
4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0

Reproducibility Stability

Intra-assay Inter-assay
precision(n=20) precision(n=20) QC L H

Mean 5.67 8.74 5.75 9.98 Mean(%) 5.68 9.96

SD 0.0813 0.1046 0.14 0.21 SD 0.08 0.13
CV 1.43 1.20 2.36 2.15 CV(%) 1.41 1.33

Effects of Coexisting Substances Reagent Allocation

Bilirubin • F - 19.7mg/dL COMPOSITION SPECIFICATIONS QUANTITY

Bilirubin • C - 21.0 mg/dL Reagent A 1800ml/bottle 2
Hemolytic hemoglobin - 488 mg/dL Reagent B 1400ml/ bottle 1
Chyle - 1550 FTU Haemotyser 1800ml/ bottle 4
Ascorbic acid - 50 mg/dL Column Unit 1
Glucose - 1200 mg/dL Vials Unit 100
Acetaldehyde - 60 mg/dL Paper rolls roll 6

No interference from coexisting substances up to above concentrations Filter 400T 2

* 800 tests for each pack of reagent

4 - month open stability at 4 - 30 ℃
18 - month shelf life when unopened at 4 - 30 ℃

Manufactures:
Shanghai Medconn Medical Technology Co., Ltd. (Instrument)
Shanghai Medconn Biotechnology Co., Ltd. (Reagent)
Beijing Medconn Medical Devices Co., Ltd. (Calibrator & Control)
 MQ-2000PT(HPLC) Automatic HbA1c Analyzer

Company Profile
Global Leading HPLC Principle Performance Characteristics
Specifications
HPLC is recognized as a‘Gold Standard’for HbA1c test · Automatic identify the sample type (whole blood/diluted
because of its high sensitivity and stable performance. blood)

· Loading capacity up to 50 samples with streamline work Principle Ion exchange chromatography with HPLC principle
· Eliminate unstable HbA1c interferences flow

· Eliminate variant Hb interferences · Cap piercing function

· Automatic sample bar code reading Speed Sample cycle ≤150s/T

· Auto-mixing function
Sample volume whole blood 10 μL

Operation System & Software Cutting-edge Technology

Loading Capacity 50 Samples
· English operational support · High-pressure plunger pump (Micro-pump) ensures a
· Touch-screen utilized constant velocity, avoiding the influence of any resistance

· Data storage > 20000 tests from rest of the chromatographic system
Wave length : 415nm

· Pressure, temperature, test quantity display · 24 AD high-precision detector can detect the absorbance
· With a LIS interface of sample with high-precision and high-resolution
Testing Measuring range (NGSP value): HbA1c 4%-17%, r≥0.99
Shanghai Medconn Medical Technology Co., Ltd.

Precision : CV ≤ 2%
It is specialized in R&D and production of medical instruments. It has been successfully devel-
oped blood gas, HPLC method A1c and chemiluminescence analyzer. The A1c systems are
certified by international academic authorities, including both NGSP and IFCC. International Certification...
Environmental Temperature : 15℃-35℃

Shanghai Medconn Biotechnology Co., Ltd.

Operating Conditions Humidity : ≤80%
√ CE approved product
√ Traceability to IFCC/NGSP
It is specialized in R&D and production of IVD reagents. It has been successfully developed
more than 50 biochemistry reagents to cover wide range of clinical aspects and HPLC principle
HbA1c reagents. Besides traditional products, it also able to provide advanced high sensitive √ ISO qualified organization Barometric Pressure : 79-106kPa

latex based immuno-chemistry reagents.

Voltage: 220V-240V

Beijing Medconn Medical Devices Co., Ltd. Power Requirement

The company was established in December of 2010, mainly focusing in Chemiluminescence Frequency : 50-60HZ

technology development and HbA1c calibrators & controls produce.

610mm*500mm*410mm (L*W*H）

Dimension
MEDCONN is the leading brand in the field of HbA1c testing in China, with more than 3000 customers
worldwide, providing them with FAST, EASY, RELIABLE testing experience. Weight: 29kg
 Performance Data
Correlation Calibrator and Control

MQ-2000PT(HPLC)
18.0
MQ-2000PT VS. Competitor Sample distribution range Correlation data Product Specification
16.0

Sample Range(%) Percentage Sample Required Sample Qty MQ-2000PT VS.

