# K020704: Roche Online Gentamicin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 12, 2002 after 130 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBAS INTEGRA Gentamicin Assay: named in the summary without a submission number

## Recalls of this device
- Oct 7, 2009 · Not classified · Z-0971-2010: A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
- Oct 7, 2009 · Not classified · Z-0970-2010: A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
- Oct 7, 2009 · Not classified · Z-0972-2010: A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.

## Indications for use
The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K020704
Methodology: https://510kreport.com/methodology