BIOWAY BIOLOGICAL TECHNOLOGY CO.

,LTD

Instrument Performance Evaluation Report

Urine analyzer (dry chemical method)

Model：BW-300 Urine analyzer from Bioway

Digitally signed by Jighili Tatiana

Date: 2021.07.08 13:08:58 EEST
Reason: MoldSign Signature
Location: Moldova
 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD

Content

1．Purpose and content........................................................................................................................... 1

2． Urine analysis test strip determination kit related information.......................................................1

2．1Test equipment .................................................................................................................... 1

2．2 Batch number and specifications............................................................................................. 1

3．Analysis performance evaluation plan................................................................................................ 1

3．1 Working environment conditions......................................................................................... 1

3．2 Appearance ............................................................................................................................. 1

3．3 Loading capacity ..................................................................................................................... 2

3．4 Function .................................................................................................................................. 2

3．5 Accuracy.................................................................................................................................... 2

3．6 Repeatability............................................................................................................................. 3

3．7 Detection limit.......................................................................................................................... 3

3．8 Analylsis specificity ................................................................................................................. 3

3.8.1Anti-interference............................................................................................................... 3

3.8.2Anti-vitamin C interference...............................................................................................4

3．9 Difference between batches.................................................................................................... 4

4． Analyze performance evaluation data and results ......................................................................... 4

4.1Working environment conditions.................................................................................................4

4．2 Appearance............................................................................................................................... 4

4．3 Packing capacity ...................................................................................................................5

4．4 Accuracy.................................................................................................................................... 5

4．5 Repeatability........................................................................................................................... 10

4．7 Analysis specificity.................................................................................................................. 16

4.7.1Anti-interference substance analysis.............................................................................. 16

4.7.2Anti-vitamin C interference.............................................................................................17

4．8 Difference between batches............................................................................................... 19

5．Analysis performance evaluation summary......................................................................................22

6．Analysis performance evaluation conclusion....................................................................................22

 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD

1. Purpose and content

Objective: To evaluate whether the performance indicators of the urine analyzer produced by Bioway

Biological technology Co., Ltd. meet the technical requirements of the products and meet the clinical

needs.

Content: This report submitted the analysis performance evaluation data of urine analysis test paper

(hereinafter referred to as test paper) (dry chemical method), and the performance indicators of the

machine, including working environment, appearance, loading, accuracy, repeatability, and inter-batch

difference The detection limit and analysis specificity were tested separately.

2．Urine analysis test strip determination kit related information

2.1 Experimental instruments

The instrument used for performance evaluation is BIOWAY BW-300 urine analyzer

2.2 Batch number and specifications

Applicable specifications and models of the instrument: URS-10H, URS-11H, URS-12H, URS-14H,

URS-8H, URS-4H

Instrument detection model: URS-14H

The urine analysis test paper model used for performance evaluation is URS-14H, and the batch numbers
are 2019020701, 2019020901 and 2019021101. This product is designed with a variety of packaging
specifications. The test strips of various models are completely the same in terms of raw materials,
production processes, reaction principles, and inspections. The individual tests are relatively independent
and do not interfere with each other. There is no difference in performance on the same item. The
applicable urine analyzer has no effect on the performance evaluation results. Therefore, the test paper
model URS-14H that can cover all the testing items is selected for performance testing.
3. Analysis performance evaluation plan

3.1 Working environment conditions

Temperature 20℃～28℃, relative humidity is not more than 80%

3.2 Appearance

The appearance of the urine test analyzer should meet the following requirements:

(a) The outer surface of the analyzer should be flat, smooth, uniform in color, free from scratches, burrs,

sharp edges, and deformation.

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(b) The text of the analyzer should be clear and easy to recognize;

3.3 Maneuverability

The switches and buttons on the analyzer should be flexible and reliable, easy to operate, the data

cable connection should be firm and reliable, and the actual information should be clear and stable.

3.4 Function

(a) It should be able to start the self-test and identify customs declaration errors

(B) The result unit has at least an international unit system

(C) Should have an output port

(D) It should be able to store test data

(E) The machine should have a correction function

3.5 Accuracy

When the test paper is tested with artificial standard urine at the concentration listed in Table 1,

each test item is measured three times at each specification point, and the difference between the test

result and the reference solution label concentration is calculated, and the test result is different from the

corresponding reference solution label value. No more than one order of magnitude in the same direction,

no reverse phase difference is allowed. Negative results shall not appear in positive reference solutions,

and positive results shall not appear in negative reference solutions.

