510(k) · Cleared
Recalled · Class III · 2014Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems
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 Dec 22, 2008 as substantially equivalent to K040316 (Microgenics Corp., 2004) after a 256-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 22, 2008
- Review
- 256 days
- Class
- Class II
- Product code
- DJG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001178 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 1 generation backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- This deviceK081008 Buprenorphine Enzyme Immunoassay, Calibrators and Controls for…Lin-Zhi International, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK090844 Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators…Lin-Zhi International, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK253082 LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −2 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −1 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| 0 (this device) | K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter… | Lin-Zhi International, Inc. | 2008 | — |
| +1 | K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls | Lin-Zhi International, Inc. | 2009 | — |
| +2 | K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K040316 | Cedia Buprenorphine AssaySummary page 2…stems Legally Marketed Predicate Device(s) The LZI Buprenorphine Enzyme Immunoassay (EIA) is substantially equivalent to the CEDIA® Buprenorphine Assay (K040316) manufactured by Microgenics Corporation. LZI's Buprenorphine Enzyme Immunoassay is identical or similar to its predicate in term… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2014 | Class III | Z-1270-2014 | Packaging | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL). |
| Oct 3, 2013 | Class III | Z-0386-2014 | Under Investigation by firm | Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090844 (Lin-Zhi International, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K040316.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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, when used in conjunction with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers, is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 10 ng/mL. The Norbuprenorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and…
Read the full statement (183 words)
The Lin-Zhi International (LZI) Buprenorphine Enzyme Immunoassay, when used in conjunction with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers, is intended for the qualitative and semi-quantitative determination of norbuprenorphine (buprenorphine metabolite) in human urine, at a cutoff value of 10 ng/mL.
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 with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers.
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 with Beckman Coulter® Synchron LX®, CX®, and UniCel® DxC automated clinical system analyzers.
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/K081008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081008: Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081008
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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