# K932615: TDX (R)/TDX (R)FLX (R)Mehtotrexate II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 14, 1993 after 43 days
- Product code: LAO (Enzyme Immunoassay, Methotrexate)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K111904: Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran (2011), 2 descendants of its own
- K233454: ONLINE TDM Methotrexate (2024), 0 descendants of its own
- K232017: ARK Methotrexate II Assay (2023), 0 descendants of its own

## Recalls of this device
- Mar 20, 2007 · Not classified · Z-1056-2007: Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.

Source page: https://510kreport.com/device/K932615
Methodology: https://510kreport.com/methodology