FDA (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation
标准简介
(510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation[附网盘链接]是于之前发布的FDA标准，适用于US。标准截图
![(510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation[附网盘链接]](/img/20210914103545qiitf.jpg)
标准文档说明
标准文档类型为(510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation[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
Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation _____________________________________________________________________________ Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this as listed on the title page. I. INTRODUCTION This guidance provides recommendations to submitters (hereafter referred to as “you”) and FDA reviewers in preparing and reviewing premarket notification submissions (hereafter referred to as “510(k) submission” or “510(k)”) for human leukocyte antigen (HLA) in vitro diagnostic (IVD) device test kits. This guidance applies specifically to nucleic acid-based HLA test kits used for the matching of donors and recipients in transfusion and transplantation, whether testing is for a single locus or for multiple loci simultaneously, for which the premarket submission to FDA will be a 510(k). Although this guidance applies specifically to 510(k) submissions for HLA test kits, some of the recommendations in this guidance may also be applicable to human neutrophil antigen (HNA) and human platelet antigen (HPA) test kits. We recommend that you consult the Office of Blood Research and Review (OBRR) in FDA’s Center for Biologics Evaluation and Research (CBER) for specific guidance regarding premarket submission requirements for HNA and HPA test kits. This guidance provides detailed information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s and used for the matching of donors and recipients in transfusion and transplantation. More specifically, the document addresses the types of studies and other information that FDA recommends be used in designing and conducting studies for validation of nucleic acid-based HLA test kits and preparing a 510(k) submission. This guidance finalizes the draft guidance of the same title dated November 2013 (78 FR 69693, November 20, 2013).
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