# K110298: Opiate Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jul 15, 2011 after 164 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: 2 generations back to K011150 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020368: Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit), Lin-Zhi International, Inc. (2002) Summary page 2.

## Most influential descendants
- K172416: Synermed Opiate Enzyme Immunoassay (2018), 0 descendants of its own

## Indications for use
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine, at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. 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 (GC/MS 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/K110298
Methodology: https://510kreport.com/methodology