510(k) · Cleared
Recalled · Class II · 2016Enzyme Immunoassay, Vancomycin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LEH Radioimmunoassay, Vancomycin
Cleared on May 11, 2006 as substantially equivalent to K954992 (Roche Diagnostic Systems, Inc., 1996) after a 65-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 11, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- LEH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954992 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954992 Roche Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1996
- This deviceK060586 Enzyme Immunoassay, VancomycinRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK152245 ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo) · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K152245ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo) · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954992 | Roche Cobas Integra Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1996 | — |
| 0 (this device) | K060586 | Enzyme Immunoassay, Vancomycin | Roche Diagnostics Corp. | 2006 | — |
| +1 | K152245 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics Operations (Rdo) | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 LEH? 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 LEH device
- #1 K222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH…score 7.0 · 5 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 |
|---|---|---|---|
| * | K954992 | Roche Cobas Integra Reagent CassettesSummary page 1…lassification name: RADIOIMMUNOASSAY, VANCOMYCIN 3) Predicate We claim substantial equivalence to the currently marketed COBAS device INTEGRA Vancomycin (K954992). Continued on next page 510(k) Summary, Contin… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152245 | ONLINE TDM Vancomycin Gen.3 | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 26, 2016 | Class II | Z-2304-2016 | Under Investigation by firm | Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison… |
| Apr 30, 2007 | Not classified | Z-0919-2007 | Other | Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LEH devicesLEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LEH
Too few LEH 510(k)s in any year since 2007 to give a median.
Recalls per year · LEH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEH
14in 2025
MAUDE reports naming product code LEH, 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 | 4 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 0 | 55 |
| 2012 | 0 | — | 0 | 80 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 40 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 2 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 2 | 13 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 1 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060586: Enzyme Immunoassay, Vancomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060586
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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