FDA Product Code PDJ: Hemoglobin A1c Test System

HbA1c measurement is the gold standard for long-term glycemic monitoring in diabetes. FDA product code PDJ covers hemoglobin A1c test systems used in clinical laboratories and at the point of care.

These assays measure the percentage of hemoglobin with glucose attached, reflecting average blood glucose levels over the preceding 2-3 months. HbA1c is used for diabetes diagnosis, treatment monitoring, and assessment of long-term glycemic control.

PDJ devices are Class II medical devices, regulated under 21 CFR 862.1373 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Tosoh Bioscience, Inc., Shanghai Medconn Medical Technology Co., Ltd. and Siemens Healthcare Diagnostics, Inc..