Devices descending from K964020
9 later devices reach Axsym CA 125 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K042731 | Architect CA 125 II Assay | Fujirebio Diagnostics,Inc. | 2004 | 8 | — |
| +2 | K072939 | HE4 Eia, Model: 404-10 US | Fujirebio Diagnostics,Inc. | 2008 | 7 | — |
| +3 | K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | Fujirebio Diagnostics,Inc. | 2015 | 0 | — |
| +3 | K103676 | Fujirebio Diagnostics Tumor Marker Control | Fujirebio Diagnostics,Inc. | 2011 | 0 | — |
| +3 | K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54… | Fujirebio Diagnostics,Inc. | 2010 | 4 | — |
| +4 | K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5 | Roche Diagnostics | 2012 | 2 | — |
| +4 | K101809 | Fujirebio Diagnostics Tumor Marker Control Model 108-20 | Fujirebio Diagnostics,Inc. | 2010 | 0 | — |
| +5 | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016 | 1 | — |
| +6 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025 | 0 | — |