510(k) · Cleared
ClearedLzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Jun 23, 2011 as substantially equivalent to K021887 (Lin-Zhi International, Inc., 2002) and 1 other predicate after a 148-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it.
- Decided
- Jun 23, 2011
- Review
- 148 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923386 (1992). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923386 THC Urine CalibratorsDiagnostic Reagents, Inc. · 1992
- 1 generation backK021449 Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002 · Recalled
- This deviceK110239 Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK141320 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid…Lin-Zhi International, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate…Healgen Scientific,, LLC · 2026
- Descendant · cites it directly · 0 of its ownK151203 Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC…Immunalysis Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…Lin-Zhi International, Inc. · 2015 · cites it directly2descendants
- K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC · 2023 · 2 generations on1descendant
- K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 3 generations on0descendants
- K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…Immunalysis Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923386 | THC Urine Calibrators | Diagnostic Reagents, Inc. | 1992 | — |
| −1 | K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | 1 |
| 0 (this device) | K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control | Lin-Zhi International, Inc. | 2011 | — |
| +1 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids… | Lin-Zhi International, Inc. | 2015 | — |
| +2 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test… | Healgen Scientific,, LLC | 2023 | — |
| +3 | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid… | Healgen Scientific,, LLC | 2026 | — |
| +1 | K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine… | Immunalysis Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2023 | 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K021887 | Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071Summary page 2…munoassays (EIAs) are substantially equivalent to the Lin-Zhi International, Inc. Cannabinoid (THC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (k021887 & k021449) manufactured by Lin-Zhi International, Inc. The LZI Cannabinoids (¢cTHC) 25, 50, and 100 Enzyme Immunoassays are ident… | 2002 |
| * | K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and ControlsSummary page 2…(EIAs) are substantially equivalent to the Lin-Zhi International, Inc. Cannabinoid (THC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (k021887 & k021449) manufactured by Lin-Zhi International, Inc. The LZI Cannabinoids (¢cTHC) 25, 50, and 100 Enzyme Immunoassays are identical or si… | 2002 |
What descends from it? (4)
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 19 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K141320 (Lin-Zhi International, Inc., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LZI Cannabinoids (cTHC) Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Cannabinoids in human urine using 11-nor-LUo-THC- 9-COOH (the major metabolite of THC referred to here as cTHC) as calibrator at the cutoff values of 25, 50, or 100 ng/mL. The assay is designed for prescription use with a number of automalted clinical chemistry analyzers. The semi-quantitative mode is for the purposes of (1) enabling…
Read the full statement (210 words)
The LZI Cannabinoids (cTHC) Enzyme Immunoassay is intended for the qualitative and
semi-quantitative determination of Cannabinoids in human urine using 11-nor-LUo-THC-
9-COOH (the major metabolite of THC referred to here as cTHC) as calibrator at the
cutoff values of 25, 50, or 100 ng/mL. The assay is designed for prescription use with a
number of automalted clinical chemistry analyzers.
The semi-quantitative mode is for the purposes of (1) enabling laboratories to determine
an appropriate dilution of the specimen for confirmation by a confirmatory method such
as GC/MS or (2) permitting laboratories to establish quality control procedures.
The Cannabinoids (cTHC) Drugs of Abuse (DAU) Calibrators are for use as calibrators
in the qualitative and semi-quantitative calibration of the LZI Cannabinoids (cTHC)
Enzyme Immunoassay.
The Cannabinoids (cTHC) Drugs of Abuse (DAU) Controls are for use as assayed quality
control materials to monitor the precision of the LZI Cannabinoids (cTHC) 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. Gas or
liquid chromatography/mass spectrometry (GCIMS 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110239: Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110239
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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