美国FDA 指导原则 上市前通知建议(510(K))提交用于输血和移植中供体和受者匹配的基于核酸的人白细胞抗原(人类白细胞抗原)检测试剂盒 行业指南 英文原版.pdfVIP

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 Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@, or from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research July 2015 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. RECOMMENDATIONS FOR THE PREPARATION OF THE HLA TEST KIT PREMARKET NOTIFICATION (510(k)) SUBMISSION 2 A. Intended Use 2 B. Device Design 3 C. Performance Studies 4 D. Software 8 E. Validation of Instrumentation 9 F. Labeling 9 G. Additional Considerations 10 IV. REFERENCES 11 i Contains Nonbinding Recommendations Recommendations for Premarket Notif