PDJ · Class II · 21 CFR 862.1373

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 Siemens Healthcare Diagnostics, Inc., Shanghai Medconn Medical Technology Co., Ltd. and Abbott Laboratories.

26
Total
25
Cleared
263d
Avg days
2013
Since
Growing category - 4 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 389d recently vs 240d historically

FDA 510(k) Cleared Hemoglobin A1c Test System Devices (Product Code PDJ)

26 devices
1–24 of 26
Cleared Jan 06, 2026
Medconn 8K Glycated Hemoglobin Test System
K252749
Shanghai Medconn Medical Technology Co., Ltd.
Chemistry · 130d
Cleared Oct 03, 2025
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
K250073
Tosoh Bioscience, Inc.
Chemistry · 266d
Cleared Jun 20, 2025
Medconn Glycated Hemoglobin Test system
K242911
Shanghai Medconn Medical Technology Co., Ltd.
Chemistry · 269d
Cleared Sep 12, 2024
Hipro Glycosylated Hemoglobin (HbA1c) Test System
K220999
Shijiazhuang Hipro Biotechnology Co., Ltd.
Chemistry · 892d
Cleared Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
K200904
Tosoh Bioscience, Inc.
Chemistry · 486d
Cleared Jul 02, 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
K200256
Siemens Healthcare Diagnostics, Inc.
Chemistry · 515d
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Jan 16, 2019
HbA1c Advanced
K182651
Beckman Coulter Ireland, Inc.
Chemistry · 114d
Cleared Nov 29, 2018
Afinion HbA1c Dx on Afinion 2
K182988
Alere Technologies AS
Chemistry · 31d
Cleared Jul 13, 2018
Dimension Hemoglobin A1c Assay
K173909
Siemens Healthcare Diagnostics, Inc.
Chemistry · 203d
Cleared Jul 12, 2018
SEKURE HbA1c Assay
K173206
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 283d
Cleared May 07, 2018
Afinion HbA1c Dx
K180296
Alere Technologies AS
Chemistry · 94d
Cleared Feb 07, 2018
CAPILLARYS Hb A1c
K171861
Sebia
Chemistry · 230d
Cleared Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771
Siemens Healthcare Diagnostics, Inc.
Chemistry · 173d
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654
Abbott Laboratories
Chemistry · 434d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255
Abbott Laboratories
Chemistry · 392d

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 510(k) Review Time - PDJ Product Code

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 →