510(k) · Cleared
ClearedLZI Buprenorphine II Enzyme Immunoassay
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 Jan 16, 2026 as substantially equivalent to K090844 (Lin-Zhi International, Inc., 2009) after a 115-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jan 16, 2026
- Review
- 115 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001178 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 3 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 2 generations backK081008 Buprenorphine Enzyme Immunoassay, Calibrators and Controls for…Lin-Zhi International, Inc. · 2008 · Recalled
- 1 generation backK090844 Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators…Lin-Zhi International, Inc. · 2009
- This deviceK253082 LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −3 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −2 | K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter… | Lin-Zhi International, Inc. | 2008 | 2 |
| −1 | K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls | Lin-Zhi International, Inc. | 2009 | — |
| 0 (this device) | K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and ControlsSummary page 6…prenorphine II Enzyme Immunoassay. The LZI Buprenorphine II Enzyme Immunoassay is similar to its legally marketed predicate device, LZI Buprenorphine Enzyme Immunoassay (k090844), in terms of intended use, method principle, device components, and clinical performance. Verification and validation activitie… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Buprenorphine II Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine at the cutoff value of 5 ng/mL when calibrated against norburprenorphine. 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…
Read the full statement (144 words)
The LZI Buprenorphine II Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of
norbuprenorphine in human urine at the cutoff value of 5 ng/mL when calibrated against norburprenorphine. 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 gas or liquid chromatography/mass spectrometry (GC/MS or
LC/MS) or (2) permitting laboratories to establish quality control procedures
The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid
chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253082: LZI Buprenorphine II Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253082
Report an extraction error
Are you the manufacturer?
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