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Ischemia-modified albumin test reagent
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Basic data
| Standard ID | YY/T 1461-2016 (YY/T1461-2016) |
| Description (Translated English) | Ischemia-modified albumin test reagent |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 8,828 |
| 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 terms, requirements, test methods, labels, instructions for use, packaging, transport and storage of ischemic modified albumin assay reagents (albumin-cobalt binding). This standard is applicable to reagents (cartridges) for quantitative detection of ischemic modified albumin (IMA) in human serum using albumin-cobalt binding methods, based on spectrophotometric principles, including manual reagents and in semi-automatic, fully automated biochemical analyzers On the use of reagents. |
YY/T 1461-2016: Ischemia-modified albumin test reagent
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Ischemia-modified albumin test reagent
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Ischemic modified albumin determination reagent (box)
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 Device Testing Institute, Ningbo Meikang Biotechnology Co., Ltd., Beijing nine strong biotechnology stocks
Co., Ltd., Sichuan Province into a new biotechnology limited liability company.
The main drafters of this standard. Yang Zongbing, Zou Bingde, Huang Yan, Chen Wei.
Ischemic modified albumin determination reagent (box)
1 Scope
This standard specifies the terms, requirements, test methods, labels for the use of ischemic modified albumin determination reagents (cassettes) (albumin-cobalt binding)
With instructions, packaging, transportation and storage.
This standard is applicable to reagents (cartridges) for quantitative detection of ischemic modified albumin (IMA) in human serum using albumin-cobalt binding methods,
Based on spectrophotometric principles, 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 terminology
The following terms and definitions apply to this document.
3.1
1U/mL "ischemic modified albumin" 1U/mLischemia-modifiedalbumin
1 mL of healthy human serum albumin (45 g/L) was defined as 1 U/mL & quot; ischemic modified albumin & quot; when bound to 1 [mu] g of Co2,
When expressed as albumin cobalt ion binding capacity, it is converted to the value of "ischemic modified albumin" by the formula specified by the manufacturer.
4 requirements
4.1 appearance
Should specify the normal appearance requirements.
4.2 Capacity
The net content of the liquid reagent shall be not less than the indicated value.
4.3 Reagent Blank absorbance
Reagent blank absorbance should be not less than 0.6.
4.4 Analyze sensitivity
The absorbance difference (ΔA) should be less than 0.15 when the test result is 78.0U/mL.
4.5 linearity
The linear range of reagent (box) should be covered [40.0,120.0] U/mL.
a) linear correlation coefficient ︱ r︱ should not be less than 0.995;
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