510(k) · Cleared
ClearedDRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · DJG Enzyme Immunoassay, Opiates
Cleared on Oct 9, 2015 as substantially equivalent to K141055 (Lin-Zhi International, Inc., 2014) after a 225-day review. Its family tree reaches back 5 generations to 2002. 2 later devices descend from it.
- Decided
- Oct 9, 2015
- Review
- 225 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K014101 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 4 generations backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- 3 generations backK050733 Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and ControlsLin-Zhi International, Inc. · 2005
- 2 generations backK120763 Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone…Lin-Zhi International, Inc. · 2012
- 1 generation backK141055 Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML)…Lin-Zhi International, Inc. · 2014
- This deviceK150502 DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone…Microgenics Corporation · 2015
- Descendant · cites it directly · 0 of its ownK231752 ARK Hydrocodone AssayArk Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK173195 DRI Hydrocodone AssayMicrogenics Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| −4 | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| −3 | 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 | — |
| −1 | K141055 | Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls… | Lin-Zhi International, Inc. | 2014 | — |
| 0 (this device) | K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls | Microgenics Corporation | 2015 | — |
| +1 | K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023 | — |
| +1 | K173195 | DRI Hydrocodone Assay | Microgenics Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141055 | Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)Summary page 5…lly Marketed Predicate Device(s) The DRI® Hydrocodone Assay is substantially equivalent to the predicate Lin-Zhi International, Inc., LZI Hydrocodone Enzyme Immunoassay (K141055). The DRI® Hydrocodone Assay, calibrators, and controls are identical or similar to the predicate in terms of intended use, metho… | 2014 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K231752 (Ark Diagnostics, Inc., 2023) has gone furthest, with 0 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. 2015, 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?
DRI® Hydrocodone Assay The DRI® Hydrocodone Assay is intended for the qualitative and semi-quantitative detection and estimation of Hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of specimen for confirmation by a confirmatory method such as LC-MS/MS or GC-MS and permitting laboratories to establish quality control measures.…
Read the full statement (191 words)
DRI® Hydrocodone Assay
The DRI® Hydrocodone Assay is intended for the qualitative and semi-quantitative detection and estimation of Hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of specimen for confirmation by a confirmatory method such as LC-MS/MS or GC-MS and permitting laboratories to establish quality control measures.
This assay provides a preliminary analytical test result. A more specific alternative chemical method must be used in order to confirm an analytical result. Gas chromatography/mass spectrometry (GC/MS) and Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
DRI® Hydrocodone Calibrators
The DRI® Hydrocodone Assay Calibrators are intended for the calibration of the DRI® Hydrocodone Assay. For In Vitro Diagnostic Use Only.
DRI® Hydrocodone Controls
The DRI® Hydrocodone Controls are unassayed quality control material intended for use in the DRI Hydrocodone Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. For In Vitro Diagnostics Use Only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150502: DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150502
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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