510(k) · Cleared
ClearedLzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)
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, 2014 as substantially equivalent to K120763 (Lin-Zhi International, Inc., 2012) after a 50-day review. Its family tree reaches back 4 generations to 2002. 3 later devices descend from it.
- Decided
- Jun 13, 2014
- Review
- 50 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014101 (2002). 3 later devices descend from it, 1 citing it directly.
- 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 deviceK141055 Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML)…Lin-Zhi International, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK150502 DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone…Microgenics Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK231752 ARK Hydrocodone AssayArk Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK173195 DRI Hydrocodone AssayMicrogenics Corporation · 2018
Most influential descendants
Showing 3 of 3 · See all- K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ControlsMicrogenics Corporation · 2015 · cites it directly2descendants
- K231752ARK Hydrocodone AssayArk Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K173195DRI Hydrocodone AssayMicrogenics Corporation · 2018 · 2 generations on0descendants
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) | K141055 | Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls… | Lin-Zhi International, Inc. | 2014 | — |
| +1 | K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | Microgenics Corporation | 2015 | — |
| +2 | K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023 | — |
| +2 | K173195 | DRI Hydrocodone Assay | Microgenics Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K120763 | Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone…Summary page 2…Marketed Predicate Device(s) The LZI H-ydrocodone Enzyme Immunoassay (ELA) is substantially equivalent to the Lin-Zhi International, Inc. Oxycodone Enzyme Immunoassay (k120763) manufactured by Lin-Zhi International, Inc. The LZI Hydrocodone Enzyme Immunoassay is identical or similar to its predicate in t… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | 2015 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K150502 (Microgenics Corporation, 2015) has gone furthest, with 2 descendants of its own.
- 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. 2014, 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 Hydrocodone Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at the cutoff values of 100 and 300 ng/mL when calibrated against hydrocodone. 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…
Read the full statement (215 words)
The LZI Hydrocodone Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of
hydrocodone in human urine at the cutoff values of 100 and 300 ng/mL when calibrated against hydrocodone. 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 GCMS and LCMS or (2) permitting laboratories to establish
quality control procedures.
The LZI Hydrocodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-
quantitative calibration of the LZI Hydrocodone Enzyme Immunoassay at the cutoff value of 100 and 300 ng/mL.
The LZI Hydrocodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the
precision of the LZI Hydrocodone Enzyme Immunioassay at the cutoff value of 100 and 300 ng/mL.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in
order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LCIMS)
is the preferred confirmatory method). 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 as stated in the FDA summary.
https://510kreport.com/device/K141055 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141055: Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141055
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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