HbA1c Calibrator (2 levels) 1 test/kit Report
HbA1c Control (2 levels) 1 test/kit
14.0 Model Competitor
4-4.5 5% 10 10
12.0
Y=1.0517X-

Glycated Hemoglobin Analyzer

4.6-6.0 25% 50 61 a
Storage and stability: over 24-month shelf life when unopened at 2-8℃
0.1114 1.0517
10.0
6.1-8.0 25% 50 62
8.0
8.1-10.0 25% 50 68 b -0.1114

6.0
10.1-12.0 15% 30 33
| |
MQ-2000PT

4.0
r 0.9963 PRECISE ACCURATE CONVENIENT
>12.1 5% 10 15
4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0

Reproducibility Stability

Intra-assay Inter-assay
precision(n=20) precision(n=20) QC L H

Mean 5.67 8.74 5.75 9.98 Mean(%) 5.68 9.96

SD 0.0813 0.1046 0.14 0.21 SD 0.08 0.13
CV 1.43 1.20 2.36 2.15 CV(%) 1.41 1.33

Effects of Coexisting Substances Reagent Allocation

Bilirubin • F - 19.7mg/dL COMPOSITION SPECIFICATIONS QUANTITY

Bilirubin • C - 21.0 mg/dL Reagent A 1800ml/bottle 2
Hemolytic hemoglobin - 488 mg/dL Reagent B 1400ml/ bottle 1
Chyle - 1550 FTU Haemotyser 1800ml/ bottle 4
Ascorbic acid - 50 mg/dL Column Unit 1
Glucose - 1200 mg/dL Vials Unit 100
Acetaldehyde - 60 mg/dL Paper rolls roll 6

No interference from coexisting substances up to above concentrations Filter 400T 2

* 800 tests for each pack of reagent

4 - month open stability at 4 - 30 ℃
20- month shelf life when unopened at 4 - 30 ℃

Manufactures:
Shanghai Medconn Medical Technology Co., Ltd. (Instrument)
Shanghai Medconn Biotechnology Co., Ltd. (Reagent)
Beijing Medconn Medical Devices Co., Ltd. (Calibrator & Control)
 Performance Data
Correlation Calibrator and Control

MQ-2000PT(HPLC)
18.0
MQ-2000PT VS. Competitor Sample distribution range Correlation data Product Specification
16.0

Sample Range(%) Percentage Sample Required Sample Qty MQ-2000PT VS.

HbA1c Calibrator (2 levels) 1 test/kit Report
HbA1c Control (2 levels) 0.5ml/kit
14.0 Model Competitor
4-4.5 5% 10 10
12.0
Y=1.0517X-

Glycated Hemoglobin Analyzer

4.6-6.0 25% 50 61 a
Storage and stability: over 24-month shelf life when unopened at 2-8℃
0.1114 1.0517
10.0
6.1-8.0 25% 50 62
8.0
8.1-10.0 25% 50 68 b -0.1114

6.0
10.1-12.0 15% 30 33
| |
MQ-2000PT

4.0
r 0.9963 PRECISE ACCURATE CONVENIENT
>12.1 5% 10 15
4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0

Reproducibility Stability

Intra-assay Inter-assay
precision(n=20) precision(n=20) QC L H

Mean 5.67 8.74 5.75 9.98 Mean(%) 5.68 9.96

SD 0.0813 0.1046 0.14 0.21 SD 0.08 0.13
CV 1.43 1.20 2.36 2.15 CV(%) 1.41 1.33

Effects of Coexisting Substances Reagent Allocation

Bilirubin • F - 19.7mg/dL COMPOSITION SPECIFICATIONS QUANTITY

Bilirubin • C - 21.0 mg/dL Reagent A 1800ml/bottle 2
Hemolytic hemoglobin - 488 mg/dL Reagent B 1400ml/ bottle 1
Chyle - 1550 FTU Haemotyser 1800ml/ bottle 4
Ascorbic acid - 50 mg/dL Column Unit 1
Glucose - 1200 mg/dL Vials Unit 100
Acetaldehyde - 60 mg/dL Paper rolls roll 6

No interference from coexisting substances up to above concentrations Filter 400T 2

* 800 tests for each pack of reagent

4 - month open stability at 4 - 30 ℃
18 - month shelf life when unopened at 4 - 30 ℃

Manufactures:
Shanghai Medconn Medical Technology Co., Ltd. (Instrument)
Shanghai Medconn Biotechnology Co., Ltd. (Reagent)
Beijing Medconn Medical Devices Co., Ltd. (Calibrator & Control)
 MQ-2000PT(HPLC) Automatic HbA1c Analyzer

Company Profile
Global Leading HPLC Principle Performance Characteristics
Specifications
HPLC is recognized as a‘Gold Standard’for HbA1c test · Automatic identify the sample type (whole blood/diluted
because of its high sensitivity and stable performance. blood)

· Loading capacity up to 50 samples with streamline work Principle Ion exchange chromatography with HPLC principle
· Eliminate unstable HbA1c interferences flow

