Devices descending from DEN130002
23 later devices reach Tina-Quant HBA1C Gen. 2 Test System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Operations (Rdo) | 2020 | 0 | — |
| +1 | K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | Roche Diagnostics Operations (Rdo) | 2016 | 1 | 1 |
| +1 | K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry… | Ortho Clinical Diagnostics | 2015 | 0 | 2 |
| +1 | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories, Inc. | 2015 | 6 | — |
| +1 | K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls | Abbott Laboratories | 2014 | 4 | 3 |
| +1 | K131580 | Automated Gylcohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2014 | 3 | 2 |
| +1 | K121610 | Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay | Roche Diagnostics Operations | 2013 | 2 | — |
| +2 | K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | 2018 | 0 | — |
| +2 | K173206 | SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. | 2018 | 0 | — |
| +2 | K180296 | Afinion HbA1c Dx | Alere Technologies AS | 2018 | 1 | 1 |
| +2 | K171861 | CAPILLARYS Hb A1c | Sebia | 2018 | 0 | — |
| +2 | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017 | 1 | 1 |
| +2 | K171537 | CAPI 3 Hb A1c | Sebia | 2017 | 0 | — |
| +2 | K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Arkray Factory, Inc. | 2017 | 0 | — |
| +2 | K161687 | D-10 Hemoglobin A1c Program | Bio-Rad Laboratories, Inc. | 2016 | 0 | — |
| +2 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015 | 4 | — |
| +2 | K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | Abbott Laboratories | 2015 | 0 | 2 |
| +3 | K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026 | 0 | — |
| +3 | K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | 2025 | 0 | — |
| +3 | K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024 | 0 | — |
| +3 | K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021 | 0 | 2 |
| +3 | K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | 2019 | 0 | — |
| +3 | K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | 2018 | 0 | 1 |