# K120761: Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: May 8, 2012 after 56 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 K983159 (1998). 4 ancestors in all.
2 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)
- K020368: Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit), Lin-Zhi International, Inc. (2002). Our reading of the summary gave K020638, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Opiate Enzyme Immunoassay”.
- K020769: Single Analyte Urine Drugs of Abuse Calibrators and Controls, Lin-Zhi International, Inc. (2002) Summary page 2.

## Most influential descendants
- K141803: Immunalysis Tramadol Urine Enzyme Immunoassay (2015), 1 descendant of its own
- K203527: Immunalysis Tapentadol Urine HEIA (2022), 0 descendants of its own

## Indications for use
The LZI Opiate 2000 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of morphine in human urine at the cutoff value of 2000 ng/mL. 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 and LCMS or (2) permitting laboratories to establish quality control procedures. The LZI Opiate 2000 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL. The LZI Opiate 2000 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Opiate 2000 Enzyme Immunoassay at a cutoff value of 2000 ng/mL. 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/K120761
Methodology: https://510kreport.com/methodology