# K970883: Cedia Digoxin II

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: May 21, 1997 after 72 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 K882233 (1988). 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)
- K882233: TDX (R) Digoxin NXT, Abbott Laboratories (1988) Summary page 1.

## Indications for use
The CEDIA Digoxin II homogeneous enzyme immunoassay is for the quantitation of digoxin in human serum or plasma using automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure proper therapy. Digoxin is widely prescribed for the treatment of congestive heart failure and various disturbances of cardiac rhythm. Therapeutic use of digoxin improves the strength of myocardial contraction and results in the beneficial effects of increased cardiac output, decreased heart size, decreased venous pressure and decreased blood volume. Digoxin therapy also results in stabilized and slowed ventricular pulse rate. Although the availability of crystalline digoxin has permitted the standardization of drug dosage, therapeutic administration inadvertently, yet frequently, results in toxicity. Importantly, symptoms of digoxin toxicity often mimic the cardiac arthythmias for which the drug was originally prescribed. Studies suggest that up to 25% of all hospitalized patients treated with digoxin experienced some degree of toxicity, and that the mortality rate among toxic patients was more than twice that of nontoxic patients. Digoxin concentrations of 0.9 to 2.0 ng/mL in serum or plasma are normally considered to be therapeutic. Symptoms of human toxicity generally only appear at concentrations above 2.0 ng/mL; however, concentrations as low as 1.4 ng/mL may be toxic for others. Toxicity of digoxin may reflect several factors: a) The drug has a low therapeutic ratio (i.e., a very small difference exists between therapeutic and toxic tissue levels). b) Individuals vary in their response to digoxin. c) Absorption of various tablet forms of digoxin may vary over a two-fold range. d) Susceptibility to digitalis toxicity apparently increases with age. In combination with other clinical data, monitoring serum or plasma levels may provide the physician with useful information to aid in adjusting patient dosage, and achieving optimal therapeutic effect, while avoiding both subtherapeutic and harmful toxic drug levels. The CEDIA Digoxin II Assay performance has not been established with body fluids other than human serum and plasma (Na or Li heparin; Na EDTA). Digoxin-like immunoreactive substances (DLIS) have been identified in blood from patients in renal failure, liver failure, and pregnant women in the third trimester. Studies have established that the presence of DLIS in a sample can result in a false elevation of digoxin when assayed by commercially available immunoassay.

Source page: https://510kreport.com/device/K970883
Methodology: https://510kreport.com/methodology