# K882233: TDX (R) Digoxin NXT

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 6, 1988 after 40 days
- Product code: KXT (Enzyme Immunoassay, Digoxin)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 7 cite it directly.
0 of 10 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
- K982935: Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator (1998), 1 descendant of its own
- K973112: Elecsys Digoxin (1997), 1 descendant of its own
- K153301: Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (2016), 0 descendants of its own
- K993473: Synchron Systems Drug Calibrator 2 (1999), 0 descendants of its own
- K983151: Immage Immunochemistry System Digoxin (Dig) Reagent (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K882233
Methodology: https://510kreport.com/methodology