510(k) · Cleared
Recalled · 2007Online TDM Tobramycin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · KLB Radioimmunoassay, Tobramycin
Cleared on Jun 9, 2006 as substantially equivalent to K964457 (Roche Diagnostic Systems, Inc., 1997) after a 72-day review. Its family tree reaches back 2 generations to 1978. It has been recalled 2 times.
- Decided
- Jun 9, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- KLB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K780563 (1978). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K780563 | Single Vial Lactate | Boehringer Mannheim Corp. | 1978 | — |
| −1 | K964457 | Roche Cobas Ibtegra Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1997 | 2 |
| 0 (this device) | K060853 | Online TDM Tobramycin | Roche Diagnostics Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
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 KLB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K964457 | Roche Cobas Ibtegra Reagent CassettesSummary page 1…lassification name: RADIOIMMUNOASSAY, TOBRAMYCIN 3) Predicate We claim substantial equivalence to the currently marketed COBAS device INTEGRA Tobramycin (K964457). Continued on next page… | 1997 |
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 |
|---|---|---|---|---|
| Apr 5, 2007 | Not classified | Z-0918-2007 | Other | 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, Online TDM phenytoin, Online DAT cocaine… |
| Apr 5, 2007 | Not classified | Z-0917-2007 | Other | 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, Online TDM phenytoin, Online DAT cocaine… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All KLB devicesKLB Radioimmunoassay, Tobramycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLB
FDA has decided no KLB device since 2007.
Median 510(k) review, days · KLB
Too few KLB 510(k)s in any year since 2007 to give a median.
Recalls per year · KLB
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLB
1in 2024
MAUDE reports naming product code KLB, 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 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060853 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060853: Online TDM Tobramycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060853
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026