Foreword
This standard was formulated according to "’Supervision and Administration Regulations of Medical Device", "Administration Methods of Medical Device Standards" and "Registration Administration Methods of in vitro Diagnostic Reagents (Trial)", and is used as the quality basis of production, inspection and marketing of this product.
The content of the standard was compiled according to "China Regulations of biological" (2000 edition) and 2002 supplement.
The format of the standard follows "Compiling Norms of Medical Device Registration Product Standards" and GB/T 1.1-2009 "Standardization Work Guidance Principle Part 1: Standard Structure and Compiling Rules".
The standard was proposed by Hexi Medical Science and Technology Trading (Shanghai) Co., Ltd.
The drafting unit of the standard: Hexi Medical Science and Technology Trading (Shanghai) Co., Ltd.
The main drafter of the standard: Yang Yu.  
This standard was first released on May 15, 2013.

Creatine kinase isoenzyme assay kit (DGKC/IFCC method)
1 Scope 
This standard specifies the product categories, specifications, requirements, test methods, marks, labels and instructions, package, transportation, storage, etc. of the creatine kinase isoenzyme assay kit (DGKC/IFCC method) (hereinafter referred to as "kit").
This standard applies to the creatine kinase isoenzyme assay kit (DGKC/IFCC method). This kit is an in vitro diagnostic reagent.
2 Normative cited documents 
The provisions in the following documents have become the provisions of this standard through citation by the standard. For dated documents which were cited, all of their subsequent amendment forms (excluding the content of corrigendum) or revisions do not apply to this standard, however, it is encouraged that all parties who have reached an agreement on this standard discuss if the latest versions of these documents can be used. For undated documents which were cited, their latest versions apply to this standard.
GB191/T-2008 Graphic marks of package, storage and transportation
YY0466-2003 Medical device: symbols which are used for medical device labels, marks, and providing information
3 Classified composition and specifications 
3.1 Classification
According to the provisions related to product classification in "Registration Administration Method of in vitro Diagnostic Reagents (Trial)", this kit is administrated as a class Ⅱ in vitro diagnostic reagent product.
3.2 Composition

R1	R2
Imidazole	Imidazole
Glucose	ADP
N-acetylcysteine (NAC)	AMP
Magnesium acetate	Glucose-6-phosphate dehydrogenase(G6P-DH)
EDTA-Na2	Di(adenosine-5') penta- phosphate
NADP	Creatine kinase
Hexokinase(HK)	Stabilizer
Human CK-M monoclonal antibody; suppression ability

 
3.3 specifications

Specification 1	R1	4x25ml
	R2	1x25ml
Set	R1	4x62.5ml
	R2	1x62.5ml

4 Requirements 
4.1 Appearance
The kit should be packaged in intact condition with no damage, and its words and marks should be clear.
The reagent is liquid, and there should be no particles, precipitation and floc.
4.2 Net content
The net content of the reagent should not be less than the labeled value.
4.3 Reagent blank
4.3.1 The reagent blank absorbance
The reagent blank absorbance should be ≤ 1.0.
4.3.2 The change rate of the reagent blank absorbance
The change rate of the reagent blank absorbance should be ≤ 0.001.
4.4 Analysis sensitivity
When a 100U/ L sample is tested, the change rate of the absorbance (ΔA/min) should not be less than 0.005.
4.5 Accuracy
Comparison tests are performed
a) The relative coefficient of two groups of results r ≥ 0.99
b) Among the range of (2 ~ 100) U/L, absolute deviation does not exceed ± 15U/ L;
c) Among the range of (100 ~ 2000) U/L, the relative deviation ≤ ± 15%.
4.6 Intra-batch precision
CV ≤ 5%.  
4.7 Linear range
Among the detection range of (2 ~ 2000) U/L
a) linear correlation coefficient r ≥ 0.99
b) Among the range of (2 ~ 100) U/L, absolute deviation does not exceed ± 15U/ L;
c) Among the range of (100 ~ 2000) U/L, the relative deviation ≤ ± 15%.
4.8 Stability
If the kit is stored under the specified conditions, at the end of the period of validity, it should meet the provisions of 4.3, 4.4, 4.5, 4.6 and 4.7.
4.9 Inter-batch precision
Relative maximum difference of the kits with different batch numbers ≤ 5%.
5 Test Methods 
5.1 Appearance
Visual results should meet the requirements of 4.1.
5.2 Net content
A graduated cylinder is used for measurement, and the content should meet the requirement of 4.2.
5.3 Reagent blank
Distilled water is used to test a kit at the main wavelength. The absorbance value (A1) at the start of the test and the absorbance value (A2) about 5min (t) later are recorded. Above measurement is repeated twice. A2 should meet the requirement of 4.3.1; the change rate of the absorbance value is calculated (│A1-A2│/t), and should meet the requirement of 4.3.2.
5.4 Analysis sensitivity
Samples with known activity are used to test. The change rate of absorbance value is recorded, and then is converted to the change rate of absorbance value (ΔA/ min) responding to 100U/ L and it should meet the requirement of 4.4.
5.5 Accuracy
Not less than 40 human samples with different concentrations among the detection range are used. Each sample is tested according to the operation method of the kit to be tested and the comparison method. Then, the correlation coefficient of two groups of results is calculated and the deviation of each concentration point is also calculated. These calculated values should meet the requirements of 4.5.
5.6 Intra-batch precision
Each of high, low quality control materials is used to test 20 times. The mean and the SD of the results are calculated, and then the CV values are calculated and it should meet the requirement of 4.6.

