# K050419: QMS Vancomycin

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Apr 1, 2005 after 42 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 K813218 (1981). 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)
- K813218: TDX Vancomycin, Abbott Laboratories (1981) Summary page 1.

## Recalls of this device
- Dec 20, 2007 · Not classified · Z-1102-2008: False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

## Indications for use
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.

Source page: https://510kreport.com/device/K050419
Methodology: https://510kreport.com/methodology