510(k) · Cleared
Recalled · 2007QMS Vancomycin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seradyn, Inc. · LEH Radioimmunoassay, Vancomycin
Cleared on Apr 1, 2005 as substantially equivalent to K813218 (Abbott Laboratories, 1981) after a 42-day review. Its family tree reaches back 1 generation to 1981. It has been recalled once.
- Decided
- Apr 1, 2005
- Review
- 42 days
- Class
- Class II
- Product code
- LEH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813218 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK813218 TDX VancomycinAbbott Laboratories · 1981 · Recalled
- This deviceK050419 QMS VancomycinSeradyn, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813218 | TDX Vancomycin | Abbott Laboratories | 1981 | 1 |
| 0 (this device) | K050419 | QMS Vancomycin | Seradyn, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K813218 | TDX VancomycinSummary page 1…nt of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy. LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED TDX® Vancomycin (K813218) DESCRIPTION OF DEVICE The QMS Vancomycin assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based… | 1981 |
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 |
|---|---|---|---|---|
| Dec 20, 2007 | Not classified | Z-1102-2008 | Device Design | False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
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 QMS® Vancomycin assay is intended for the quantitative determination of
vancomycin in human serum or plasma on the Hitachi 717 analyzer.
The results obtained are used in the diagnosis and treatment of vancomycin
overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050419: QMS Vancomycin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050419
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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