# K011920: Emit 2000 Digoxin Assay, Model OSR4H229

- Pathway: 510(k) (Special)
- Applicant: Syva Co., Dade Behring, Inc.
- Decided: Jul 2, 2001 after 12 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Emit® 2000 Digoxin Assay: named in the summary without a submission number

## Indications for use
The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

Source page: https://510kreport.com/device/K011920
Methodology: https://510kreport.com/methodology