# K021887: Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Aug 15, 2002 after 69 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: 1 generation back to K943998 (1994). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943998: Cannabinoid Eia Assay, Diagnostic Reagents, Inc. (1994) 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

## Indications for use
The Cannabinoid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SHAHSA recommended initial test cutoff concentration), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of cannabinoids (THC) in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Cannabinoid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgement should be -of-abuse test result, particularly when preliminary positive results are

Source page: https://510kreport.com/device/K021887
Methodology: https://510kreport.com/methodology