510(k) · Cleared
ClearedARK Hydrocodone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ark Diagnostics, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Nov 9, 2023 as substantially equivalent to K150502 (Microgenics Corporation, 2015) after a 147-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Nov 9, 2023
- Review
- 147 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K014101 (2002). No later device cites it as a predicate yet.
- Root · 6 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 5 generations backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- 4 generations backK050733 Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005
- 3 generations backK120763 Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone…Lin-Zhi International, Inc. · 2012
- 2 generations backK141055 Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML)…Lin-Zhi International, Inc. · 2014
- 1 generation backK150502 DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone…Microgenics Corporation · 2015
- This deviceK231752 ARK Hydrocodone AssayArk Diagnostics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| −5 | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| −4 | K050733 | Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls | Lin-Zhi International, Inc. | 2005 | — |
| −3 | K120763 | Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi… | Lin-Zhi International, Inc. | 2012 | — |
| −2 | K141055 | Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls… | Lin-Zhi International, Inc. | 2014 | — |
| −1 | K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | Microgenics Corporation | 2015 | — |
| 0 (this device) | K231752 | ARK Hydrocodone 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsSummary page 4…Opiate Test System (91) 807.92 (a)(3): Identification of the Legally Marketed Predicate Device DRI Hydrocodone Assay (K150502) ARK Diagnostics, Inc. – 510(k) Summary Page 05-1 of 05-14 ARK Hydrocodone Assay 80… | 2015 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K150502.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The ARK Hydrocodone Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass…
Read the full statement (140 words)
The ARK Hydrocodone Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures.
The ARK Hydrocodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed positive analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231752: ARK Hydrocodone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231752
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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