Product code PDJ
- Device name
- Hemoglobin A1c Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1373
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | 2025-10-03 |
| K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | 2025-06-20 |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024-09-12 |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2021-08-05 |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Operations (Rdo) | 2020-03-26 |
| K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | 2019-01-16 |
| K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | 2018-11-29 |
| K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 |
| K173206 | SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. | 2018-07-12 |
| K180296 | Afinion HbA1c Dx | Alere Technologies AS | 2018-05-07 |
| K171861 | CAPILLARYS Hb A1c | Sebia | 2018-02-07 |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 |
| K171537 | CAPI 3 Hb A1c | Sebia | 2017-09-12 |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Arkray Factory, Inc. | 2017-06-29 |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | Roche Diagnostics Operations (Rdo) | 2016-12-19 |
| K161687 | D-10 Hemoglobin A1c Program | Bio-Rad Laboratories, Inc. | 2016-10-14 |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015-12-09 |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II | Ortho Clinical Diagnostics | 2015-06-04 |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | Abbott Laboratories | 2015-05-22 |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories, Inc. | 2015-03-24 |
| K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS | Abbott Laboratories | 2014-02-28 |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | Tosoh Bioscience, Inc. | 2014-01-23 |
| K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY | Roche Diagnostics Operations | 2013-08-08 |
| DEN130002 | TINA-QUANT HBA1C GEN. 2 TEST SYSTEM | Roche Diagnostics | 2013-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740208622 | ARCHITECT | Abbott GmbH | 2026-05-15 |
| 00380740208639 | Alinity | Abbott GmbH | 2026-05-15 |
| 04562185406207 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LA | TOSOH CORPORATION | 2026-01-05 |
| 04562185405286 | GR01 HbA1c Elution Buffer No. 3 | TOSOH CORPORATION | 2026-01-05 |
| 04562185405279 | GR01 HbA1c Elution Buffer No. 2 | TOSOH CORPORATION | 2026-01-05 |
| 04562185405262 | GR01 HbA1c Elution Buffer No. 1 | TOSOH CORPORATION | 2026-01-05 |
| 04562185405255 | TSKgel GR01 HbA1c Column | TOSOH CORPORATION | 2026-01-05 |
| 04562185404944 | 290 Sample Loader | TOSOH CORPORATION | 2026-01-05 |
| 04562185404937 | 90 Sample Loader | TOSOH CORPORATION | 2026-01-05 |
| 04562185404920 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | TOSOH CORPORATION | 2026-01-05 |
| 04562185400571 | HbA1c Diluting Solution | TOSOH CORPORATION | 2026-01-05 |
| 06935784430016 | BioHermes Automated Glycohemoglobin Analyzer | Wuxi Biohermes Bio & Medical Technology Co.,Ltd. | 2022-01-04 |
| 07613336157824 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics GmbH | 2020-04-14 |
| 07070060014555 | Afinion HbA1c Dx | Abbott Diagnostics Technologies AS | 2019-05-31 |
| 00630414220505 | Atellica CH A1c_E | Siemens Healthcare Diagnostics Inc. | 2019-03-14 |
| 00630414002859 | ADVIA Chemistry Enzymatic Hemoglobin A1c | Siemens Healthcare Diagnostics Inc. | 2018-07-06 |
| 00630414002866 | ADVIA Chemistry Enzymatic Hemoglobin A1c | Siemens Healthcare Diagnostics Inc. | 2018-07-06 |
| 00630414002880 | ADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment | Siemens Healthcare Diagnostics Inc. | 2018-07-06 |
| 04987486015093 | ELUENT 80A | ARKRAY USA, INC. | 2018-02-08 |
| 04987486015109 | ELUENT 80B | ARKRAY USA, INC. | 2018-02-08 |
| 04987486015116 | ELUENT 80CV | ARKRAY USA, INC. | 2018-02-08 |
| 03607360025154 | CAPI 3 Hb A1c | SEBIA | 2018-01-24 |
| 04987486015123 | HEMOLYSIS WASHING SOLUTION 80H | ARKRAY USA, INC. | 2017-12-08 |
| 04015630942787 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics GmbH | 2016-12-21 |
| 03610520506547 | VARIANT II TURBO | BIO-RAD LABORATORIES, INC. | 2016-10-07 |
| 04560189283169 | TSKgel G8 Variant HSi | TOSOH CORPORATION | 2016-09-24 |
| 04015630934560 | Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application | Roche Diagnostics GmbH | 2016-09-23 |
| 00847817016004 | D-100 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00380740102722 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 10758750030729 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-10 |