510(k) · Cleared
Recalled · 2007TDX (R)/TDX (R)FLX (R)Mehtotrexate II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LAO Enzyme Immunoassay, Methotrexate
Cleared on Jul 14, 1993 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 14, 1993
- Review
- 43 days
- Class
- Class U
- Product code
- LAO
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK932615 TDX (R)/TDX (R)FLX (R)Mehtotrexate IIAbbott Laboratories · 1993
- Descendant · cites it directly · 2 of its ownK111904 Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark…Ark Diagnostics, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK233454 ONLINE TDM MethotrexateRoche Diagnostics Operations · 2024
- Descendant · 2 generations on · 0 of its ownK232017 ARK Methotrexate II AssayArk Diagnostics, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K111904Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…Ark Diagnostics, Inc. · 2011 · cites it directly2descendants
- K233454ONLINE TDM MethotrexateRoche Diagnostics Operations · 2024 · 2 generations on0descendants
- K232017ARK Methotrexate II AssayArk Diagnostics, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932615 | TDX (R)/TDX (R)FLX (R)Mehtotrexate II | Abbott Laboratories | 1993 | — |
| +1 | K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control… | Ark Diagnostics, Inc. | 2011 | — |
| +2 | K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | 2024 | — |
| +2 | K232017 | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LAO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LAO device
- #1 K233454 ONLINE TDM Methotrexatescore 7.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark… | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2007 | Not classified | Z-1056-2007 | Other | Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111904 (Ark Diagnostics, Inc., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LAO devicesLAO Enzyme Immunoassay, Methotrexate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LAO
Too few LAO 510(k)s in any year since 2007 to give a median.
Recalls per year · LAO
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LAO
1in 2025
MAUDE reports naming product code LAO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 5 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K932615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932615: TDX (R)/TDX (R)FLX (R)Mehtotrexate II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932615
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026