# K141055: Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 13, 2014 after 50 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: 4 generations back to K014101 (2002). 4 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K120763: Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls, Lin-Zhi International, Inc. (2012) Summary page 2.

## Most influential descendants
- K150502: DRI Hydrocodone Assay, DRI Hydrocodone Calibrators,  DRI Hydrocodone Controls (2015), 2 descendants of its own
- K231752: ARK Hydrocodone Assay (2023), 0 descendants of its own
- K173195: DRI Hydrocodone Assay (2018), 0 descendants of its own

## Indications for use
The LZI Hydrocodone Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of hydrocodone in human urine at the cutoff values of 100 and 300 ng/mL when calibrated against hydrocodone. The assay is designed for prescription 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 Hydrocodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi- quantitative calibration of the LZI Hydrocodone Enzyme Immunoassay at the cutoff value of 100 and 300 ng/mL. The LZI Hydrocodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Hydrocodone Enzyme Immunioassay at the cutoff value of 100 and 300 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 LCIMS) 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/K141055
Methodology: https://510kreport.com/methodology