510(k) · Cleared
ClearedArk Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · LAO Enzyme Immunoassay, Methotrexate
Cleared on Oct 18, 2011 as substantially equivalent to K932615 (Abbott Laboratories, 1993) after a 105-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Oct 18, 2011
- Review
- 105 days
- Class
- Class U
- Product code
- LAO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932615 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932615 TDX (R)/TDX (R)FLX (R)Mehtotrexate IIAbbott Laboratories · 1993 · Recalled
- This deviceK111904 Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark…Ark Diagnostics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK233454 ONLINE TDM MethotrexateRoche Diagnostics Operations · 2024
- Descendant · cites it directly · 0 of its ownK232017 ARK Methotrexate II AssayArk Diagnostics, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932615 | TDX (R)/TDX (R)FLX (R)Mehtotrexate II | Abbott Laboratories | 1993 | 1 |
| 0 (this device) | K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control… | Ark Diagnostics, Inc. | 2011 | — |
| +1 | K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | 2024 | — |
| +1 | K232017 | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932615 | TDX (R)/TDX (R)FLX (R)Mehtotrexate II | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K233454 (Roche Diagnostics Operations, 2024) has gone furthest, with 0 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. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111904: Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111904
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026