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 and Bio-Rad Laboratories, Inc..
List of Abnormal Hemoglobin Quantitation devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Abnormal Hemoglobin Quantitation devices (product code GKA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Hematology FDA review panel. Browse all Hematology devices →