# K032279: Online TDM Amika

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 10, 2003 after 78 days
- Product code: KLP (Amikacin Serum Assay)
- 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: 2 generations back to K954992 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991597: Cobas Integra Amikacin Mab, Roche Diagnostics Corp. (1999) Summary page 1.

## Indications for use
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K032279
Methodology: https://510kreport.com/methodology