Search result: YY/T 1585-2024 (YY/T 1585-2017 Older version)
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25-Hydroxyl vitamin D testing kit
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YY/T 1585-2024
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| YY/T 1585-2017 | English | 199 |
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Total 25-hydroxyl vitamin D testing kit(labelling immunoassay)
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YY/T 1585-2017
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| Standard ID | YY/T 1585-2024 (YY/T1585-2024) | | Description (Translated English) | 25-Hydroxyl vitamin D testing kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 14,177 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2025-10-15 | | Older Standard (superseded by this standard) | YY/T 1585-2017 | | Drafting Organization | Beijing Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), National Health Commission Clinical Inspection Center, Zhejiang Medical Device Review Center, Zhengzhou Antu Bioengineering Co., Ltd., Beijing Shuimu Jiheng Biotechnology Co., Ltd., Beijing Hospital, Kemei Diagnostic Technology Co., Ltd., Abbott Trading (Shanghai) Co., Ltd. | | Administrative Organization | National Technical Committee for Standardization of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC 136) | | Proposing organization | National Drug Administration | | Issuing agency(ies) | National Drug Administration | | Summary | This standard specifies the requirements, identification, labeling, instructions for use, packaging, transportation and storage of 25-hydroxyvitamin D assay kits, and specifies the corresponding test methods. This standard is applicable to kits for quantitative detection of total 25-hydroxyvitamin D, 25-hydroxyvitamin D2, and 25-hydroxyvitamin D3 in human serum or plasma, including labeled immunoassay (such as enzyme labeling, luminescent labeling, etc.), immunochromatography, immunoturbidimetry, and liquid chromatography-tandem mass spectrometry. |
YY/T 1585-2024. 25-Hydroxyvitamin D Assay Kit
Pharmaceutical Industry Standards of the People's Republic of China
ICS 11.100.10CCS C 44
25-Hydroxyvitamin D Assay Kit
25⁃Hydroxyl vitamin D testing kit
2024-09-29 Release
2025-10-15 Implementation
The State Drug Administration issued
Replaces YY/T 1585-2017
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 is required.
This document replaces YY/T 1585-2017 "Total 25-hydroxyvitamin D Assay Kit (Labeled Immunoassay)" and is compatible with YY/T 1585-
Compared with.2017, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
-- The scope adds the methodologies applicable to this document and deletes the inapplicable contents of this document (see Chapter 1,.2017 edition).
Chapter 1);
-- The classification method has been deleted (see Chapter 4 of the.2017 edition);
--The main changes in technical indicators are as follows.
l Changed the appearance requirements (see 4.1.1 and 4.2.1, 4.1 of the.2017 edition),
l Changed the linearity requirements (see 4.1.3 and 4.2.3, 4.5 of the.2017 edition),
l Changed the repeatability requirements (see 4.1.4 and 4.2.4, 4.6 of the.2017 edition),
l Changed the accuracy requirements (see 4.1.6 and 4.2.6, 4.3 of the.2017 edition),
l Changed the detection limit requirements (see 4.1.7 and 4.2.7, 4.4 of the.2017 edition),
l Added the limit of quantification requirements (see 4.1.8 and 4.2.8),
l Added analytical specificity requirements (see 4.1.9 and 4.2.9);
--The test method has been changed to be compatible with the requirements of Chapter 4 (see Chapter 5, Chapter 5 of the.2017 edition);
--Changes have been made to packaging, transportation and storage (see Chapter 7, Chapter 7 of the.2017 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/TC 136).
This document was drafted by. Beijing Institute of Medical Device Inspection (Beijing Medical Bioprotection Equipment Inspection and Research Center), National Health Commission of China
National Health Commission Clinical Laboratory Center, Zhejiang Medical Device Evaluation Center, Zhengzhou Antu Bioengineering Co., Ltd., Beijing Shuimu Jihengsheng
Biotechnology Co., Ltd., Beijing Hospital, Comed Diagnostics Technology Co., Ltd., and Abbott Trading (Shanghai) Co., Ltd.
The main drafters of this document are. Sun Xueqing, Zhou Weiyan, Ye Chaofu, Zhang Lihong, Yang Zongbing, Qiang Zhonghua, Wu Xiaojun, Wu Kechun, and Zhang Chuanbao.
