FDA Product Code JPK: Mixture, Hematology Quality Control

Accurate hematology analyzers require regular performance verification. FDA product code JPK covers hematology quality control mixtures used to verify analyzer performance.

These stabilized blood cell-based or synthetic materials are run on hematology analyzers to confirm that instrument results for cell counts and indices fall within established acceptable ranges, ensuring the reliability of patient results reported by the laboratory.

JPK devices are Class II medical devices, regulated under 21 CFR 864.8625 and reviewed by the FDA Hematology panel.

Leading manufacturers include Beckman Coulter, Inc., Bio-Rad and Streck.