510(k) · Cleared
ClearedTHC Urine Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Reagents, Inc. · DLJ Calibrators, Drug Specific
Cleared on Sep 14, 1992 after a 75-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 14, 1992
- Review
- 75 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK923386 THC Urine CalibratorsDiagnostic Reagents, Inc. · 1992
- Descendant · cites it directly · 5 of its ownK021449 Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002 · Recalled
- 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 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K021449Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-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) | K923386 | THC Urine Calibrators | Diagnostic Reagents, Inc. | 1992 | — |
| +1 | K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | 1 |
| +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 |
|---|---|---|
| 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 DLJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and Controls | 2002 | 5 |
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, K021449 (Lin-Zhi International, Inc., 2002) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DLJ
Too few DLJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K923386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923386: THC Urine Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923386
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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