510(k) · Cleared
ClearedMedtox Oxycodone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtox Diagnostics, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on May 12, 2006 as substantially equivalent to K040411 (Microgenics Corp., 2004) after an 88-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it.
- Decided
- May 12, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K014101 (2002). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 1 generation backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- This deviceK060351 Medtox OxycodoneMedtox Diagnostics, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK220451 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK250741 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
- Descendant · 2 generations on · 0 of its ownK221550 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2023
- Descendant · cites it directly · 0 of its ownK130650 Status DS OxyPrinceton BioMeditech Corp. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009 · cites it directly4descendants
- K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023 · 2 generations on1descendant
- K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026 · 3 generations on0descendants
- K221550Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2023 · 2 generations on0descendants
- K130650Status DS OxyPrinceton BioMeditech Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| −1 | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| 0 (this device) | K060351 | Medtox Oxycodone | Medtox Diagnostics, Inc. | 2006 | — |
| +1 | K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | Medtox Diagnostics, Inc. | 2009 | — |
| +2 | K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | 2023 | 1 |
| +3 | K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026 | — |
| +2 | K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2023 | — |
| +1 | K130650 | Status DS Oxy | Princeton BioMeditech Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K040411 | Dri Oxycodone AssaySummary page 1…DJG Panel: 91 (Toxicology) Predicate Device: DRI Oxycodone Assay, 100 nglmL Cutoff 510(k) Number: K04041 1 Indications for Use The MEDTOX') OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detect… | 2004 |
What descends from it? (6)
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091454 (Medtox Diagnostics, Inc., 2009) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K040411.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription use.
The test detects oxycodone at concentrations of 100 ng/mL and above.
The MEDTOX® OXYCODONE assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060351 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060351: Medtox Oxycodone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060351
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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