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 Bio-Rad Laboratories, Inc., Siemens Healthcare Diagnostics, Inc. 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
Cleared
Jan 06, 2026
Medconn 8K Glycated Hemoglobin Test System
Shanghai Medconn Medical Technology Co., Ltd.
Chemistry
130d
Cleared
Oct 03, 2025
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
Tosoh Bioscience, Inc.
Chemistry
266d
Cleared
Jun 20, 2025
Medconn Glycated Hemoglobin Test system
Shanghai Medconn Medical Technology Co., Ltd.
Chemistry
269d
Cleared
Sep 12, 2024
Hipro Glycosylated Hemoglobin (HbA1c) Test System
Shijiazhuang Hipro Biotechnology Co., Ltd.
Chemistry
892d
Cleared
Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
Tosoh Bioscience, Inc.
Chemistry
486d
Cleared
Jul 02, 2021
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
Siemens Healthcare Diagnostics, Inc.
Chemistry
515d
Cleared
Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
Roche Diagnostics Operations (Rdo)
Chemistry
146d
Cleared
Jan 16, 2019
HbA1c Advanced
Beckman Coulter Ireland, Inc.
Chemistry
114d
Cleared
Nov 29, 2018
Afinion HbA1c Dx on Afinion 2
Alere Technologies AS
Chemistry
31d
Cleared
Jul 13, 2018
Dimension Hemoglobin A1c Assay
Siemens Healthcare Diagnostics, Inc.
Chemistry
203d
Cleared
Jul 12, 2018
SEKURE HbA1c Assay
Sekisui Diagnostics P.E.I., Inc.
Chemistry
283d
Cleared
May 07, 2018
Afinion HbA1c Dx
Alere Technologies AS
Chemistry
94d
Cleared
Feb 07, 2018
CAPILLARYS Hb A1c
Sebia
Chemistry
230d
Cleared
Dec 04, 2017
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Siemens Healthcare Diagnostics, Inc.
Chemistry
173d
Cleared
Oct 14, 2016
D-10 Hemoglobin A1c Program
Bio-Rad Laboratories, Inc.
Chemistry
119d
Cleared
Dec 09, 2015
D-100 HbA1c, D-100 HbA1c Calibrator Pack
Bio-Rad Laboratories, Inc.
Chemistry
205d
Cleared
Jun 04, 2015
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
Ortho-Clinical Diagnostics
Chemistry
262d
Cleared
May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
Abbott Laboratories
Chemistry
434d
Cleared
Mar 24, 2015
VARIANT II TURBO HbA1c Kit - 2.0
Bio-Rad Laboratories, Inc.
Chemistry
203d
Cleared
Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
Abbott Laboratories
Chemistry
392d
Not Cleared
May 23, 2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
Roche Diagnostics
Chemistry
59d
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 →