# K023058: QMS Digoxin Reagent System on the Abbott Aeroset System

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn
- Decided: Oct 24, 2002 after 41 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer, Boehringer Mannheim Corp. (1995). Our reading of the summary gave K953239, FDA’s number for Boehringer Mannheim/Hitachi 917 Analyzer (Boehringer Mannheim Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Roche Tina-quant Digoxin”. Kept off the family tree.

## Most influential descendants
- K082953: Architect Idigoxin and Architect Idigoxin Calibrators, Models 1P32-25 and IP32-01 (2008), 0 descendants of its own

## Indications for use
The SERADYN QMS DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma on the Abbott AEROSET System. Digoxin is a potent cardiac glycoside widely prescribed for the treatment of patients suffering from congestive heart failure, as well as some types of cardiac arrhythmias. Digoxin intoxication is a common and serious problem in the clinical setting. This is, in part, a result of the fact that cardiac glycosides have a low therapeutic ratio (a very small difference between therapeutic and tissue toxic levels). Coupled with the narrow therapeutic range is a marked patient variability in response to the same dosage of drug, often resulting in unpredictable serum drug levels. Intoxication symptoms are often indistinguishable from the original condition for which the drug was prescribed. It may not be immediately apparent whether the patient has been under or overdosed. Monitoring serum digoxin levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.

Source page: https://510kreport.com/device/K023058
Methodology: https://510kreport.com/methodology