# K152245: ONLINE TDM Vancomycin Gen.3

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Jan 8, 2016 after 151 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: 2 generations back to K954992 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060586: Enzyme Immunoassay, Vancomycin, Roche Diagnostics Corp. (2006) Summary page 4.

## Recalls of this device
- Jul 23, 2019 · Class II · Z-0042-2020: Inaccurately Low Sample Results
- Jul 23, 2019 · Class II · Z-0043-2020: Inaccurately Low Sample Results

## Indications for use
In vitro test for the quantitative determination of vancomycin in serum and plasma on Roche/Hitachi cobas c systems. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. 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/K152245
Methodology: https://510kreport.com/methodology