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 July 2015

GUIDANCE DOCUMENT

• Docket Number: FDA-2013-D-1358
• Issued by: Center for Biologics Evaluation and Research

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).

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