FDA Product Code JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Under FDA product code JKA, blood collection tubes, vials, and serum separator systems are cleared for the collection and processing of clinical specimens.

These devices include evacuated tubes with various additives — anticoagulants, gels, clot activators — that preserve specimen integrity for specific laboratory tests. Serum separators use a gel barrier to separate serum from clot after centrifugation, simplifying sample processing.

JKA devices are Class II medical devices, regulated under 21 CFR 862.1675 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Becton, Dickinson and Company, Bd Becton Dickinson Vacutainer Systems Preanalytic and Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd..