# K013076: Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 12, 2001 after 89 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955851 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955851: Axsym Vancomycin II, Abbott Laboratories (1996) Summary page 1.

## Recalls of this device
- Mar 30, 2006 · Not classified · Z-0886-06: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K013076
Methodology: https://510kreport.com/methodology