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KMID : 1142220210160010001
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 1 p.1 ~ p.6
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Study on Development of Performance Evaluation Test Method for Pregnancy Test Kit
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kwak Joung-In
Choi Bo-Ram
Kim Ji-Eun
Lee Seung-Ro
Park Ki-Dae
Park Ki-Sook
Jeong Ho-Sang
Lee Eung-Tae
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Abstract
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In vitro diagnostic medical devices are becoming increasingly important as they are recognized to play a key role in preventing the increase in public medical expenditures and expanding patients' treatment opportunities through disease prevention and personalized medical services. As the industry gradually grows, new regulations for in vitro diagnostic medical devices are being introduced at home and abroad, and it is necessary to establish an evaluation basis for scientific and safe quality control to cope with this. Among them, a guideline was developed to prepare the basis for safety management by developing an analytical performance evaluation test method for user safety for the items of pregnancy diagnosis test kit, which is a representative medical device for in-vitro diagnosis in Korea. The performance evaluation test items were derived by investigating and analyzing the domestic and foreign standard standards and guidance of the pregnancy diagnosis test kit, and a test method for the test items was developed. In order to secure scientific validity and reliability of research results, a consultative body of experts from industry, academia, and research institutes was formed, and a collection of information on performance evaluation was prepared by collecting opinions after consulting and reviewing the appropriateness of performance test items. It is expected to be used for product development approval and review, quality control, and performance evaluation by preparing an analytical performance evaluation information collection for the pregnancy diagnosis test device developed through this study.
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KEYWORD
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Pregnancy test kit, Performance Evaluation, Reagents for self testing, Reagents for In vitro Diagnostics, IVD
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