YY/T 1200-2024 (YY/T1200-2024, YYT 1200-2024, YYT1200-2024) & related versions
YY/T 1200-2024: PDF in English (YYT 1200-2024)
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.
......
| 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. |
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