510(k) · Cleared
ClearedCannabinoid Eia Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Reagents, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Nov 4, 1994 after a 136-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 4, 1994
- Review
- 136 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK943998 Cannabinoid Eia AssayDiagnostic Reagents, Inc. · 1994
- Descendant · cites it directly · 5 of its ownK021887 Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071Lin-Zhi International, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK110239 Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK141320 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid…Lin-Zhi International, Inc. · 2015
- Descendant · 4 generations on · 1 of its ownK223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC · 2023
- Descendant · 5 generations on · 0 of its ownK252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate…Healgen Scientific,, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K021887Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071Lin-Zhi International, Inc. · 2002 · cites it directly5descendants
- K110239Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, ControlLin-Zhi International, Inc. · 2011 · 2 generations on4descendants
- K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…Lin-Zhi International, Inc. · 2015 · 3 generations on2descendants
- K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC · 2023 · 4 generations on1descendant
- K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943998 | Cannabinoid Eia Assay | Diagnostic Reagents, Inc. | 1994 | — |
| +1 | K021887 | Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071 | Lin-Zhi International, Inc. | 2002 | — |
| +2 | K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control | Lin-Zhi International, Inc. | 2011 | — |
| +3 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids… | Lin-Zhi International, Inc. | 2015 | — |
| +4 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test… | Healgen Scientific,, LLC | 2023 | — |
| +5 | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid… | Healgen Scientific,, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
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?
- Of its descendants, K021887 (Lin-Zhi International, Inc., 2002) has gone furthest, with 5 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.
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 | — |
https://510kreport.com/device/K943998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943998: Cannabinoid Eia Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943998
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026