510(k) · Cleared
ClearedLZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
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 May 28, 2015 as substantially equivalent to K110239 (Lin-Zhi International, Inc., 2011) after a 373-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- May 28, 2015
- Review
- 373 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923386 (1992). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK923386 THC Urine CalibratorsDiagnostic Reagents, Inc. · 1992
- 2 generations backK021449 Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002 · Recalled
- 1 generation backK110239 Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2011
- This deviceK141320 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid…Lin-Zhi International, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate…Healgen Scientific,, LLC · 2026
Most influential descendants
Showing 2 of 2 · See all- K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC · 2023 · cites it directly1descendant
- K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923386 | THC Urine Calibrators | Diagnostic Reagents, Inc. | 1992 | — |
| −2 | K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | 1 |
| −1 | K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control | Lin-Zhi International, Inc. | 2011 | — |
| 0 (this device) | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids… | Lin-Zhi International, Inc. | 2015 | — |
| +1 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test… | Healgen Scientific,, LLC | 2023 | — |
| +2 | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid… | Healgen Scientific,, LLC | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, ControlSummary page 5…noassay (k141320) is substantially equivalent to the Lin-Zhi International, Inc. Cannabinoid (cTHC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (k110239) manufactured by Lin-Zhi International, Inc. The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is identical or similar to its pr… | 2011 |
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 |
|---|---|---|---|
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | 2023 | 1 |
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 23 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K223162 (Healgen Scientific,, LLC, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K110239.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Oral Fluid Cannabinoids Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Cannabinoids in neat human oral fluid, collected into the LZI Oral Fluid THC Collector, at the cut-off value of 4 ng/mL with Δ9- tetrahydrocannabinol (THC) as calibrators. 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…
Read the full statement (222 words)
The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Cannabinoids in neat human oral fluid, collected into the LZI Oral Fluid THC Collector, at the cut-off value of 4 ng/mL with Δ9- tetrahydrocannabinol (THC) as calibrators. 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 GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.
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 (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.
The LZI Oral Fluid Cannabinoids Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL.
The LZI Oral Fluid Cannabinoids Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141320: LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141320
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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