# K060586: Enzyme Immunoassay, Vancomycin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 11, 2006 after 65 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954992 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954992: Roche Cobas Integra Reagent Cassettes, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K152245: ONLINE TDM Vancomycin Gen.3 (2016), 0 descendants of its own

## Recalls of this device
- May 26, 2016 · Class II · Z-2304-2016: Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that stat
- Apr 30, 2007 · Not classified · Z-0919-2007: Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MB

## Indications for use
The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Source page: https://510kreport.com/device/K060586
Methodology: https://510kreport.com/methodology