YY/T 1200-2024_English: PDF (YY/T1200-2024)
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Glucose assay kit (Enzymic method)
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| Standard ID | YY/T 1200-2024 (YY/T1200-2024) | | Description (Translated English) | Glucose assay kit (Enzymic method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 9,966 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2025-03-01 | | Older Standard (superseded by this standard) | YY/T 1200-2013 | | Administrative Organization | National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC 136) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, labels and instructions for use, packaging, transportation and storage of glucose determination kits (enzymatic method), and describes the corresponding test methods. This document is applicable to the hexokinase method and glucose oxidase method determination kit, which is used for quantitative analysis of glucose concentration in serum, plasma, urine, cerebrospinal fluid and other body fluids in clinical testing. | | Standard ID | YY/T 1200-2013 (YY/T1200-2013) | | Description (Translated English) | Glucose assay kit (Enzymic method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,920 | | Quoted Standard | GB/T 191 | | Drafting Organization | Chinese Academy of Food and Drug Testing | | Administrative Organization | National Medical clinical testing laboratories and in vitro diagnostic systems for Standardization Technical Committee | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the principles for measuring glucose assay kit (enzymatic), requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to hexokinase and glucose oxidase assa |
YY/T 1200-2024.Glucose Determination Kit (Enzymatic Method)
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1200-2013
Glucose Assay Kit (Enzymatic Method)
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 1200-2013 "Glucose Determination Kit (Enzymatic Method)". Compared with YY/T 1200-2013, except for the structural adjustment
In addition to the integration and editorial changes, the main technical changes are as follows.
--- Changed the requirements for reagent blank absorbance (see 4.3, 4.3 of the.2013 edition);
--- Changed the linearity requirements (see 4.4, 4.4 of the.2013 edition);
--- Changed the accuracy requirements and test methods (see 4.5, 4.5 of the.2013 edition);
--- Changed the applicable range of analytical sensitivity (see 4.6, 4.6 of the.2013 edition);
--- Changed the repeatability requirements (see 4.7.1, 4.7.1 of the.2013 edition);
--- Changed the requirements for batch differences (see 4.7.2, 4.7.2 of the.2013 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. China Food and Drug Inspection Institute, Beijing Jiuqiang Biotechnology Co., Ltd., and Mike Biotech Co., Ltd.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Beijing Leadman Biochemical Co., Ltd., Abbott Trading (Shanghai) Co., Ltd.,
Siemens Medical Diagnostics (Shanghai) Co., Ltd., Sinopharm Biopharmaceuticals Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd.
company.
The main drafters of this document are. Sun Nan, Qu Shoufang, Yu Ting, Chen Yang, Chen Qiyun, Wan Xianzi, Ren Ruixia, Wu Xiaojun, Zhang Tingting, Qu Anjiang,
Wang Rongfei.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2013 as YY/T 1200-2013;
---This is the first revision.
Glucose Assay Kit (Enzymatic Method)
1 Scope
This document specifies the requirements, labeling and instructions for use, packaging, transportation and storage of glucose determination kits (enzymatic method) and describes the corresponding
test method.
This document is applicable to the hexokinase method and glucose oxidase method assay kits, which are used for quantitative analysis of blood in clinical testing.
Glucose concentration in body fluids such as serum, plasma, urine, and cerebrospinal fluid.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products, and should include requirements for the composition and properties of the components of the test kit.
4.2 Net content
The net content of liquid reagents should not be less than the labeled amount.
4.3 Reagent Blank Absorbance
The absorbance of the reagent blank should not be greater than 0.6 (wavelength given by the manufacturer, light path 1.0 cm).
Note. Not applicable to dry analyzer test reagents.
4.4 Linearity
The linearity should meet the following requirements.
a) The linear range of glucose concentration should cover. [0.6, 25.0] mmol/L;
b) The linear correlation coefficient (r) should be no less than 0.9900;
c) In the range of [0.6~5.0]mmol/L, the absolute linear deviation should be within the range of ±0.50mmol/L; (5.0~25.0]mmol/L
Within the range, the linear relative deviation should be within ±10.0%.
4.5 Accuracy
Use one of the following methods for verification in the following order of priority.
......
