510(k) · Cleared
ClearedOnline TDM Amika
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · KLP Amikacin Serum Assay
Cleared on Oct 10, 2003 as substantially equivalent to K991597 (Roche Diagnostics Corp., 1999) after a 78-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Oct 10, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- KLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954992 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KLP? 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 |
|---|---|---|---|
| * | K991597 | Cobas Integra Amikacin MabSummary page 1…Classification name: Amikacin serum assay 3) Predicate We claim substantial equivalence to the currently marketed COBAS device INTEGRA Amikacin (K99 1597). Continued on next page… | 1999 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All KLP devicesKLP Amikacin Serum Assay: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLP
FDA has decided no KLP device since 2007.
Median 510(k) review, days · KLP
Too few KLP 510(k)s in any year since 2007 to give a median.
Recalls per year · KLP
No recall names KLP since 2007.
Adverse event reports per year · KLP
2in 2023
MAUDE reports naming product code KLP, 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 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 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 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032279: Online TDM Amika.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032279
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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