Table 1 Accuracy test table

Test items Inspection concentration and marked value

Neg ± + ++ +++

LEU（cells/µl） 0 15 70 125 500

NIT（µmol/l） 0 —— 18.12 —— ——

URO（µmol/l） 3.3(±) 16 33 66 133

PRO（g/l） 0 0.15 0.3 1.0 3.0

BLD（cells/µl） 0 10 25 80 200

KET（mmol/l） 0 0.5 1.5 3.9 7.8

VC（mmol/l） 0 0.6 1.4 2.8 5.6

BIL（µmol/l） 0 —— 17 50 100

GLU（mmol/l） 0 5.5 14 28 55

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 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD

CAL（g/l） 0 —— 0.15 0.3 0.5

CRE（g/l） 0 —— 10 20 30

MAL（g/l） 0 —— 0.15 —— ——

pH 5.0、6.0、7.0、8.0、9.0

SG 1.010、1.020、1.030

3.6 Repeatability

Randomly draw 20 test strips of the same batch number, and use any positive artificial standard urine

whose concentration is not less than "+" shown in Appendix A as the test solution to calculate the

consistency of the test results of each test item. The consistency is not less than 90%.

The calculation results are consistent; calculate the results according to formula (1).

V（%）= N/20 ×100% ----------------------- （1）

In the formula：

V：Degree of consistency of repeatability test results within a test item batch

N：The number of consistent results of a test item = the total number of repeated measurements of a

test item — the number of times the result of the test is inconsistent

3.7 Detection limit

Randomly draw 20 test strips of the same batch number, and configure the first non-negative level of

artificial standard urine of each item (except specific gravity and pH value) according to the method in

Appendix A of the product technical requirements. Each artificial standard urine Repeat the test 20 times

each, and the first non-negative magnitude of each test item should be detectable.

3.8 Analysis specificity

3.8.1 Anti-interference

According to the method in Appendix A of product technical requirements, configure the artificial

standard urine listed in Table 2. Each artificial standard urine test is repeated 3 times, and the test result

should meet the "marked value after interference".

Table 2 Specific detection table

Item Analyte Marked Interferer Interference Marked value

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concentration value concentration after interference

GLU 5.5mmol/l ± Acetoacetate 0.5mmol/l ±

BIL 0 NEG Pyridine 5µl/ml NEG

KET 0 NEG Sunset yellow 20µg/ml NEG

SG —— 1.020 Bovine serum 0.02mg/ml 1.020

albumin

BLD 200cells/µl +++ Sodium chloride 2mg/ml ++～+++

PRO 0 NEG Sodium hydroxide 0.5mg/ml NEG

URO 0.2 ± formaldehyde 10µl/ml ±

NIT 18.12µmol/l + Sodium chloride 10mg/ml +

LEU 500 cells/µl +++ oxalic acid 0.05mg/ml +++

MAL 0 NEG Sodium hydroxide 0.5mg/ml NEG

3.8.2 Anti-vitamin C interference

Randomly draw 10 test strips of the same batch number, and configure each artificial standard urine

added with vitamin C according to the method in Appendix A of product technical requirements. Each

artificial standard urine is tested 10 times, and each item of the test paper is resistant to the interference

of 2.8 mmol/l vitamin C.

3.9 Difference between batches

Randomly draw 3 test papers of different batch numbers, draw 20 strips from each batch, and use

any of the positive artificial standard urine whose concentration is not less than "+" shown in Appendix A

as the test fluid to calculate the test result level of each item between batches The difference between the

test results does not exceed one order of magnitude, and positive results must not appear negative.

4. Analyze performance evaluation data and results

4.1 Working environment conditions

Temperature 20℃～28℃, relative humidity is not more than 80%

4.2 Appearance

Urine analyzer: The outer surface of the analyzer is flat and smooth, uniform in color, free of

scratches, burrs, sharp edges, and deformation. The text of the analyzer should be clear and easy to

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recognize; it should meet the technical requirements of the product.

Test strip:

Lot number: 2019020701 (a) The surface of the urine test strip is flat, and the edges of the polyester film

are free of burrs; (b) The test block and the polyester film are tightly fixed, without defects or falling off; (c)

The test block has a neat appearance, uniform color and no color Spots or stains. Meet the technical

requirements of the product.

Lot number: 2019020901 (a) The surface of the urine test strip is flat, and the edges of the polyester film

are free of burrs; (b) The test block is tightly fixed with the polyester film, without defects or falling off; (c)

The test block has a neat appearance, uniform color and no color Spots or stains. Meet the technical

requirements of the product.

