YY/T 1233-2014 (YY/T1233-2014, YYT 1233-2014, YYT1233-2014) & related versions
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Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
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YY/T 1233-2014
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YYT 1233-2014
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YY/T 1233-2014: PDF in English (YYT 1233-2014)
YY/T 1233-2014
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the People’s Republic of China
Cardiac troponin-I (cTnI)
quantitative detection reagent (kit)
(Chemiluminescent immunoassay)
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 1, 2015
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marks, labels and instructions ... 9
7 Packaging, transportation and storage ... 11
Foreword
This Standard was drafted according to the rules given by GB/T 1.1-2009.
Please note that some contents of this Document may involve patents. The issuing
authority of this Document does not undertake the responsibility for the identification
of these patents.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of the Standardization Technical
Committee of National Medical Clinical Test Laboratory and in Vitro Diagnostic
System (SAC/TC 136).
Main drafting organizations of this Standard. Beijing Institute of Medical Device
Testing, Zhengzhou Auto Biological Engineering Co., Ltd., Beckman Coulter Trading
(China) Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd., Abbott Trading
(Shanghai) Co., Ltd., and Johnson & Johnson (Shanghai) Medical Equipment Co.,
Ltd.
Main drafters of this Standard. Wang Ruixia, Li Xiaoxia, Zhang Jinwen, Du Haiou, Liu
Rong, Wang Xuefeng, and Qi Xin.
Cardiac troponin-I (cTnI)
quantitative detection reagent (kit)
(Chemiluminescent immunoassay)
1 Scope
This Standard specifies the terms and definitions, requirements, test methods,
marking, labeling, instructions, packaging, transportation, and storage of cardiac
troponin-I (cTnI) quantitative detection reagent (kit) (chemiluminescent
immunoassay).
This Standard applies to the quantitative detection of human cardiac troponin-I (cTnI)
quantitative detection reagent (kit) [hereinafter referred to as "cTnI reagent (kit)"] by
the principal of chemiluminescent immunoassay, including the enzymatic and
non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers
such as microplates, tubes, and magnetic particles.
This Standard does not apply to the requirements for the calibrator and control
materials in reagent (kit).
2 Normative references
The following document is essential for the application of this Document. For dated
references, only dated versions apply to this Document. For undated references, the
latest version (excluding corrections) applies to this Document.
GB/T 21415 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrator and
control materials
3 Terms and definitions
The following terms and definitions apply to this Document.
3.1
limit of blank; LOB
In claimed probability, the highest measurement result of blank sample that can be
observed.
[NCCLS, EP17]
4 Requirements
4.1 Appearance
Appearance shall meet the following requirements.
a) Each component of reagent (kit) shall be complete, intact, and no leakage of
liquid;
b) Chinese packaging labels shall be clear, without wear and tear.
4.2 Traceability
Manufacturing enterprise shall provide the contents such as source, traceable
assignment process, corresponding requirements, and uncertainty of the cTnI
calibrator used, according to GB/T 21415 and the relevant provisions.
4.3 Accuracy
Accuracy shall meet one of the following requirements.
a) USE reference material as the sample to perform detection. The relative
deviation of measurement results shall be within the interval of ± 20%.
b) ADD the cardiac troponin-I (cTnI) of known concentration INTO the blood matrix
or other body fluid components. The recovery rate shall be within the interval
(85%~115%).
4.4 Blank limit
It shall meet the requirements of the manufacturer, and not higher than the upper limit
of the reference interval of normal people.
4.5 Linear interval
The upper limit of linear interval shall not be lower than 25ng/mL; the lower limit shall
be lower than the reference interval of normal people. Within the linear interval
specified by manufacturing enterprise, the correlation coefficient of reagent kit |r| shall
be ≥0.990.
4.6 Repeatability
USE the sample of which the critical value of acute myocardial infarction is at ± 50%
level, to test repeatedly for 10 times. Its coefficient of variation (CV) shall not exceed
10% (instrument automatic operation method) or not more than 15% (manual
operation method).
r) Manufacturing enterprise;
s) License number of medical device manufacturing enterprise;
t) Medical device registration certificate number;
u) Product standard number;
v) Instructions’ approval and modification date.
7 Packaging, transportation and storage
7.1 Packaging
It shall be intact, no leak, and no damage.
7.2 Transportation
Reagent (kit) shall be transported according to the requirements of manufacturing
enterprise.
7.3 Storage
Reagent (kit) shall be stored under the conditions specified by manufacturing
enterprise.
......
| Standard ID | YY/T 1233-2014 (YY/T1233-2014) | | Description (Translated English) | Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,825 | | Date of Issue | 2014/6/17 | | Date of Implementation | 2015/7/1 | | Quoted Standard | GB/T 21415 | | Drafting Organization | Beijing Medical Device Testing | | Administrative Organization | National medical clinical testing laboratory and in vitro diagnostic systems Standardization Technical Committee | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to human cardiac troponin -I (cTnI) reagent (box) quantitative determination principle to CLIA law, including microplates, tubes, magnetic particles as carrier enzymatic and non-enzymatic chemiluminescence immunoassay assay reagent ( |
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