The previous versions of this document and the documents it replaces are as follows.
--First published in.2017 as YY/T 1585-2017;
--This is the first revision.
25-Hydroxyvitamin D Assay Kit
1 Scope
This document specifies the requirements, identification, labeling and instructions for use, packaging, transportation and storage of 25-hydroxyvitamin D assay kits.
The corresponding test methods are described.
This document is applicable to the quantitative detection of total 25-hydroxyvitamin D, 25-hydroxyvitamin D2, 25-hydroxyvitamin
D3 kits include labeled immunoassays (such as enzyme labeling, luminescent labeling, etc.), immunochromatography, immunoturbidimetry, and liquid chromatography-tandem
Mass spectrometry, etc.
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 191 Pictorial markings for packaging, storage and transportation
GB/T 21415 Metrological traceability of values assigned to calibrators and control materials for the measurement of quantities in biological samples of in vitro diagnostic medical devices
Origin
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 Liquid chromatography-tandem mass spectrometry kit
4.1.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, the components and properties of the kit should be
Requirements for outer packaging, labeling, etc.
4.1.2 Traceability
If calibrators are included, the manufacturer shall provide the source, value assignment process and
Measurement uncertainty etc.
4.1.3 Linearity
The linear range of 25-hydroxyvitamin D2 should cover [4.0, 100.0] ng/mL. Within the linear range specified by the manufacturer, the correlation coefficient
(r) should not be less than 0.990 0.In the interval [4.0, 15.0] ng/mL, the absolute deviation should not exceed ±2.25 ng/mL, (15.0, 100.0] ng/mL
Within the range, the relative deviation should not exceed ±15.0%.
......
YY/T 1585-2017
Total 25-hydroxyl vitamin D testing kit (labelling immunoassay)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Total 25-hydroxy vitamin D assay kit
(Labeled immunoassay)
Total25-hydroxylvitaminDtestingkit (labelingimmunoassay)
2017-12-05 Published
2018-12-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Inspection Institute, Siemens Medical Diagnostic Products (Shanghai) Co., Ltd., Abbott Trading (Shanghai) Co.,
Limited, Beijing Kemei Biotechnology Co., Ltd.
The main drafters of this standard. Zou Ying Shu, Wang Shaoying, Wang Xuefeng, strong Chinese.
Total 25-hydroxy vitamin D assay kit
(Labeled immunoassay)
1 Scope
This standard specifies the total 25-hydroxy vitamin D assay kit (labeled immunoassay) classification, requirements, test methods, identification,
Labels and instructions for use, packaging, transportation and storage.
This standard applies to quantitative determination of total 25-hydroxy vitamin D kit. Including enzyme labeling, (electricity) chemiluminescence labeling and other standards
In order to capture the antibody, microplate, tube, magnetic particles, beads and plastic beads as carrier antibody for coating, for in vitro quantitative detection of human serum
Or plasma total 25-hydroxy vitamin D immunoassay kit.
This standard does not apply to.
a) qualitative or semi-quantitative determination of human total 25-hydroxyvitamin D labeled with colloidal gold or other methods (eg, test strip, raw
Chip, etc.);
b) Total 25-hydroxyvitamin D and 25-hydroxyvitamin D controls to be sold separately.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB/T 21415 In Vitro Diagnostic Medical Devices Measurement of Biological Samples The calibration and control material assignments are metered
Source
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS
3 categories
Total 25-hydroxy vitamin D according to the labeling method can be divided into enzyme-labeled total 25-hydroxy vitamin D kit, (electrification)
Total 25-hydroxyvitamin D kit, (time-resolved) fluorescently labeled total 25-hydroxy vitamin D kit and the like; according to the solid phase
The carrier can be divided into different microplates, tubes, magnetic particles, beads and plastic beads as the carrier of the total 25-hydroxy vitamin D kit; roots
According to the operation process can be divided into manual methods and automatic operation of the instrument total 25-hydroxy vitamin D kit.
4 requirements
4.1 appearance
Kit components should be complete, complete, liquid leakage.
4.2 Traceability
Manufacturers should be based on GB/T 21415 and the relevant provisions of the sources used to provide the calibration process, as well as uncertainty and so on.
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