510(k) · Cleared
Recalled · 2009Roche Online Gentamicin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LCD Enzyme Immunoassay, Gentamicin
Cleared on Jul 12, 2002 after a 130-day review. The FDA summary names its predicate without a number. It has been recalled 3 times.
- Decided
- Jul 12, 2002
- Review
- 130 days
- Class
- Class II
- Product code
- LCD
- Recalls
- 3
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCD device
- #1 K243500 ARCHITECT iGentamicinscore 9.9 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | COBAS INTEGRA Gentamicin Assay Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2009 | Not classified | Z-0971-2010 | Other | 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 | Other | 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 | Other | A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LCD devicesLCD Enzyme Immunoassay, Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCD
Too few LCD 510(k)s in any year since 2007 to give a median.
Recalls per year · LCD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCD
2in 2024
MAUDE reports naming product code LCD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 4 | 3 |
| 2010 | 0 | — | 1 | 4 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020704: Roche Online Gentamicin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020704
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026