# K953718: Axsym Digoxin II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 25, 1995 after 47 days
- Product code: KXT (Enzyme Immunoassay, Digoxin)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061249: Axsym Digoxin Iii (2006), 0 descendants of its own

## Recalls of this device
- May 22, 2008 · Not classified · Z-0297-2009: AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Digoxin II assay file.

Source page: https://510kreport.com/device/K953718
Methodology: https://510kreport.com/methodology