# K110239: Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 23, 2011 after 148 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923386 (1992). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021887: Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071, Lin-Zhi International, Inc. (2002) Summary page 2.
- K021449: Cannabinoid Urine Drugs of Abuse Calibrators and Controls, Lin-Zhi International, Inc. (2002) Summary page 2.

## Most influential descendants
- 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

## Indications for use
The LZI Cannabinoids (cTHC) Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Cannabinoids in human urine using 11-nor-LUo-THC- 9-COOH (the major metabolite of THC referred to here as cTHC) as calibrator at the cutoff values of 25, 50, or 100 ng/mL. The assay is designed for prescription use with a number of automalted clinical chemistry analyzers. The semi-quantitative mode is for the purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS or (2) permitting laboratories to establish quality control procedures. The Cannabinoids (cTHC) Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Cannabinoids (cTHC) Enzyme Immunoassay. The Cannabinoids (cTHC) Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Cannabinoids (cTHC) Enzyme Immunoassay. 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 (GCIMS 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

Source page: https://510kreport.com/device/K110239
Methodology: https://510kreport.com/methodology