肌酸激酶测定试剂盒技术审评规范要点概述

Overview of the Evaluation Guidance of the Creatine kinase Assay Kit

肌酸激酶是心脑血管慢性损伤的重要指标,目前肌酸激酶测定试剂盒尚无行业标准发布,为了规范肌酸激酶测定试剂盒注册申报和技术审评工作,特制定肌酸激酶测定试剂(盒)产品技术审评规范。本文从适用范围、命名组成、主要技术指标、临床要求和标签、说明书等方面对该规范进行了简要概述,帮助注册申报人更好的把握产品的技术要点,有效的指导注册申报工作。

Creatine kinase is an important indicator of chronic cardiovascular and cerebrovascular injury, there is no industry standard release at present. The Evaluation Guidance of the Creatine kinase Assay Kit was released by Beijing drug administration in order to standardize the premarket registration and technical review of creatine kinase assay kit, This paper gives a brief introduction to the guidance about the intend use, the name and composition, the main technical indicators, the clinical requirements and label instructions. We hope it wil help the manufacturer grasp of the key points of the product and help the registration application effectively.