510(k) · Cleared
Recalled · 2006Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LEH Radioimmunoassay, Vancomycin
Cleared on Dec 12, 2001 as substantially equivalent to K955851 (Abbott Laboratories, 1996) after an 89-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.
- Decided
- Dec 12, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- LEH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955851 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955851 Axsym Vancomycin IIAbbott Laboratories · 1996
- This deviceK013076 Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin…Beckman Coulter, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955851 | Axsym Vancomycin II | Abbott Laboratories | 1996 | — |
| 0 (this device) | K013076 | Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator | Beckman Coulter, Inc. | 2001 | — |
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 |
|---|---|---|---|
| * | K955851 | Axsym Vancomycin IISummary page 1…calibrator (21 CFR § 862.3200) 4.0 Predicate Device(s): Beckman Coulter | Predicate Manufactursr | chkét ' SYNCHRON® Systems AxSYM® Vancamyein 1l Abbott Laborataries, K955851 Vancomyain (VANC) Assay Inc.* Reagent and Calibrator *Abbott Laboratories, Inc., Abbott Park, IL 5.0 Description: The SYNCHRO… | 1996 |
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 |
|---|---|---|---|---|
| Mar 30, 2006 | Not classified | Z-0886-06 | Other | Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K955851.
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 SYNCHRON® Systems Vancomycin (VANC) Reagent, in conjunction with the SYNCHRON® Systems Vancomycin Calibrator set, is intended for the quantitative determination of vancomycin concentration in human serum and plasma on SYNCHRON Systems by turbidimetric immunoassay.
The SYNCHRON® Systems Vancomycin Calibrator, used in conjunction with SYNCHRON® Vancomycin Reagent, is intended for use on the SYNCHRON Systems fogt(\e' FaJibrfg%Q%ncomycin.
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/K013076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013076: Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013076
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026