5.7 Linear range  
The sample with concentration close to the upper limit of the linear range is diluted to at least 5 gradient concentrations according to a certain proportion. Above concentrations should cover the whole linear range as far as possible, and each concentration is detected three times, respectively. The mean of the test results is calculated, and the linear correlation coefficient r of the dilution proportion is also calculated. Then, the relative deviation between the mean of the test results and the estimated value is calculated. All calculated results should meet the requirements of 4.7.

5.8 Stability
The kit is stored under specified conditions, and at the end of the period of validity, tests are performed according to the test methods specified by 5.3, 5.4, 5.5, 5.6 and 5.7. The results should meet the requirements of 4.8.
5.9 Inter-batch precision
Each of three kits with different batch numbers is used to test the same high and low quality control samples three times, respectively, and three means are calculated and then total mean is calculated. Among the three means, the difference between the maximum mean and the minimum mean is calculated, and the difference is divided by the total mean. The calculated result becomes percentage, and it should meet the requirement of 4.9.

6 Marks, labels and instructions 
China Food and Drug Administration Decree 10 "Administration Regulations of Medical Device Instructions, Labels and Package Marks" and the relevant provisions of YY0466-2003 should be complied with.
6.1 Reagent external marks should include at least the following content:
a) Product name, package specification;
b) Manufacturer's name, address;
c) Batch number and period of validity;
d) Storage condition.
6.2 Reagent composition form package should include at least the following content:
a) Product name;
b) Package specification;
c) Product batch or production date;
d) Period of validity;
e) Storage condition.
6.3 The product instructions should include at least the following content:
a) Product name and package specification;
b) Test principle and test method;
c) Reagent composition and performance characteristics;
d) Notes and references;
e) Storage condition and expiry date;
f) Manufacturer's name, address and contact information;
g) The approval or revision date of the instructions.
7 Package, transportation and storage 
Overview: graphic marks of package, storage and transportation should meet the requirements of GB191/T-2008
7.1 Package
The package of the kit should be intact.
7.2 Transportation
The kit should be transported according to the specified conditions.
7.3 Storage
If the kit is stored under the conditions of 2℃-8℃, it is stable until the labeled expiry date.

Description of compiling
 
1 The source and background of the task 
The kit applies to in vitro diagnosis and is used to determine content of creatine kinase isoenzyme in serum or plasma by an analyzer.
Currently there is no national standard or industry standard of this kind of products. According to Chinese "Standardization Law", in accordance with the relevant regulations of the relevant medical device registration product standard compiling norms of China Food and Drug Administration, the registration product standard is specially formulated. The compilation of this standard has complied with the rules determined by GB/T 1.1-2009 "Standardization Work Guidance Principle" standard.
2 The description of main performances and requirements of this standard
In the product quality control of the kit, specific technical indicators, such as appearance, net content, sensitivity, accuracy, intra-batch precision, linear range, inter-batch precision, stability, are formulated by referring to the instructions and the relevant technical materials of Hexi Medical Science and Technology Trading (Shanghai) Co., Ltd. Appearance is mainly the requirement to the kit package; net content, sensitivity, accuracy, intra-batch precision and linearity range are all used to verify the performance indicators of the reagent; inter-batch precision examines the degree of consistency between different batches of reagents to ensure that the test results of kits with different batch numbers are comparable; stability examines the performance of the kit under the specified storage conditions at the end of the period of validity.
3 The cited standards and reference materials
GB191/T-2008 Graphic marks of package, storage and transportation
GB/T 1.1-2009 "Standardization Work Guidance Principle Part 1: Standard Structure and Compiling Rules"
YY0466-2003 Medical device: symbols which are used for medical device labels, marks, and providing information
China Food and Drug Administration Decree 10 "Administration Regulations of Medical Device Instructions, Labels and Package Marks"
Hexi Medical Science and Technology Trading (Shanghai) Co., Ltd "creatine kinase isoenzyme assay kit (DGKC/IFCC method) instructions" 

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