# K060853: Online TDM Tobramycin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 9, 2006 after 72 days
- Product code: KLB (Radioimmunoassay, Tobramycin)
- Device class: 2
- Regulation: 21 CFR 862.3900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K780563 (1978). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964457: Roche Cobas Ibtegra Reagent Cassettes, Roche Diagnostic Systems, Inc. (1997) Summary page 1.

## Recalls of this device
- Apr 5, 2007 · Not classified · Z-0918-2007: Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, On
- Apr 5, 2007 · Not classified · Z-0917-2007: Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, On

## Indications for use
The ONLINE TDM Tobramycin assay is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in human plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K060853
Methodology: https://510kreport.com/methodology