FDA Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices
标准简介
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices[附网盘链接]是FDA发布的FDA标准，适用于美国。标准截图
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标准文档说明
标准文档类型为Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
63 Content and Format for Abbreviated 64 510(k)s for Early Growth Response 1 65 (EGR1) Gene Fluorescence In-Situ 66 Hybridization (FISH) Test System for 67 Specimen Characterization Devices 68
69 Guidance for Industry and Food and Drug 70 Administration Staff 71 72 This guidance represents the current thinking of the Food and Drug Administration (FDA 73 or Agency) on this topic. It does not establish any rights for any person and is not binding 74 on FDA or the public. You can use an alternative approach if it satisfies the requirements 75 of the applicable statutes and regulations. To discuss an alternative approach, contact the 76 FDA staff responsible for this guidance as listed on the title page. 77 78 I. Introduction 79
80 FDA is issuing this guidance to provide industry and agency staff with recommendations for 81 the suggested format and content of an Abbreviated 510(k) submission for early growth 82 response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen 83 characterization devices and recommendations for addressing certain labeling issues relevant 84 to the review process specific to these devices. 85 86 FDA's guidance documents, including this guidance, do not establish legally enforceable 87 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and 88 should be viewed only as recommendations, unless specific regulatory or statutory 89 requirements are cited. The use of the word should in Agency guidances means that 90 something is suggested or recommended, but not required. 91 92 II. Scope 93 The scope of this document is limited to the devices identified in 21 CFR 864.1870 as: 94 An early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test 95 system for specimen characterization is a device intended to detect the EGR1 probe target on 96 chromosome 5q in bone marrow specimens from patients with acute myeloid leukemia 97 (AML) or myelodysplastic syndrome (MDS). The assay results are intended to be 98 interpreted only by a qualified pathologist or cytogeneticist. These devices do not include 1
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