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YY/T 1448-2016: Lipoprotein(a) test reagent
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1448-2016 | English | 179 |
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Lipoprotein(a) test reagent
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YY/T 1448-2016
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Basic data | Standard ID | YY/T 1448-2016 (YY/T1448-2016) | | Description (Translated English) | Lipoprotein(a) test reagent | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.110 | | Word Count Estimation | 9,917 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | YY/T 0466.1 | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements, test methods, labeling, labeling and instructions for use of the lipoprotein (a) assay kit, packaging, transport and storage requirements. This standard applies to the use of immunoturbidimetry (transmission method) on human serum or plasma lipoprotein (a) quantitative detection of the kit, including manual reagents and semi-automatic, fully automated biochemical analyzer used in the reagent. | YY/T 1448-2016: Lipoprotein(a) test reagent---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Lipoprotein (a) test reagent
ICS 11.110
C44
People's Republic of China Pharmaceutical Industry Standard
Lipoprotein (a) assay kit
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
The drafting of this standard. Beijing Medical Devices Testing Institute, Beijing nine strong biotechnology Co., Ltd., Beijing Leadman Biochemical shares
Co., Ltd., Zhongsheng North Control Biotechnology Co., Ltd., Sichuan Mike Technology Biology Co., Ltd.
The main drafters of this standard. Bi Chunlei, Huang Yan, Liu Bingzhong, Wang Yunfeng, Dragon Teng, Du Haiou.
Lipoprotein (a) assay kit
1 Scope
This standard specifies the requirements, test methods, labeling, labeling and instructions for use of the lipoprotein (a) assay kit, packaging, transport and storage
And so on.
This standard applies to the use of immunoturbidimetry (transmission method) on human serum or plasma lipoprotein (a) quantitative detection kit, package
Including hand reagents and reagents used in semi-automatic, fully automated biochemical analyzers.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 request
3.1 appearance
Should specify the normal appearance requirements.
3.2 Capacity
Should not be less than the marked value.
3.3 Reagent Blank Absorbance
Should specify the reagent blank absorbance requirements.
3.4 Analysis of sensitivity
When measuring.200 mg/L lipoprotein (a), the absorbance difference (ΔA) should be not less than 0.04.
3.5 Linearity
The linear range of the kit should cover [100,800] mg/L.
a) The linear correlation coefficient (r) should be not less than 0.990;
b) [100,200] mg/L interval, the linear deviation should not exceed ± 20mg/L; (200,800] mg/L interval, the linear deviation
Should not exceed ± 10%.
3.6 precision
3.6.1 Repeatability
Repeated test (300 ± 100) mg/L of human serum or control substance, the results of the coefficient of variation CV (%) should not be greater than 4%.
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