# K060709: Multigent Gentamicin

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Jun 15, 2006 after 91 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- 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 K904226 (1990). 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)
- K904226: 'Tdxflx Analyzer, Abbott Laboratories (1990) Summary page 1.

## Indications for use
The Multigent Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K060709
Methodology: https://510kreport.com/methodology