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Kim, Kim, Lee, Oh, Woo, Kim, and Min: Guidelines for the Performance Evaluation of In-Vitro Diagnostic Test for the Detection of Norovirus Infection in Korea
Original Article

Lab Med Online 2017;7(1):1-6.

Published online: 17 January 2017

DOI: https://doi.org/10.3343/lmo.2017.7.1.1

Guidelines for the Performance Evaluation of In-Vitro Diagnostic Test for the Detection of Norovirus Infection in Korea

Jayoung Kim, M.D.1, Hyun Soo Kim, M.D.2, , Sunwha Lee, M.D.3, Seoung Hwan Oh, M.D.4, Kwang-Sook Woo, M.D.5, Seong-Youl Kim, Ph.D6, Eui Kee Min, B.S.7

1Department of Laboratory Medicine, International St.Mary's hospital, Catholic Kwandong University College of Medicine, Incheon, Korea

2Department of Laboratory Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea

3Seegene Medical Foundation, Seoul, Korea

4Department of Laboratory Medicine, Inje University College of Medicine, Busan, Korea

5Department of Laboratory Medicine, Dong-A University College of Medicine, Busan, Korea

6Department of Academic Support Affair, Seegene Inc., Seoul, Korea

7Standardia Diagnostics, Inc., Yongin, Korea

Corresponding author: Hyun Soo Kim Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keunjaebong-gil, Hwaseong 18450, Korea Tel: +82-31-8086-2775, Fax: +82-31-8086-2789, E-mail: hskim0901@empas.com

Received 19 January 20163 March 2016       Accepted 4 March 2016

Copyright © 2017 The Korean Society for Laboratory Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Norovirus is a leading cause of epidemic and sporadic acute gastroenteritis worldwide. Rapid and accurate detection of norovirus is essential for the prevention and control of norovirus outbreaks. The purpose of this study was to propose and develop a process for establishing appropriate standardized guidelines for the approval and evaluation of in vitro diagnostic medical devices (IVDD) for norovirus detection in Korea based on the related laws, regulations, and guidelines of USA, Europe, and Korea. We expect that this study could be used for diagnostic test standardization and the approval and evaluation of domestic norovirus diagnostic devices. We also expect the results will contribute to industrial expansion and public health promotion.

Keywords: Norovirus, In-Vitro Diagnostic Device, Evaluation, Guideline

REFERENCES

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Table 1.
Product classification of norovirus detection devices
  미국 유럽 한국
Classification Medical device Medical device 의료기기
Law/Regulation FDA Act, FD&C Act, Safe Medical Device Act Guide to the Implementation of Directives Based on 의료기기법
    new approach and global approach  
Detailed guideline Code of Federal Regulation IVDMDD (98/79/EC) 의료기기법 시행규칙
Organization FDA OIR National health authority /Third part organization 식품의약품안전처 의료기기안전국
Class Class II General IVD (Others) 3 등급
Authorization FDA approved, 510(k) submission EC declaration of Conformity 허가

Abberations: OIR, the Office of In Vitro Diagnostics and Radiological Health; PMN, Premarket Notification; IVDMDD, In Vitro Diagnostic Medical Device Directive.

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