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..
FDA 510(k) Cleared Abnormal Hemoglobin Quantitation Devices (Product Code GKA)
About Product Code GKA - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code GKA since 1981, with 23 receiving FDA clearance (average review time: 194 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
GKA devices are reviewed by the Hematology panel. Browse all Hematology devices →