# K963158: Abbott Axsym Digitoxin (Modify)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 10, 1996 after 46 days
- Product code: LFM (Enzyme Immunoassay, Digitoxin)
- Device class: 2
- Regulation: 21 CFR 862.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TDx/TDxFLx Digitoxin assay: named in the summary without a submission number

## Indications for use
The intended use of both assays is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate).

Source page: https://510kreport.com/device/K963158
Methodology: https://510kreport.com/methodology