# K020368: Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 4, 2002 after 120 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 K011150 (2001). 1 ancestor in all.
6 later devices descend from it; 3 cite 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)
- K011150: Dridau Opiate Assay, Microgenics Corp. (2001)

## Most influential descendants
- K120761: Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls (2012), 2 descendants of its own
- K141803: Immunalysis Tramadol Urine Enzyme Immunoassay (2015), 1 descendant of its own
- K110298: Opiate Enzyme Immunoassay (2011), 1 descendant of its own
- K203527: Immunalysis Tapentadol Urine HEIA (2022), 0 descendants of its own
- K172416: Synermed Opiate Enzyme Immunoassay (2018), 0 descendants of its own

## Indications for use
The Opiate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/dL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of opiates in human urine. The Opiate 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 (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K020368
Methodology: https://510kreport.com/methodology