Lot number: 2019021101 (a) The surface of the urine test strip is smooth, and the edges of the polyester

film are free of burrs; (b) The test block is tightly fixed with the polyester film, no defects or shedding; (c)

The test block is neat, uniform in color, and no color Spots or stains. Meet the technical requirements of

the product.

4.3 Loading

Lot number: 2019020701, 100 pieces/box, in line with product technical requirements;

Batch number: 2019020901, 100 pieces/box, in line with product technical requirements;

Batch number: 2019021101, 100 pieces/box, in line with product technical requirements.
4.4 Accuracy
Batch number: 2019020701, the inspection result meets the product technical requirements.
Test items Inspection concentration and result Test items Inspection concentration and result

concentra concent
mark 1 2 3 mark 1 2 3
tion ration

3.3 ± ± ± ± 0 NEG NEG NEG NEG

URO 16 ± ± ± ± GLU 5.5 ± ± ± ±

33 + + + + 14 + + + +

66 ++ ++ ++ ++ 28 ++ ++ ++ ++

133 +++ +++ +++ +++ 55 +++ +++ +++ +++

BIL 0 NEG NEG NEG NEG SG 1.010 1.010 1.010 1.010 1.010

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 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD

17 + + + + 1.020 1.020 1.020 1.020 1.020

50 ++ ++ ++ ++ 1.030 1.030 1.030 1.030 1.030

100 +++ +++ +++ +++

0 NEG NEG NEG NEG 5.0 5.0 5.0 5.0 5.0

0.5 ± ± ± ± 6.0 6.0 6.0 6.0 6.0

KET 1.5 + + + + pH 7.0 7.0 7.0 7.0 7.0

3.9 ++ ++ ++ ++ 8.0 8.0 8.0 8.0 8.0

7.8 +++ +++ +++ +++ 9.0 9.0 9.0 9.0 9.0

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

10 ± ± ± ± 0.6 ± ± ± ±

BLD 25 + + + + VC 1.4 + + + +

80 ++ ++ ++ ++ 2.8 ++ ++ ++ ++

200 +++ +++ +++ +++ 5.6 +++ +++ +++ +++

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

0.15 ± ± ± ± 10 + + + +

URO 0.3 + + + + CRE 20 ++ ++ ++ ++

1.0 ++ ++ ++ ++ 30 +++ +++ +++ +++

3.0 +++ +++ +++ +++

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

NIT 18.1 MALB

+ + + + 0.15 + + + +
2

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

15 ± ± ± ± 0.15 + + + +

LEU 70 + + + + CA 0.3 ++ ++ ++ ++

125 ++ ++ ++ ++ 0.5 +++ +++ +++ +++

500 +++ +++ +++ +++

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Batch number: 2019020901, the inspection result meets the product technical requirements.

Test items Inspection concentration and result Test items Inspection concentration and result

concentra concent
mark 1 2 3 mark 1 2 3
tion ration

3.3 ± ± ± ± 0 NEG NEG NEG NEG

URO 16 ± ± ± ± GLU 5.5 ± ± ± ±

33 + + + + 14 + + + +

66 ++ ++ ++ ++ 28 ++ ++ ++ ++

133 +++ +++ +++ +++ 55 +++ +++ +++ +++

0 NEG NEG NEG NEG 1.010 1.010 1.010 1.010 1.010

17 + + + + 1.020 1.020 1.020 1.020 1.020

BIL SG
50 ++ ++ ++ ++ 1.030 1.030 1.030 1.030 1.030

100 +++ +++ +++ +++

0 NEG NEG NEG NEG 5.0 5.0 5.0 5.0 5.0

0.5 ± ± ± ± 6.0 6.0 6.0 6.0 6.0

KET 1.5 + + + + pH 7.0 7.0 7.0 7.0 7.0

3.9 ++ ++ ++ ++ 8.0 8.0 8.0 8.0 8.0

7.8 +++ +++ +++ +++ 9.0 9.0 9.0 9.0 9.0

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

10 ± ± ± ± 0.6 ± ± ± ±

BLD 25 + + + + VC 1.4 + + + +

80 ++ ++ ++ ++ 2.8 ++ ++ ++ ++

200 +++ +++ +++ +++ 5.6 +++ +++ +++ +++

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

0.15 ± ± ± ± 10 + + + +
URO CRE
0.3 + + + + 20 ++ ++ ++ ++

1.0 ++ ++ ++ ++ 30 +++ +++ +++ +++

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3.0 +++ +++ +++ +++

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

NIT 18.1 MALB

+ + + + 0.15 + + + +
2

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

15 ± ± ± ± 0.15 + + + +

LEU 70 + + + + CA 0.3 ++ ++ ++ ++

125 ++ ++ ++ ++ 0.5 +++ +++ +++ +++

500 +++ +++ +++ +++

Lot number: 2019021101, the inspection result meets the product technical requirements.