· Eliminate variant Hb interferences · Cap piercing function

· Automatic sample bar code reading Speed Sample cycle ≤150s/T

· Auto-mixing function
Sample volume whole blood 10 μL

Operation System & Software Cutting-edge Technology

Loading Capacity 50 Samples
· English operational support · High-pressure plunger pump (Micro-pump) ensures a
· Touch-screen utilized constant velocity, avoiding the influence of any resistance

· Data storage > 20000 tests from rest of the chromatographic system
Wave length : 415nm

· Pressure, temperature, test quantity display · 24 AD high-precision detector can detect the absorbance
· With a LIS interface of sample with high-precision and high-resolution
Testing Measuring range (NGSP value): HbA1c 4%-17%, r≥0.99
Shanghai Medconn Medical Technology Co., Ltd.

Precision : CV ≤ 2%
It is specialized in R&D and production of medical instruments. It has been successfully devel-
oped blood gas, HPLC method A1c and chemiluminescence analyzer. The A1c systems are
certified by international academic authorities, including both NGSP and IFCC. International Certification...
Environmental Temperature : 15℃-35℃

Shanghai Medconn Biotechnology Co., Ltd.

Operating Conditions Humidity : ≤80%
√ CE approved product
√ Traceability to IFCC/NGSP
It is specialized in R&D and production of IVD reagents. It has been successfully developed
more than 50 biochemistry reagents to cover wide range of clinical aspects and HPLC principle
HbA1c reagents. Besides traditional products, it also able to provide advanced high sensitive √ ISO qualified organization Barometric Pressure : 79-106kPa

latex based immuno-chemistry reagents.

Voltage: 220V-240V

Beijing Medconn Medical Devices Co., Ltd. Power Requirement

The company was established in December of 2010, mainly focusing in Chemiluminescence Frequency : 50-60HZ

technology development and HbA1c calibrators & controls produce.

610mm*500mm*410mm (L*W*H）

Dimension
MEDCONN is the leading brand in the field of HbA1c testing in China, with more than 3000 customers
worldwide, providing them with FAST, EASY, RELIABLE testing experience. Weight: 29kg
 MQ-2000PT(HPLC) Automatic HbA1c Analyzer

Company Profile
Global Leading HPLC Principle Performance Characteristics
Specifications
HPLC is recognized as a‘Gold Standard’for HbA1c test · Automatic identify the sample type (whole blood/diluted
because of its high sensitivity and stable performance. blood)

· Loading capacity up to 50 samples with streamline work Principle Ion exchange chromatography with HPLC principle
· Eliminate unstable HbA1c interferences flow

· Eliminate variant Hb interferences · Cap piercing function

· Automatic sample bar code reading Speed Sample cycle ≤150s/T

· Auto-mixing function
Sample volume whole blood 10 μL

Operation System & Software Cutting-edge Technology

Loading Capacity 50 Samples
· English operational support · High-pressure plunger pump (Micro-pump) ensures a
· Touch-screen utilized constant velocity, avoiding the influence of any resistance

· Data storage > 20000 tests from rest of the chromatographic system
Wave length : 415nm

· Pressure, temperature, test quantity display · 24 AD high-precision detector can detect the absorbance
· With a LIS interface of sample with high-precision and high-resolution
Testing Measuring range (NGSP value): HbA1c 4%-17%, r≥0.99
Shanghai Medconn Medical Technology Co., Ltd.

Precision : CV ≤ 2%
It is specialized in R&D and production of medical instruments. It has been successfully devel-
oped blood gas, HPLC method A1c and chemiluminescence analyzer. The A1c systems are
certified by international academic authorities, including both NGSP and IFCC. International Certification...
Environmental Temperature : 15℃-35℃

Shanghai Medconn Biotechnology Co., Ltd.

Operating Conditions Humidity : ≤80%
√ CE approved product
√ Traceability to IFCC/NGSP
It is specialized in R&D and production of IVD reagents. It has been successfully developed
more than 50 biochemistry reagents to cover wide range of clinical aspects and HPLC principle
HbA1c reagents. Besides traditional products, it also able to provide advanced high sensitive √ ISO qualified organization Barometric Pressure : 79-106kPa

latex based immuno-chemistry reagents.

Voltage: 220V-240V

Beijing Medconn Medical Devices Co., Ltd. Power Requirement

The company was established in December of 2010, mainly focusing in Chemiluminescence Frequency : 50-60HZ

technology development and HbA1c calibrators & controls produce.

610mm*500mm*410mm (L*W*H）

Dimension
MEDCONN is the leading brand in the field of HbA1c testing in China, with more than 3000 customers
worldwide, providing them with FAST, EASY, RELIABLE testing experience. Weight: 29kg