510(k) · Cleared
ClearedBuprenorphine Enzyme Immunoassay with Norbuprenorphine 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 Jul 30, 2009 as substantially equivalent to K081008 (Lin-Zhi International, Inc., 2008) after a 125-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jul 30, 2009
- Review
- 125 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001178 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 2 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 1 generation backK081008 Buprenorphine Enzyme Immunoassay, Calibrators and Controls for…Lin-Zhi International, Inc. · 2008 · Recalled
- This deviceK090844 Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators…Lin-Zhi International, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK253082 LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −2 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −1 | K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter… | Lin-Zhi International, Inc. | 2008 | 2 |
| 0 (this device) | K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls | Lin-Zhi International, Inc. | 2009 | — |
| +1 | K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron…Summary page 2…orphine Enzyme Inumunoassay (EIA) is substantially equivalent to the LZI Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems (k081008) manufactured by Lin-Zhi International, Inc. LZI's Buprenorphine Enzyme Immunoassay is identical or similar to its predicate in t… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | 2026 | 0 |
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 9 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K253082 (Lin-Zhi International, Inc., 2026) 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. 2009, 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 Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 5 and 10 ng/mL. The assay is designed for prescription use in clinics and clinical chemistry laboratories with a number of automated clinical chemistry analyzers. The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as…
Read the full statement (163 words)
The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 5 and 10 ng/mL. The assay is designed for prescription use in clinics and clinical chemistry laboratories with a number of automated clinical chemistry analyzers.
The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay.
The Norbuprenorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay.
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. Chromatography/mass spectrometry (GC/MS or LC/MS) 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/K090844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090844: Buprenorphine Enzyme Immunoassay with Norbuprenorphine 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/K090844
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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