Test items Inspection concentration and result Test items Inspection concentration and result

concentra concent
mark 1 2 3 mark 1 2 3
tion ration

3.3 ± ± ± ± 0 NEG NEG NEG NEG

URO 16 ± ± ± ± GLU 5.5 ± ± ± ±

33 + + + + 14 + + + +

66 ++ ++ ++ ++ 28 ++ ++ ++ ++

133 +++ +++ +++ +++ 55 +++ +++ +++ +++

0 NEG NEG NEG NEG 1.010 1.010 1.010 1.010 1.010

17 + + + + 1.020 1.020 1.020 1.020 1.020

BIL SG
50 ++ ++ ++ ++ 1.030 1.030 1.030 1.030 1.030

100 +++ +++ +++ +++

0 NEG NEG NEG NEG 5.0 5.0 5.0 5.0 5.0

0.5 ± ± ± ± 6.0 6.0 6.0 6.0 6.0

KET pH
1.5 + + + + 7.0 7.0 7.0 7.0 7.0

3.9 ++ ++ ++ ++ 8.0 8.0 8.0 8.0 8.0

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7.8 +++ +++ +++ +++ 9.0 9.0 9.0 9.0 9.0

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

10 ± ± ± ± 0.6 ± ± ± ±

BLD 25 + + + + VC 1.4 + + + +

80 ++ ++ ++ ++ 2.8 ++ ++ ++ ++

200 +++ +++ +++ +++ 5.6 +++ +++ +++ +++

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

0.15 ± ± ± ± 10 + + + +

URO 0.3 + + + + CRE 20 ++ ++ ++ ++

1.0 ++ ++ ++ ++ 30 +++ +++ +++ +++

3.0 +++ +++ +++ +++

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

NIT 18.1 MALB

+ + + + 0.15 + + + +
2

0 NEG NEG NEG NEG 0 NEG NEG NEG NEG

15 ± ± ± ± 0.15 + + + +

LEU 70 + + + + CA 0.3 ++ ++ ++ ++

125 ++ ++ ++ ++ 0.5 +++ +++ +++ +++

500 +++ +++ +++ +++

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4.5 Repeatability

Batch number: 2019020701, the test results meet the product technical requirements

Test CRE CA MALB

URO BIL KET BLD URO NIT LEU GLU SG PH VC
items
Mark + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
1 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
2 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
3 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
4 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
5 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
6 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
7 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
8 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
9 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
10 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
11 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
12 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
13 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
14 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
15 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
16 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
17 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
18 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
19 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
20 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
Unifo `100 `100 `100 `100 `100 `100 `100 `100 `100 `100 `100 `100 `100 `100
rm % % % % % % % % % % % % % %

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Batch number: 2019020901, the test results meet the product technical requirements

Test CRE CA MALB

URO BIL KET BLD URO NIT LEU GLU SG PH VC
items
Mark + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
1 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
2 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
3 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
4 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
5 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
6 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
7 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
8 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
9 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
10 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
11 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
12 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
13 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
14 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
15 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
16 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
17 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
18 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
19 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
20 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
Unifo 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
rm

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Batch number: 2019021101, the test result meets the product technical requirements

Test CRE CA MALB

URO BIL KET BLD URO NIT LEU GLU SG PH VC
items
Mark + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
1 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
2 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
3 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
4 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
5 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
6 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
7 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
8 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
9 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
10 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
11 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
12 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
13 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
14 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
15 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
16 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
17 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
18 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
19 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
20 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
Unifo 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
rm

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4.6 Detection limit

Batch number: 2019020701, the test results meet the product technical requirements

