Brief Discussion on Representative Models of Instruments for In Vitro Diagnostic Reagents.
10.12455/j.issn.1671-7104.250162
- Author:
Haonan WU
1
;
Yan TAN
2
Author Information
1. Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai,
2. Great Bay Area Center for Medical Device Evaluation and Inspection of NMPA, Shenzhen,
- Publication Type:Journal Article
- Keywords:
In vitro diagnostic instrument;
instrument family;
performance evaluation;
registration application
- MeSH:
Indicators and Reagents;
Reagent Kits, Diagnostic
- From:
Chinese Journal of Medical Instrumentation
2025;49(5):567-571
- CountryChina
- Language:Chinese
-
Abstract:
Representative models of instruments for in vitro diagnostic (IVD) reagents simplify the performance evaluation of registration. Different from the concept of the US FDA instrument family, the domestic identification of representative models focuses on the risk analysis of instrument differences. However, there are problems such as unclear requirements for the identification of instruments, difficulties in the identification of new technology and high-risk instruments. The performance evaluation of the detection system can be partially simplified by representative models, and representative models can evaluate the performance of non-detection systems. Meanwhile, the comprehensive performance should be evaluated by representative models as conditions. Therefore, according to the analysis, performance evaluations using representative models can guarantee the safety and effectiveness of in vitro diagnostic reagents while promoting the high-quality development of the IVD industry.
