Blood Glucose Test Strips Technical Requirements (Electrochemical)

Medical Device Product Technical Requirements Number: MZ-2025-01

Version: v1.0
Document Code: SOP-14
Effective Date: December 17, 2025

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1. Product Model/Specifications

1.1 Product Model and Explanation

1. Model: GDHFAD Blood Glucose Test Strips
2. Model Designation: "GDH" represents that the product uses Glucose Dehydrogenase as the core detection enzyme, "FAD" represents the specific subtype of the enzyme (such as Flavin Adenine Dinucleotide-dependent type, ensuring reaction specificity), no sub-specifications, all products of this model have consistent core performance and structural composition, only accessory configurations (such as whether spare batteries are included) may vary slightly depending on the sales package.

1.2 Packaging Specifications

25 strips/box, 50 strips/box, 100 strips/box.

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2. Performance Indicators

2.1 Appearance

a) All components are complete, packaging is intact without contamination, labels are undamaged and not peeling; b) Test strips should be smooth without burrs, the sampling area on the front should be clean without stains.

2.2 Blood Glucose Test Strip Repeatability

Blood glucose test strip repeated measurement results precision should meet the requirements of Table 1:

Table 1 Repeatability Requirements

Test Range	Precision
2.2mmol/L ～ 5.5 mmol/L (40 mg/dL ～ 100 mg/dL)	SD＜0.42 mmol/L (＜7.7 mg/dL)
5.5 mmol/L ～ 27.8 mmol/L (100 mg/dL ～ 500 mg/dL)	CV＜7.5%

2.3 Blood Glucose Test Strip Accuracy

Blood glucose test strip measurement accuracy should meet one of the following requirements:

a) 95% of blood glucose test strip measurement result deviations should meet the requirements of Table 2; b) Blood glucose test strip glucose recovery rate is 80%～120%.

Table 2 Accuracy Requirements

Test Range	Allowable Deviation
2.2 mmol/L ～ 4.2 mmol/L (40 mg/dL ～ 75 mg/dL)	Not exceeding ±0.83 mmol/L(±15 mg/dL)
4.2 mmol/L ～ 27.8 mmol/L (75 mg/dL ～ 500 mg/dL)	Not exceeding ±20%

2.4 Blood Glucose Test Strip Batch-to-Batch Difference

Batch-to-batch difference of different batch number blood glucose test strips should not exceed 15%.

2.5 Blood Glucose Test Strip Linear Range

Linear range 2.2 mmol/L～27.8 mmol/L (40 mg/dL～500 mg/dL), correlation coefficient not less than 0.98.

2.6 Blood Glucose Test Strip Stability

Testing blood glucose test strips placed at 45℃ for 1 week should meet 2.2 and 2.3 requirements.

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3. Testing Methods

3.1 Appearance Inspection

Inspect with normal or corrected vision, results should meet 2.1 requirements.

3.2 Blood Glucose Test Strip Repeatability

Testing venous whole blood (replacing fingertip capillary blood)

Referring to "GB/T 19634-2005 In Vitro Diagnostic Testing Systems Self-Testing Blood Glucose Monitoring Systems General Technical Conditions", collect fresh venous whole blood from blood sample providers with hematocrit of 0.35L/L to 0.50L/L (35% to 50%), inject into test tubes with heparin or EDTA anticoagulant, avoiding hemolysis. Place samples at room temperature (23℃±5℃) to equilibrate, bringing sample temperature to room temperature ±2℃, as the temperature at test start. Should use venous whole blood samples with blood glucose concentrations falling in Table 3 for repeatability testing. Each sample should be gently inverted to mix thoroughly before testing. Then repeat testing 20 times on two blood glucose meters according to the manual. Calculate the standard deviation (SD) and coefficient of variation (CV) of results, results should meet 2.2 requirements.

Table 3 Blood Glucose Concentration Range for Repeatability Testing

Blood Glucose Concentration [mmol/L (mg/dL)]
2.2 ～ 2.8(40 ～ 50)
2.9 ～ 6.1(51 ～ 110)
6.2 ～ 8.3(111 ～ 150)
8.4 ～ 13.9(151 ～ 250)
14.0 ～ 22.2(251 ～ 400)

Note: The glucose concentration in venous blood samples can be adjusted with equal parts glucose solution prepared with 0.9% saline. The degree of dilution should not affect the sample matrix. Sufficient preservatives that meet manufacturer recommendations and do not interfere with blood glucose detection (such as: maleimide, fluoride, or iodoacetate solution) should be added to samples to avoid glycolysis. To obtain low glucose concentration blood samples, anticoagulated blood samples can be left overnight to allow glucose concentration to drop to the required level.

3.3 Blood Glucose Test Strip Accuracy

Testing venous blood samples (replacing capillary blood samples)

3.3.1 Comparison Test

Use 50 venous whole blood samples with blood glucose concentration ranges falling in Table 4. Before testing with each sample, gently invert to mix thoroughly. Each venous blood sample is divided into 3 parts, the 1^st part is tested with the 1^st blood glucose meter, the 2^nd part is tested with the 2^nd blood glucose meter, testing should be conducted according to the manual testing procedure; the 3^rd part is centrifuged at high speed, after removing plasma, an analyzer is used for blood glucose testing. The difference between the venous whole blood results \(\bar{y_i}\) tested by each blood glucose meter and the venous whole blood results \(\bar{x_i}\) tested by the analyzer is the deviation, results should meet 2.3 requirements.

Accuracy calculation formula:

Absolute deviation:

\[ {{\bar{x_i}} - {\bar{y_i}}} \text{ ……………………（1）} \]

Relative deviation:

\[ {\frac{{\bar{x_i}} - {\bar{y_i}}}{\bar{x_i}} \times 100\%} \text{ …………… （2）} \]

Table 4 Blood Glucose Concentration Range for Accuracy Testing

Sample Quantity	Blood Glucose Concentration [mmol/L (mg/dL)]
2	＜2.8 (＜50)
8	2.8～4.3 (50～80)
10	4.4～6.7 (81～120)
15	6.7～11.1 (121～200)
8	11.2～16.6 (201～300)
5	16.7～22.2 (301～400)
2	＞22.2 (＞400)

Note: Samples with blood glucose concentration in the range of 2.8mmol/L～22.2mmol/L (50mg/dL～400mg/dL) should be obtained from original samples. Extreme concentration samples at both ends can be obtained by the following methods: Collect blood samples in test tubes with anticoagulant, incubate them in a 37℃ incubator overnight to cause blood glucose glycolysis, obtaining samples with blood glucose concentration < 2.8mmol/L; Collect blood samples in test tubes with anticoagulant, then add appropriate glucose, obtaining samples with blood glucose concentration > 22.2mmol/L.

3.3.2 Recovery Test

Take venous whole blood sample S1 with heparin anticoagulant added, sufficient preservatives that meet manufacturer recommendations and do not interfere with blood glucose detection can be added to samples to avoid glycolysis. Accurately pipette 7 equal portions of S1 with concentration range in Table 4 (volume V1), add V2 (S2), V3 (S3), V4 (S4), V5 (S5), V6 (S6), V7 (S7) standard glucose saline solutions of known concentration to 6 of them respectively, finally making the glucose concentrations of the 7 samples fall within the range of Table 4 respectively. Each sample is gently inverted to mix thoroughly, test the 7 samples 10 times each using 2 blood glucose meters and the same batch number blood glucose test strips, the average of 10 measurements are recorded as C1, C2, C3, C4, C5, C6, C7 respectively. Calculate the glucose recovery rate of the blood glucose meter and blood glucose test strips according to formula (3), test results should meet 2.3 requirements.

\[ R_n= {\frac{{C_i}\times{({V_1}+{V_i})}-{{C_1}\times{V_1}}}{{V_i}\times{C_s}}} {\times{100\%}} \text{ …………… （3）} \]

Where:

• \(R\) — recovery rate
• \(n=1,2,3,4,5,6\)
• \(i=2,3,4,5,6,7\)
• \(V_i\) — volume of glucose saline solution added between samples \(S\) and \(S_i\)
• \(V_1\) — volume of sample \(S_1\)
• \(C_i\) — measured concentration of sample \(S_i\)
• \(C_1\) — measured concentration of sample \(S_1\)
• \(C_s\) — concentration of prepared glucose solution

3.4 Blood Glucose Test Strip Batch-to-Batch Difference

Referring to "GB/T 19634-2005 In Vitro Diagnostic Testing Systems Self-Testing Blood Glucose Monitoring Systems General Technical Conditions", use 3 different batch number blood glucose test strips on the same blood glucose meter to repeatedly measure normal fasting fresh venous whole blood or quality control material 10 times each, calculate the average value of measurement results for the 3 batches respectively, and calculate the overall average value of all 3 batch measurement results, calculate batch-to-batch difference according to formula (4), results should meet 2.4 requirements.

\[ \text{Batch-to-batch difference} = \frac{\text{Maximum average value} - \text{Minimum average value}}{\text{Overall average value}} \times 100\% \text{ ……………………（4）} \]

3.5 Blood Glucose Test Strip Linear Range

Referring to "GB/T 19634-2005 In Vitro Diagnostic Testing Systems Self-Testing Blood Glucose Monitoring Systems General Technical Conditions", take venous whole blood samples with heparin anticoagulant added, finally making 7 samples with glucose concentrations within the range of Table 4 (2-6), with the 1^st and 7^th samples at concentrations of 2.2 mmol/L and 27.8 mmol/L respectively. Divide the prepared samples into two equal parts, one part uses an analyzer for glucose measurement, the other part uses two blood glucose meters and the same batch number blood glucose test strips to test 10 times each. For each test sample, the analyzer test value is xi, the blood glucose meter test value is yi, calculate the correlation coefficient of the two sets of data according to formula (5). Results should meet 2.5 requirements.

\[ r = \frac{\sum_{i=1}^{n}(x_i - \bar{x})(y_i - \bar{y})}{\sqrt{\sum_{i=1}^{n}(x_i - \bar{x})^2 \sum_{i=1}^{n}(y_i - \bar{y})^2}} \text{ ……………………（5）} \]

Where:

• \(r\) — correlation coefficient
• \(n\) — number of samples
• \(x_i\) — analyzer measurement value for the i-th sample
• \(y_i\) — blood glucose meter measurement value for the i-th sample
• \(\bar{x}\) — average value of analyzer measurements
• \(\bar{y}\) — average value of blood glucose meter measurements

3.6 Blood Glucose Test Strip Stability

Dilute 1000 mg/dL standard product with standard dilution solution to 2.8 mmol/L (50 mg/dL) and 16.7 mmol/L (300 mg/dL), divide the prepared samples into two equal parts, one part uses an analyzer for glucose measurement, the other part uses two blood glucose meters to test test strips placed at 45℃ for 1 week respectively, repeat testing 10 times on each blood glucose meter, results should meet 2.6 requirements.

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Document Control: - Prepared by: Quality Assurance Department - Reviewed by: Technical Department - Approved by: General Manager - Effective Date: December 17, 2025 - Version: v1.0