510(k) · Cleared
ClearedQMS Tobramycin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seradyn, Inc. · LCR Fluorescent Immunoassay, Tobramycin
Cleared on Jul 21, 2006 as substantially equivalent to K802668 (Abbott Laboratories, 1980) after a 101-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Jul 21, 2006
- Review
- 101 days
- Class
- Class II
- Product code
- LCR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K802668 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK802668 Cybrex TobramycinAbbott Laboratories · 1980
- This deviceK060998 QMS TobramycinSeradyn, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802668 | Cybrex Tobramycin | Abbott Laboratories | 1980 | — |
| 0 (this device) | K060998 | QMS Tobramycin | Seradyn, Inc. | 2006 | — |
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 LCR? 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 |
|---|---|---|---|
| * | K802668 | Cybrex TobramycinSummary page 1…d in monitoring levels of tobramycin to help ensure appropriate therapy. LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED Abbott TDxf-TDxFLx Tolbramycin assay (k802668) DESCRIPTION OF DEVICE The QMS® Tobramycin assay system is a homogeneous assay utilizing particle agglutination technology and… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K802668.
How does its category compare?
All LCR devicesLCR Fluorescent Immunoassay, Tobramycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCR
FDA has decided no LCR device since 2007.
Median 510(k) review, days · LCR
Too few LCR 510(k)s in any year since 2007 to give a median.
Recalls per year · LCR
No recall names LCR since 2007.
Adverse event reports per year · LCR
1in 2024
MAUDE reports naming product code LCR, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 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 QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060998 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060998: QMS Tobramycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060998
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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