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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.