510(k) · Cleared
ClearedDridau Opiate Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DJG Enzyme Immunoassay, Opiates
Cleared on Jun 20, 2001 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jun 20, 2001
- Review
- 65 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK011150 Dridau Opiate AssayMicrogenics Corp. · 2001
- Descendant · cites it directly · 6 of its ownK020368 Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog #…Lin-Zhi International, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK120761 Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000…Lin-Zhi International, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK141803 Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK110298 Opiate Enzyme ImmunoassayLin-Zhi International, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK203527 Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K020368Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit)Lin-Zhi International, Inc. · 2002 · cites it directly6descendants
- K120761Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…Lin-Zhi International, Inc. · 2012 · 2 generations on2descendants
- K141803Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 2015 · 3 generations on1descendant
- K110298Opiate Enzyme ImmunoassayLin-Zhi International, Inc. · 2011 · 2 generations on1descendant
- K203527Immunalysis Tapentadol Urine HEIALmmunalysis Corporation · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011150 | Dridau Opiate Assay | Microgenics Corp. | 2001 | — |
| +1 | K020368 | Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021… | Lin-Zhi International, Inc. | 2002 | — |
| +2 | K120761 | Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators… | Lin-Zhi International, Inc. | 2012 | — |
| +3 | K141803 | Immunalysis Tramadol Urine Enzyme Immunoassay | Immunalysis Corporation | 2015 | — |
| +2 | K110298 | Opiate Enzyme Immunoassay | Lin-Zhi International, Inc. | 2011 | — |
| +4 | K203527 | Immunalysis Tapentadol Urine HEIA | Lmmunalysis Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K020368 (Lin-Zhi International, Inc., 2002) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K011150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011150: Dridau Opiate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011150
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026