510(k) · Cleared
Recalled · Class II · 2014Cannabinoid Urine Drugs of Abuse Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DLJ Calibrators, Drug Specific
Cleared on Jun 18, 2002 as substantially equivalent to K923386 (Diagnostic Reagents, Inc., 1992) and 1 other predicate after a 43-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 18, 2002
- Review
- 43 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923386 (1992). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK923386 THC Urine CalibratorsDiagnostic Reagents, Inc. · 1992
- This deviceK021449 Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK110239 Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators…Lin-Zhi International, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK141320 LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid…Lin-Zhi International, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK223162 Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid…Healgen Scientific,, LLC · 2023
- Descendant · 4 generations on · 0 of its ownK252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate…Healgen Scientific,, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK151203 Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC…Immunalysis Corporation · 2015
Most influential descendants
Showing 5 of 5 · See all- K110239Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, ControlLin-Zhi International, Inc. · 2011 · cites it directly4descendants
- K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…Lin-Zhi International, Inc. · 2015 · 2 generations on2descendants
- K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC · 2023 · 3 generations on1descendant
- K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC · 2026 · 4 generations on0descendants
- K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…Immunalysis Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923386 | THC Urine Calibrators | Diagnostic Reagents, Inc. | 1992 | — |
| 0 (this device) | K021449 | Cannabinoid Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | — |
| +1 | K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control | Lin-Zhi International, Inc. | 2011 | — |
| +2 | K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids… | Lin-Zhi International, Inc. | 2015 | — |
| +3 | K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test… | Healgen Scientific,, LLC | 2023 | — |
| +4 | K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid… | Healgen Scientific,, LLC | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K923386 | THC Urine CalibratorsSummary page 1…lly equivalent to the A°-Cannabinoid (THC) Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications K923386 and 932113. 10 u -- Device Description AI1 of the Cannabinoid ine DAU Calibrators am Contro… | 1992 |
| * | K932113 | Cannabinoid Urine ControlsSummary page 1…nt to the A°-Cannabinoid (THC) Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications K923386 and 932113. 10 u -- Device Description AI1 of the Cannabinoid ine DAU Calibrators am Controls are huma… | 1993 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110239 | Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control | 2011 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2014 | Class II | Z-1178-2014 | Nonconforming Material/Component | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K110239 (Lin-Zhi International, Inc., 2011) has gone furthest, with 4 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 | — |
What is it indicated for?
The Cannabinoid Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.
The Cannabinoid Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.
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/K021449 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021449: Cannabinoid Urine Drugs of Abuse Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021449
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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