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YY/T 1207-2013: Uric acid assay kit (Uricase-PAP method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1207-2013 | English | 189 |
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Uric acid assay kit (Uricase-PAP method)
| Valid |
YY/T 1207-2013
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Basic data | Standard ID | YY/T 1207-2013 (YY/T1207-2013) | | Description (Translated English) | Uric acid assay kit (Uricase-PAP method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 8,827 | | Quoted Standard | YY/T 0466.1 | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: uric acid assay kit (peroxidase-conjugated uricase method) requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: uric acid assay kit (peroxidase-co | YY/T 1207-2013: Uric acid assay kit (Uricase-PAP method)---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.
Uric acid assay kit (Uricase-PAP method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Uric acid assay kit
(Uricase peroxidase conjugated method)
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this standard may involve patents. The standard release mechanism does not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard drafting unit. China Academy of Food and Drug test.
The main drafters of this standard. Liu Yan, Sun Nan, Wang Yumei, Zhangchun Tao, noble first.
Uric acid assay kit
(Uricase peroxidase conjugated method)
1 Scope
This standard specifies the uric acid assay kit (uricase peroxidase conjugated Act) requirements, test methods, marking, labeling and use of said
Specification, packaging, transportation and storage.
This standard applies to uric acid assay kit (uricase peroxidase conjugated method) quality control.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Requirements
3.1 Appearance
Compatible with the manufacturer's appearance requirements.
3.2 PACKING
Liquid reagent loading amount not less than the labeled amount.
3.3 reagent blank absorbance
At 500nm ~ 550nm wavelength, dual reagent blank absorbance of uric acid assay kit should be less than 0.200, a single measurement of uric acid reagent
Blank absorbance given the kit should be less than 0.300.
3.4 Linear Interval
Within the linear range specified by the manufacturer, and the theoretical concentration measured concentrations of the linear correlation coefficient (r) shall not be less than 0.9900.
3.5 Accuracy
Use standard product has traceability was measured relative deviation of the measured value and the value declared shall be within ± 10.0%.
3.6 Sensitivity Analysis
When test kits given concentration of analyte, change in absorbance (ΔA) shall comply with the manufacturer's given range.
3.7 Precision
3.7.1 within run precision
Intra-assay precision should be less than 4.0%.
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