Devices descending from K951361
21 later devices reach Dca 2000 System for Hemoglobin A1C through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | 2018 | 0 | — |
| +1 | K091711 | S- Test Hemoglobin Alc (HBA1C), Model RC0023 | Alfa Wassermann Diagnostic Technologies, Inc. | 2009 | 0 | — |
| +1 | K073309 | Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis Reagent | Horiba Abx | 2008 | 0 | — |
| +1 | K071466 | Dca Vantage, Model 5075 | Siemens Medical Solutions Diagnostics | 2007 | 8 | 1 |
| +1 | K050574 | Afinion Hbalc | Axis-Shield Poc AS | 2005 | 9 | — |
| +2 | K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017 | 2 | 2 |
| +2 | K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | 2017 | 0 | — |
| +2 | K142664 | URight Hemoglobin A1c system, FORA A1c System | Taidoc Technology Corporation | 2016 | 0 | — |
| +2 | K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | 2015 | 6 | — |
| +2 | K130014 | A1C Gear System | Sakae Corporation | 2014 | 1 | — |
| +2 | K110056 | Afinion Analyzer | Axis-Shield Poc AS | 2011 | 8 | — |
| +2 | K082275 | Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023 | Infopia Co, Ltd. | 2010 | 2 | — |
| +3 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024 | 0 | — |
| +3 | K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023 | 0 | — |
| +3 | K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | 2020 | 0 | — |
| +3 | K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | 2019 | 0 | — |
| +3 | K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent… | Skyla Corporation H.S.P.B | 2018 | 0 | — |
| +3 | K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | 2015 | 0 | — |
| +3 | K142789 | A1c iGear System | Sakae Corporation | 2014 | 0 | — |
| +3 | K121366 | Hemocue HBA1C 501 | Infopia Co, Ltd. | 2012 | 1 | — |
| +4 | K141750 | Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System | Infopia Co, Ltd. | 2014 | 0 | — |