# K842280: TDX Digitoxin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 16, 1984 after 69 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.
18 later devices descend from it; 1 cites it directly.
0 of 19 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
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents (1997), 17 descendants of its own
- K980996: Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) (1998), 9 descendants of its own
- K031879: Cobas Integra Carbon Dioxide Assay (2003), 8 descendants of its own
- K032377: Roche Diagnostics Hitachi Bicarbonate Liquid (2003), 2 descendants of its own
- K183555: GEM Premier ChemSTAT (2019), 1 descendant of its own

Source page: https://510kreport.com/device/K842280
Methodology: https://510kreport.com/methodology