510(k) · Cleared
ClearedARK Methotrexate II Assay
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 Dec 20, 2023 as substantially equivalent to K111904 (Ark Diagnostics, Inc., 2011) after a 166-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Dec 20, 2023
- Review
- 166 days
- Class
- Class U
- Product code
- LAO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932615 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932615 | TDX (R)/TDX (R)FLX (R)Mehtotrexate II | Abbott Laboratories | 1993 | 1 |
| −1 | K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control… | Ark Diagnostics, Inc. | 2011 | — |
| 0 (this device) | K232017 | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | 2023 | — |
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
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 |
|---|---|---|---|
| * | K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…Summary page 5…807.92 (a)(3): Identification of the legally marketed predicate device Predicate Device Name: ARK™ Methotrexate Assay Predicate 510(k) Number: K111904 807.92 (a)(4): Device Description The ARK Methotrexate II Assay is a homogeneous immunoassay based on competition between drug… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 18.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K111904.
How does its category compare?
All LAO devicesLAO Enzyme Immunoassay, Methotrexate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ARK Methotrexate II 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. Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate II Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232017 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232017: ARK Methotrexate II Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232017
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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