510(k) · Cleared
ClearedOxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jun 13, 2005 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
- Jun 13, 2005
- 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, 1 citing it directly.
- Root · 2 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 1 generation backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- This deviceK050733 Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK120763 Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone…Lin-Zhi International, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK141055 Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML)…Lin-Zhi International, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK150502 DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone…Microgenics Corporation · 2015
- Descendant · 4 generations on · 0 of its ownK231752 ARK Hydrocodone AssayArk Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK202007 LZI Oxycodone III Enzyme ImmunoassayLin-Zhi International, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120763Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Lin-Zhi International, Inc. · 2012 · cites it directly5descendants
- K141055Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)Lin-Zhi International, Inc. · 2014 · 2 generations on3descendants
- K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsMicrogenics Corporation · 2015 · 3 generations on2descendants
- K231752ARK Hydrocodone AssayArk Diagnostics, Inc. · 2023 · 4 generations on0descendants
- K202007LZI Oxycodone III Enzyme ImmunoassayLin-Zhi International, Inc. · 2020 · 2 generations on0descendants
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) | K050733 | Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls | Lin-Zhi International, Inc. | 2005 | — |
| +1 | 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 | — |
| +3 | K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | Microgenics Corporation | 2015 | — |
| +4 | K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023 | — |
| +2 | K202007 | LZI Oxycodone III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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…etary Name: LZI Oxycodone Assay Legally Marketed Predicate Device(s) The LZI Oxycodone Enzyme Immunoassay is substantially equivalent to the DRI® Oxycodone Assay (K04041 1) manufactured by DRI/Microgenics Corp. LZI's Oxycodone Enzyme Immunoassay is identical or similar to its predicate in terms of i… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120763 | Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone… | 2012 | 5 |
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 3 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, K120763 (Lin-Zhi International, Inc., 2012) has gone furthest, with 5 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 Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semi-quantitative analyses of oxycodone and its metabolite, oxymorphone in human urine. The Oxycodone calibrators are used to calibrate the oxycodone enzyme immunoassay for drug detection in human urine. The Oxycodone controls are used to validate the assay. The assay provides a simple and rapid…
Read the full statement (161 words)
The Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semi-quantitative analyses of oxycodone and its metabolite, oxymorphone in human urine.
The Oxycodone calibrators are used to calibrate the oxycodone enzyme immunoassay for drug detection in human urine. The Oxycodone controls are used to validate the assay.
The assay provides a simple and rapid analytical screening procedure to detect oxycodone and its metabolite in human urine.
The assay is designed for professional use with a number of automated clinical chemistry analyzers. Performance data submitted was obtained using the Hitachi 717 analyzer.
The Oxycodone Enzyme Immunoassay provides only a preliminary analytical test result. 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 consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050733: Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050733
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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