YY/T 1200-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Glucose assay kit (Enzymic method)
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Determination Principle ... 4
4 Requirements ... 5
5 Test Method ... 6
6 Mark, Label and Instructions ... 9
7 Packaging, Transport and Storage ... 11
Foreword
This Standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
Please note that some contents in this Document may involve patents. The issuing
organization of this Document does not undertake the responsibility to identify these
patents.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of the China Clinical Laboratory Testing and
In vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
Drafting organization of this Standard. National Institute for Food and Drug Control.
The main drafters of this Standard. Wang Yumei, Liu Yan, and Gao Shangxian.
Glucose assay kit (Enzymic method)
1 Scope
This Standard specifies the determination principle, requirements, test method, mark, label,
instructions, packaging, transport and storage, etc. of glucose assay kit (enzymic method).
This Standard uses glucose hexokinase and oxidase method to measure the kit which is
used for the quantitative analysis of glucose concentration for serum, plasma, urine,
cerebrospinal fluid and other body fluids in clinical examination.
2 Normative References
The articles contained in the following document have become part of this Document when
they are quoted herein. For the dated documents so quoted, all the modifications (including
all corrections) or revisions made thereafter shall be applicable to this document.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
3 Determination Principle
3.1 Hexokinase method
Glucose + ATP ----------→ glucose-6-phosphoric acid + ADP
Glucose-6-phosphoric acid + NAD+ ------→ 6-phosphate acid glucose aldehyde acid +
NADPH + H+
Assay method. end-point method
Detection wavelength. the wavelength given by the manufacturer.
3.2 Glucose oxidase method
Glucose + O2 + H2O -----→ gluconic acid + H2O2
2H2O2 + 4-amino antipyrine + phenol ------→ quinone-imine + 4H2O
Assay method. end-point method
hexokinase
G6PDH
GOD
POD
Where.
R - recovery rate;
V - volume of standard solution added;
Vo - volume of human serum sample;
C - measured concentration of human serum sample after adding standard solution;
co - measured concentration of human serum sample;
cs - concentration of standard solution.
5.6 Analysis sensitivity
Dilute the sample with certain concentration (n units of material to be tested). Measure the
absorbance. Calculate the concentration of sample whose light absorption value and blank
absorption value are different. The results shall meet the requirements of 4.6.
5.7 Precision
5.7.1 Within-batch precision
Test the reagent (kit) with high and low-value quality control materials (divided into normal
interval and pathological interval). Repeat the test for 10 times. Calculate the mean value
(̅ݔ) and standard deviation (SD) of measured values respectively. Calculate the coefficient
of variation (CV) of within-batch precision according to Formula (4).
Use high and low-value quality control materials to respectively determine the same-batch
of 20 kits to be tested. Calculate the mean value (̅ݔ1) and standard deviation (SD1) of the
20 measured results.
Use the same quality control material to repeatedly determine the same-batch of 1 kit to
be tested for 20 times. Calculate the mean value (̅ݔ2) and standard deviation (SD2) of the
measured results. Calculate the coefficient of variation (CV) of the deviation between the
bottles (lyophilized powder) according to Formula (5) and (6).
When SD1< SD2, take CV=0.
The results shall meet the requirements of 4.7.1.
SDbetween-bottles
c) Net content of product;
d) Production batch number;
e) Expiry date;
f) Storage conditions.
6.3 Instructions
The instructions shall include the following contents.
a) Product name;
b) Packaging specification;
c) Intended use;
d) Test principle;
e) Main components;
f) Storage conditions and expiry date;
g) Applicable instruments;
h) Sample requirements;
i) Test method;
j) Reference value (reference interval);
k) Explanation of test results;
l) Limitation of the test method;
m) Product performance index;
n) Precautions;
o) References;
p) Manufacturing enterprise;
q) Production enterprise license number of medical device;
r) Registration certificate number of medical device;
s) Product standard number;
t) Approval and modification date of the instructions.
7 Packaging, Transport and Storage
7.1 Packaging
7.1.1 Packaging for storage and transport
The packaging for storage and transport AND marking of the kit shall meet the
requirements of GB/T 191.
7 1.2 Unit packaging
7.1.2.1 The kit shall be complete, labeled clearly, sealed tightly, and free of leakage.
7.1.2.2 The instructions shall be enclosed within the kit.
7.2 Transport
Product transport shall be carried out according to the provisions of contract.
7.3 Storage
Kit shall be stored under the conditions specified by the manufacturer.
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