# K082953: Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Dec 22, 2008 after 80 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
Longest line of descent: 1 generation back to K023058 (2002). 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)
- K023058: QMS Digoxin Reagent System on the Abbott Aeroset System, Seradyn (2002) Summary page 1.

## Indications for use
The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy. The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K082953
Methodology: https://510kreport.com/methodology