Test URO BIL KET BLD URO NIT LEU GLU VC CRE CA MALB

items

Mark ± + ± ± ± + ± ± ± + + +

1 ± + ± ± ± + ± ± ± + + +

2 ± + ± ± ± + ± ± ± + + +

3 ± + ± ± ± + ± ± ± + + +

4 ± + ± ± ± + ± ± ± + + +

5 ± + ± ± ± + ± ± ± + + +

6 ± + ± ± ± + ± ± ± + + +

7 ± + ± ± ± + ± ± ± + + +

8 ± + ± ± ± + ± ± ± + + +

9 ± + ± ± ± + ± ± ± + + +

10 ± + ± ± ± + ± ± ± + + +

11 ± + ± ± ± + ± ± ± + + +

12 ± + ± ± ± + ± ± ± + + +

13 ± + ± ± ± + ± ± ± + + +

14 ± + ± ± ± + ± ± ± + + +

15 ± + ± ± ± + ± ± ± + + +

16 ± + ± ± ± + ± ± ± + + +

17 ± + ± ± ± + ± ± ± + + +

18 ± + ± ± ± + ± ± ± + + +

19 ± + ± ± ± + ± ± ± + + +

20 ± + ± ± ± + ± ± ± + + +

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Batch number: 2019020901, the test results meet the product technical requirements

Test URO BIL KET BLD URO NIT LEU GLU VC CRE CA MALB

items

Mark ± + ± ± ± + ± ± ± + + +

1 ± + ± ± ± + ± ± ± + + +

2 ± + ± ± ± + ± ± ± + + +

3 ± + ± ± ± + ± ± ± + + +

4 ± + ± ± ± + ± ± ± + + +

5 ± + ± ± ± + ± ± ± + + +

6 ± + ± ± ± + ± ± ± + + +

7 ± + ± ± ± + ± ± ± + + +

8 ± + ± ± ± + ± ± ± + + +

9 ± + ± ± ± + ± ± ± + + +

10 ± + ± ± ± + ± ± ± + + +

11 ± + ± ± ± + ± ± ± + + +

12 ± + ± ± ± + ± ± ± + + +

13 ± + ± ± ± + ± ± ± + + +

14 ± + ± ± ± + ± ± ± + + +

15 ± + ± ± ± + ± ± ± + + +

16 ± + ± ± ± + ± ± ± + + +

17 ± + ± ± ± + ± ± ± + + +

18 ± + ± ± ± + ± ± ± + + +

19 ± + ± ± ± + ± ± ± + + +

20 ± + ± ± ± + ± ± ± + + +

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Batch number: 2019021101, the test result meets the product technical requirements

Test URO BIL KET BLD URO NIT LEU GLU VC CRE CA MALB

items

Mark ± + ± ± ± + ± ± ± + + +

1 ± + ± ± ± + ± ± ± + + +

2 ± + ± ± ± + ± ± ± + + +

3 ± + ± ± ± + ± ± ± + + +

4 ± + ± ± ± + ± ± ± + + +

5 ± + ± ± ± + ± ± ± + + +

6 ± + ± ± ± + ± ± ± + + +

7 ± + ± ± ± + ± ± ± + + +

8 ± + ± ± ± + ± ± ± + + +

9 ± + ± ± ± + ± ± ± + + +

10 ± + ± ± ± + ± ± ± + + +

11 ± + ± ± ± + ± ± ± + + +

12 ± + ± ± ± + ± ± ± + + +

13 ± + ± ± ± + ± ± ± + + +

14 ± + ± ± ± + ± ± ± + + +

15 ± + ± ± ± + ± ± ± + + +

16 ± + ± ± ± + ± ± ± + + +

17 ± + ± ± ± + ± ± ± + + +

18 ± + ± ± ± + ± ± ± + + +

19 ± + ± ± ± + ± ± ± + + +

20 ± + ± ± ± + ± ± ± + + +

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4.7 Analysis specificity

4.7.1 Anti-interference analysis

Lot number: 2019020701. The test results meet the technical requirements of the product.

Test
URO BIL KET BLD URO NIT LEU GLU SG MALB
items
Mark + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
1 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
2 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
3 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +

Lot number: 2019020901. The test results meet the technical requirements of the product.

Test
URO BIL KET BLD URO NIT LEU GLU SG MALB
items
MARK + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
1 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
2 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
3 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +

16
 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD
Lot number: 2019021101. The test results meet the technical requirements of the product.

Test
URO BIL KET BLD URO NIT LEU GLU SG MALB
items
mark + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
1 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
2 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +
3 + ++
± NEG NEG NEG + ± 1.020 NEG
+ +

4.7.2 Anti-vitamin C interference

Lot number: 2019020701. The test results meet the technical requirements of the product.

