510(k) · Cleared
Recalled · Class II · 2019ONLINE TDM Vancomycin Gen.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Operations (Rdo) · LEH Radioimmunoassay, Vancomycin
Cleared on Jan 8, 2016 as substantially equivalent to K060586 (Roche Diagnostics Corp., 2006) after a 151-day review. Its family tree reaches back 2 generations to 1996. It has been recalled 2 times.
- Decided
- Jan 8, 2016
- Review
- 151 days
- Class
- Class II
- Product code
- LEH
- Recalls
- 2
- 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 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 |
|---|---|---|---|
| * | K060586 | Enzyme Immunoassay, VancomycinSummary page 4…Clinical Toxicology Test Systems, Class II Product Codes LEH, 21 CFR § 862.3950 Predicate Devices ONLINE TDM Vancomycin, K060586 Establishment 1823260, Roche Diagnostics Operations Inc. Registration Submission Type/Num. : K152245… | 2006 |
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 |
|---|---|---|---|---|
| Jul 23, 2019 | Class II | Z-0042-2020 | Under Investigation by firm | Inaccurately Low Sample Results |
| Jul 23, 2019 | Class II | Z-0043-2020 | Under Investigation by firm | Inaccurately Low Sample Results |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LEH devicesLEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
In vitro test for the quantitative determination of vancomycin in serum and plasma on Roche/Hitachi cobas c systems.
A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. 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/K152245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152245: ONLINE TDM Vancomycin Gen.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152245
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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