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..
FDA 510(k) Cleared Hemoglobin A1c Test System Devices (Product Code PDJ)
About Product Code PDJ - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code PDJ since 2013, with 25 receiving FDA clearance (average review time: 263 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PDJ have taken an average of 389 days to reach a decision - up from 240 days historically. Manufacturers should account for longer review timelines in current project planning.
PDJ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →