FDA Product Code GKA: Abnormal Hemoglobin Quantitation

Abnormal hemoglobin variants cause significant morbidity in affected populations worldwide. FDA product code GKA covers abnormal hemoglobin quantitation systems used in hematology.

These systems — using HPLC, electrophoresis, or capillary electrophoresis — separate and quantify hemoglobin variants including HbS, HbC, HbA2, and fetal hemoglobin, enabling diagnosis of sickle cell disease, beta-thalassemia, and other hemoglobinopathies.

GKA devices are Class II medical devices, regulated under 21 CFR 864.7415 and reviewed by the FDA Hematology panel.

Leading manufacturers include Sebia, Bio-Rad and Bio-Rad Laboratories, Inc..