# K061249: Axsym Digoxin Iii

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Jun 2, 2006 after 29 days
- Product code: KXT (Enzyme Immunoassay, Digoxin)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953718 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953718: Axsym Digoxin II, Abbott Laboratories (1995) Summary page 1.

## Recalls of this device
- Jul 20, 2007 · Not classified · Z-0064-2008: Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.
- Mar 30, 2007 · Not classified · Z-1202-2007: Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.

## Indications for use
The AxSYM Digoxin III assay is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K061249
Methodology: https://510kreport.com/methodology