# K060998: QMS Tobramycin

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Jul 21, 2006 after 101 days
- Product code: LCR (Fluorescent Immunoassay, Tobramycin)
- Device class: 2
- Regulation: 21 CFR 862.3900
- 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 K802668 (1980). 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)
- K802668: Cybrex Tobramycin, Abbott Laboratories (1980) Summary page 1.

## Indications for use
The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K060998
Methodology: https://510kreport.com/methodology