510(k) · Cleared
ClearedDri Oxycodone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · LAS Drug Specific Control Materials
Cleared on May 27, 2004 as substantially equivalent to K014101 (American Bio Medica Corp., 2002) after a 99-day review. Its family tree reaches back 1 generation to 2002. 16 later devices descend from it.
- Decided
- May 27, 2004
- Review
- 99 days
- Class
- Class I
- Product code
- LAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K014101 (2002). 16 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- This deviceK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- Descendant · cites it directly · 6 of its ownK060351 Medtox OxycodoneMedtox Diagnostics, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK050733 Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK120763 Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone…Lin-Zhi International, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK141055 Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML)…Lin-Zhi International, Inc. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K060351Medtox OxycodoneMedtox Diagnostics, Inc. · 2006 · cites it directly6descendants
- K050733Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005 · cites it directly6descendants
- K120763Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Lin-Zhi International, Inc. · 2012 · 2 generations on5descendants
- K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009 · 2 generations on4descendants
- K141055Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)Lin-Zhi International, Inc. · 2014 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| 0 (this device) | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| +1 | K060351 | Medtox Oxycodone | Medtox Diagnostics, Inc. | 2006 | — |
| +1 | K050733 | Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls | Lin-Zhi International, Inc. | 2005 | — |
| +2 | K120763 | Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi… | Lin-Zhi International, Inc. | 2012 | — |
| +2 | K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | Medtox Diagnostics, Inc. | 2009 | — |
| +3 | K141055 | Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls… | Lin-Zhi International, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 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 LAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K014101 | Rapidone-Oxy TestSummary page 3…te Device(s): The information provided in this pre-market notification demonstrates that the DRI® Oxycodone Assay is substantially equivalent to the Rapidone-Oxy Test (K014101) manufactured by American Bio Medica Corp (Columbia, MD) for its general intended use. Device Subject Device Predicate Device (K… | 2002 |
What descends from it? (16)
See all 164 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?
How does its category compare?
All LAS devicesLAS Drug Specific Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LAS
Too few LAS 510(k)s in any year since 2007 to give a median.
Recalls per year · LAS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LAS
No MAUDE report names LAS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DRI® Oxycodone Assay is intended to be used for the qualitative and semi-quanilitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screenlng procedure to detect oxycodone in human urine. The assay provides only a preliminary analytical test resuilt. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas…
Read the full statement (130 words)
The DRI® Oxycodone Assay is intended to be used for the qualitative and semi-quanilitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screenlng procedure to detect oxycodone in human urine.
The assay provides only a preliminary analytical test resuilt. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine.
The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040411 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040411: Dri Oxycodone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040411
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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