# K111904: Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Oct 18, 2011 after 105 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: 1 generation back to K932615 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932615: TDX (R)/TDX (R)FLX (R)Mehtotrexate II, Abbott Laboratories (1993)

## Most influential descendants
- K233454: ONLINE TDM Methotrexate (2024), 0 descendants of its own
- K232017: ARK Methotrexate II Assay (2023), 0 descendants of its own

## Indications for use
The ARKTM Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Methotrexate in human serum or plasma on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of methotrexate to help ensure appropriate therapy. The ARKTM Methotrexate Calibrator is intended for use in calibration of the ARK Methotrexate Assay. The ARKTM Methotrexate Control is intended for use in quality control of the ARK Methotrexate Assay. Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate Assay.

Source page: https://510kreport.com/device/K111904
Methodology: https://510kreport.com/methodology