510(k) · Cleared
ClearedRapidone-Oxy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on Mar 20, 2002 after a 97-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Mar 20, 2002
- Review
- 97 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 3 citing it directly.
- This deviceK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- Descendant · cites it directly · 16 of its ownK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- Descendant · 2 generations on · 6 of its ownK060351 Medtox OxycodoneMedtox Diagnostics, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK050733 Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005
- Descendant · 3 generations on · 5 of its ownK120763 Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone…Lin-Zhi International, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K040411Dri Oxycodone AssayMicrogenics Corp. · 2004 · cites it directly16descendants
- K060351Medtox OxycodoneMedtox Diagnostics, Inc. · 2006 · 2 generations on6descendants
- K050733Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005 · 2 generations on6descendants
- K120763Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Lin-Zhi International, Inc. · 2012 · 3 generations on5descendants
- K091454Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| +1 | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| +2 | K060351 | Medtox Oxycodone | Medtox Diagnostics, Inc. | 2006 | — |
| +2 | 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 | — |
| +3 | K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | Medtox Diagnostics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 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 |
|---|---|---|---|
| * | — | RDS opiate test products Named without a submission number |
What descends from it? (21)
See all 213 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?
- Of its descendants, K040411 (Microgenics Corp., 2004) has gone furthest, with 16 descendants of its own.
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?
‘RapidOne-OXY" Test is a one-step, lateral flow immunoassay for the detection of oxycodone in urine. ‘RapidOne-Oxy” Test is intended for the qualitative detection of oxycodone in human urine at 100 ng/ml. ‘RapidOne-OXY’ Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative…
Read the full statement (143 words)
‘RapidOne-OXY" Test is a one-step, lateral flow immunoassay for the detection of oxycodone in urine.
‘RapidOne-Oxy” Test is intended for the qualitative detection of oxycodone in human urine at 100 ng/ml.
‘RapidOne-OXY’ Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS.)
‘RapidOune-OXY* Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. 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.
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/K014101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014101: Rapidone-Oxy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014101
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026