Hemoglobin A1c Test System
FDA product code PDJ · Class II (moderate risk) · 21 CFR 862.1373 · Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
25510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Tosoh Bioscience Inc 3
- Bio-Rad Laboratories, Inc. 3
- Siemens Healthcare Diagnostics, Inc. 3
- Abbott Laboratories 2
- Roche Diagnostics Operations (Rdo) 2
- Sebia 2
- Alere Technologies AS 2
- Shanghai Medconn Medical Technology Co., Ltd. 2
- Roche Diagnostics Operations, Inc. 1
- Ortho-Clinical Diagnostics 1
- Arkray Factory, Inc. 1
- Sekisui Diagnostics P.E.I., Inc. 1
- Beckman Coulter Ireland, Inc. 1
- Shijiazhuang Hipro Biotechnology Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test SystemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 01/06/2026SE |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | Tosoh Bioscience, Inc. | 10/03/2025SE |
| K242911 | Medconn Glycated Hemoglobin Test systemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 06/20/2025SE |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test SystemPDJ · Traditional | Shijiazhuang Hipro Biotechnology Co., Ltd. | 09/12/2024SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 08/05/2021SE |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssayPDJ · Special | Siemens Healthcare Diagnostics, Inc. | 07/02/2021SE |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | Roche Diagnostics Operations (Rdo) | 03/26/2020SE |
| K182651 | HbA1c AdvancedPDJ · Traditional | Beckman Coulter Ireland, Inc. | 01/16/2019SE |
| K182988 | Afinion HbA1c Dx on Afinion 2PDJ · Special | Alere Technologies AS | 11/29/2018SE |
| K173909 | Dimension Hemoglobin A1c AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2018SE |
| K173206 | SEKURE HbA1c AssayPDJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 07/12/2018SE |
| K180296 | Afinion HbA1c DxPDJ · Traditional | Alere Technologies AS | 05/07/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | Sebia | 02/07/2018SE |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/04/2017SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | Sebia | 09/12/2017SE |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80PDJ · Traditional | Arkray Factory, Inc. | 06/29/2017SE |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ · Traditional | Roche Diagnostics Operations (Rdo) | 12/19/2016SE |
| K161687 | D-10 Hemoglobin A1c ProgramPDJ · Traditional | Bio-Rad Laboratories, Inc. | 10/14/2016SE |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator PackPDJ · Traditional | Bio-Rad Laboratories, Inc. | 12/09/2015SE |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…PDJ · Traditional | Ortho Clinical Diagnostics | 06/04/2015SE |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsPDJ · Traditional | Abbott Laboratories | 05/22/2015SE |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0PDJ · Traditional | Bio-Rad Laboratories, Inc. | 03/24/2015SE |
| K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsPDJ · Traditional | Abbott Laboratories | 02/28/2014SE |
| K131580 | Automated Gylcohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 01/23/2014SE |
| K121610 | Cobas C 501 Tina-Quant HBA1CDX GEN.3 AssayPDJ · Traditional | Roche Diagnostics Operations | 08/08/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2703-2026 Class II | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI… | Siemens Healthcare Diagnostics, Inc. | 06/08/2026Open, Classified |
| Z-1657-2026 Class II | Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same… | Siemens Healthcare Diagnostics, Inc. | 02/23/2026Open, Classified |
| Z-1628-2023 Class II | VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of…Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis | Ortho-Clinical Diagnostics, Inc. | 04/17/2023Open, Classified |
| Z-1456-2022 Class II | REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL…There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using… | Abbott Laboratories | 06/09/2022Open, Classified |
| Z-1455-2022 Class II | REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL…There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using… | Abbott Laboratories | 06/09/2022Open, Classified |
| Z-1454-2022 Class II | REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL…There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using… | Abbott Laboratories | 06/09/2022Open, Classified |
| Z-0929-2022 Class II | Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality… | Siemens Healthcare Diagnostics, Inc. | 02/09/2022Open, Classified |
| Z-2192-2020 Class II | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556…The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the… | Abbott Diagnostics Technologies AS | 03/23/2020Open, Classified |
| Z-0396-2017 Class II | COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number….Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant… | Roche Diagnostics Operations, Inc. | 10/04/2016Terminated |