Test items URO BIL KET BLD URO NIT LEU GLU CA SG MALB

mark + + + + + + + + + + +

1 + + + + + + + + + + +

2 + + + + + + + + + + +

3 + + + + + + + + + + +

4 + + + + + + + + + + +

5 + + + + + + + + + + +

6 + + + + + + + + + + +

7 + + + + + + + + + + +

8 + + + + + + + + + + +

9 + + + + + + + + + + +

10 + + + + + + + + + + +

17
 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD
Lot number: 2019020901. The test results meet the technical requirements of the product.

Test items URO BIL KET BLD URO NIT LEU GLU CA SG MALB

mark + + + + + + + + + + +

1 + + + + + + + + + + +

2 + + + + + + + + + + +

3 + + + + + + + + + + +

4 + + + + + + + + + + +

5 + + + + + + + + + + +

6 + + + + + + + + + + +

7 + + + + + + + + + + +

8 + + + + + + + + + + +

9 + + + + + + + + + + +

10 + + + + + + + + + + +

Lot number: 2019021101. The test results meet the technical requirements of the product.

Test
URO BIL KET BLD URO NIT LEU GLU CA SG MALB
items
mark + + + + + + + + + + +

1 + + + + + + + + + + +

2 + + + + + + + + + + +

3 + + + + + + + + + + +

4 + + + + + + + + + + +

5 + + + + + + + + + + +

6 + + + + + + + + + + +

7 + + + + + + + + + + +

8 + + + + + + + + + + +

9 + + + + + + + + + + +

10 + + + + + + + + + + +

18
 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD

4．8 LOT differences

LOT NO.： 2019020701

Test CRE CA MALB

URO BIL KET BLD URO NIT LEU GLU SG PH VC
items
Mark + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
1 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
2 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
3 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
4 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
5 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
6 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
7 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
8 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
9 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
10 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
11 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
12 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
13 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
14 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
15 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
16 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
17 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
18 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
19 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
20 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +

19
 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD
LOT NO.： 2019020901

Test CRE CA MALB

URO BIL KET BLD URO NIT LEU GLU SG PH VC
items
Mark + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
1 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
2 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
3 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
4 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
5 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
6 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
7 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
8 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
9 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
10 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
11 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
12 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
13 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
14 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
15 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
16 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
17 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
18 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
19 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
20 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +

20
 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD
LOT NO.： 2019021101

Test CRE CA MALB

URO BIL KET BLD URO NIT LEU GLU SG PH VC
items
Mark + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
1 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
2 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
3 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
4 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
5 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
6 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
7 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
8 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
9 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
10 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
11 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
12 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
13 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
14 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
15 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
16 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
17 ++ +++ +++ +++ +++ + +++ +++ 1.020 9.0 + ++ + +
18 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
19 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +
20 + +++ +++ +++ +++ + +++ +++ 1.020 8.0 + ++ + +

After batch-to-batch comparison of three batches of products, the test results meet the product technical

requirements.

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 BIOWAY BIOLOGICAL TECHNOLOGY CO.,LTD

5. Analysis performance evaluation summary

Experimental results of urine analysis test strip (dry chemical method) on Yantai Baowei BW-300 urine
analyzer:

Inspection environment: temperature 20℃～28℃, relative humidity not more than 80%

Appearance: (a) The surface of the urine test strip should be flat, with no burrs on the edges of the
polyester film. (b) The test block and the polyester film should be tightly fixed without defects or fallout; (c)
The test block has a neat appearance, uniform color, and no stains or stains. Meet the technical
requirements of the product.

Capacity: 100 pieces/box, in line with product technical requirements.

Accuracy: The difference between the test result and the corresponding reference solution mark is no
more than one order of magnitude in the same direction, and there is no reverse phase difference, which
meets the technical requirements of the product.

Repeatability: The same batch of test papers are repeatedly tested on the same positive specimen,
and the consistency of the test results is not less than 90%, which meets the technical requirements of the
product.

Detection limit: each artificial standard urine test is repeated 20 times. The first non-NEG level of each Test
item should be detectable, which meets the technical requirements of the product.

Analysis specificity: (1) Anti-interference substance: The test result should meet the product index
"post-interference mark", (2) Each test item of the test paper can resist the interference of 2.8 mmol/l
vitamin C. All meet the product technical requirements.

Inter-batch difference: The three batches of test papers are repeatedly tested on the same specimen, and
the difference between the test results does not exceed one order of magnitude, which meets the product
technical requirements.

6．Conclusion

As the above tests show,BW-300 analyzer and the specified reagents have good precision, accuracy

and stable performance, and meet the claimed specifications and practical clinical applications

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