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 Tosoh Bioscience, Inc., Bio-Rad Laboratories, Inc. and Siemens Healthcare Diagnostics, Inc..

27
Total
26
Cleared
262d
Avg days
2013
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 224d recently vs 269d historically

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

27 devices
1–24 of 27
Cleared Oct 02, 2026
H100Plus Hemoglobin Testing System
K260468
Shenzhen Lifotronic Technology Co., Ltd.
Chemistry · 232d
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 Sep 12, 2017
CAPI 3 Hb A1c
K171537
Sebia
Chemistry · 110d
Cleared Jun 29, 2017
ADAMS A1c HA-8180V, CALIBRATOR 80
K162822
Arkray Factory, Inc.
Chemistry · 265d
Cleared Dec 19, 2016
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
K160571
Roche Diagnostics Operations (Rdo)
Chemistry · 294d
Cleared Oct 14, 2016
D-10 Hemoglobin A1c Program
K161687
Bio-Rad Laboratories, Inc.
Chemistry · 119d
Cleared Dec 09, 2015
D-100 HbA1c, D-100 HbA1c Calibrator Pack
K151321
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
K142595
Ortho-Clinical Diagnostics
Chemistry · 262d
Cleared May 22, 2015
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654
Abbott Laboratories
Chemistry · 434d
Cleared Mar 24, 2015
VARIANT II TURBO HbA1c Kit - 2.0
K142448
Bio-Rad Laboratories, Inc.
Chemistry · 203d
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

27 total 510(k) submissions under product code PDJ since 2013, with 26 receiving FDA clearance (average review time: 262 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 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 224 days to reach a decision - down from 269 days historically, suggesting improved FDA processing for this classification.

PDJ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →