# K032811: Cedia Vancomycin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Nov 24, 2003 after 76 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- 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 K955851 (1996). 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)
- K955851: Axsym Vancomycin II, Abbott Laboratories (1996) Summary page 1.

## Indications for use
The CEDIA@Vancomycin Assay is a homogenous enzyme immunoassay intended for in vitro diagnostic use in the quantitative determination of vancomycin in human serum or plasma for the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K032811
Methodology: https://510kreport.com/methodology