Labeling for nucleic-acid-based human leukocyte antigen (HLA) test kits should specify the marker the test is intended to detect, and performance studies for the kits should demonstrate “with a high level of confidence” that the kit performs within the established specifications, FDA recommends in a Nov. 20 draft guidance. The guidance applies to HLA test kits used to match donors and recipients in transfusion and transplantation procedures, and explains the types of validation studies and other information FDA wants to see in 510(k) submissions for the kits. It includes specific recommendations for accuracy studies, precision studies and clinical comparison studies, including pointers in each case for the study design, samples and concordance description.
FDA notes that the science and technology behind HLA test kits has become increasingly complex, and that the highly polymorphic human leukocyte antigen system poses “significant and unique challenges” for...