# K233454: ONLINE TDM Methotrexate

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations
- Decided: Feb 20, 2024 after 123 days
- Product code: LAO (Enzyme Immunoassay, Methotrexate)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932615 (1993). 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)
- K111904: Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran, Ark Diagnostics, Inc. (2011) Summary page 4.

## Indications for use
ONLINE TDM Methotrexate is an in vitro test for the quantitative determination of methotrexate in human serum and plasma on cobas c systems. The determination of methotrexate is used for monitoring levels of methotrexate to ensure appropriate therapy.

Source page: https://510kreport.com/device/K233454
Methodology: https://510kreport.com/methodology