Study on Clinical Application and Supervision of LC-MS in in Vitro Diagnosis Test / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 690-694, 2023.
Article
in Chinese
| WPRIM
| ID: wpr-1010263
ABSTRACT
From the perspective of technical evaluation, this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years. The regulatory requirements of these products in China, USA, EU and Japan were compared and analyzed, and the monitoring situation of adverse events after listing, the standards for reference and the domestic and foreign regulatory documents were combined, the clinical application and regulatory risks of the product were analyzed. The problems such as pre-treatment, system matching, adequacy of performance index requirements, inter-room consistency, reference interval and registration unit were discussed and suggestions for supervision were given, with a view to the field of product R&D and production, review and approval of supervision to provide technical reference.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Reference Standards
/
Chromatography, Liquid
/
Tandem Mass Spectrometry
/
Japan
Country/Region as subject:
Asia
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2023
Type:
Article
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