510(k) · Cleared
ClearedAxsym Vancomycin II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LEH Radioimmunoassay, Vancomycin
Cleared on May 9, 1996 after a 134-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- May 9, 1996
- Review
- 134 days
- Class
- Class II
- Product code
- LEH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK955851 Axsym Vancomycin IIAbbott Laboratories · 1996
- Descendant · cites it directly · 1 of its ownK072036 Architect Ivancomycin Reagents and Architect Ivancomycin…Biokit, S.A. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK123947 Architect IvancomycinBiokit, S.A. · 2013
- Descendant · cites it directly · 0 of its ownK063045 Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
- Descendant · cites it directly · 0 of its ownK032811 Cedia Vancomycin AssayMicrogenics Corp. · 2003
- Descendant · cites it directly · 0 of its ownK013076 Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin…Beckman Coulter, Inc. · 2001 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K072036Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25…Biokit, S.A. · 2008 · cites it directly1descendant
- K123947Architect IvancomycinBiokit, S.A. · 2013 · 2 generations on0descendants
- K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006 · cites it directly0descendants
- K032811Cedia Vancomycin AssayMicrogenics Corp. · 2003 · cites it directly0descendants
- K013076Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin CalibratorBeckman Coulter, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955851 | Axsym Vancomycin II | Abbott Laboratories | 1996 | — |
| +1 | K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models… | Biokit, S.A. | 2008 | 1 |
| +2 | K123947 | Architect Ivancomycin | Biokit, S.A. | 2013 | — |
| +1 | K063045 | Immulite 2000, Immulite 2500 Vancomycin | Diagnostic Products Corp. | 2006 | — |
| +1 | K032811 | Cedia Vancomycin Assay | Microgenics Corp. | 2003 | — |
| +1 | K013076 | Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator | Beckman Coulter, Inc. | 2001 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | AxSYM Vancomycin assay Named without a submission number |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072036 | Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25… | 2008 | 1 |
| K063045 | Immulite 2000, Immulite 2500 Vancomycin | 2006 | 0 |
| K032811 | Cedia Vancomycin Assay | 2003 | 0 |
| K013076 | Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator | 2001 | 0 |
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?
- Of its descendants, K072036 (Biokit, S.A., 2008) has gone furthest, with 1 descendant of its own.
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 intended use of both assays is for the quantitative determination of vancomycin in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955851 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955851: Axsym Vancomycin II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955851
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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