# K052815: QMS Amikacin Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Nov 1, 2005 after 28 days
- Product code: KLQ (Radioimmunoassay, Amikacin)
- Device class: 2
- Regulation: 21 CFR 862.3035
- 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 K802669 (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)
- K802669: Cybrex Amikacin, Abbott Laboratories (1980) Summary page 1.

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

Source page: https://510kreport.com/device/K052815
Methodology: https://510kreport.com/methodology