# K021449: Cannabinoid Urine Drugs of Abuse Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 18, 2002 after 43 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923386 (1992). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923386: THC Urine Calibrators, Diagnostic Reagents, Inc. (1992) Summary page 1.
- K932113: Cannabinoid Urine Controls, Diagnostic Reagents, Inc. (1993) Summary page 1.

## Most influential descendants
- K110239: Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control (2011), 4 descendants of its own
- K141320: LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls (2015), 2 descendants of its own
- K223162: Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT (2023), 1 descendant of its own
- K252523: Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test (2026), 0 descendants of its own
- K151203: Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set (2015), 0 descendants of its own

## Recalls of this device
- Feb 6, 2014 · Class II · Z-1178-2014: 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 shel

## Indications for use
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.

Source page: https://510kreport.com/device/K021449
Methodology: https://510kreport.com/methodology