510(k) · Cleared
ClearedLZI Oxycodone III Enzyme Immunoassay
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 Sep 17, 2020 as substantially equivalent to K120763 (Lin-Zhi International, Inc., 2012) after a 58-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Sep 17, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014101 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 3 generations backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- 2 generations backK050733 Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005
- 1 generation backK120763 Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone…Lin-Zhi International, Inc. · 2012
- This deviceK202007 LZI Oxycodone III Enzyme ImmunoassayLin-Zhi International, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| −3 | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K202007 | LZI Oxycodone III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K120763 | Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Summary page 5…e Immunoassay Legally Marketed Predicate Device(s) The LZI Oxycodone III Enzyme Immunoassay (EIA) is substantially equivalent to the LZI Oxycodone Assay (k120763) manufactured by Lin-Zhi International, Inc. (LZI). The LZI Oxycodone III Enzyme Immunoassay is identical or similar to its predi… | 2012 |
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 18 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K120763.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 LZI Oxycodone III Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of oxycodone in human urine at the cutoff values of 100 ng/mL and 300 ng/mL when calibrated against oxycodone. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for…
Read the full statement (142 words)
The LZI Oxycodone III Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of oxycodone in human urine at the cutoff values of 100 ng/mL and 300 ng/mL when calibrated against oxycodone. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS or LC/MS, or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
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/K202007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202007: LZI Oxycodone III Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202007
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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