YY/T 1673-2019Amphetamine detection kit ( colloidal gold method ) (English PDF)
安非他明检测试剂盒（胶体金法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 23, 2019
Implementation date
October 1, 2020
Scope
YY/T 1673-2019 is the English-translated version of 安非他明检测试剂盒（胶体金法）.
YY/T 1673-2019 is the Chinese pharmaceutical industry standard for the amphetamine test kit based on colloidal gold immunochromatography, the strip used to screen urine.
It sets the composition of the kit, the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the appearance of the strip, the cut-off concentration and the agreement with reference samples around it, the specificity against related substances, the repeatability and the stability.
It applies to kits for the qualitative detection of amphetamine in human urine. Issued on 23 October 2019, it has applied since 1 October 2020.
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Document preview — YY/T 1673-2019
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Compound Information
- 4 Requirements
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the compound information, requirements, and test methods of amphetamine detection kits (colloidal gold method) (hereinafter referred to as detection kits). Laws, labels and instructions for use, packaging, transportation and storage.
This standard applies to the qualitative detection of amphetamine (AMP) in human urine by the principle of colloidal gold immunochromatography. Detection kit and combined detection kit containing amphetamine. This standard does not apply to.
a) Test kit for non-human urine testing;
b) Test kits using other methods.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191 Packaging, storage and transportation icon
GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostics for professional use Reagent
3 Compound Information
Amphetamine (CAS). 300-62-9, molecular formula. C9H13N, also known as amphetamine. Including its optical isomers and Various types of salt.
4 Requirements
4.1 Physical properties
4.1.1 Appearance
The appearance should be flat, the material should be firmly attached, and the content should be complete. The inner packaging should be clean, free of leaks and not damaged.
4.1.2 Film strip width
The width of the film strip should not be less than 3mm.
4.1.3 Liquid migration speed
The liquid migration speed should not be less than 20mm/min.
4.2 Positive reference rate
Testing with national positive reference materials or standardized positive reference materials should be positive.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1673-2019
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