# K113661: Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jan 23, 2012 after 41 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934891 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102210: Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls, Lin-Zhi International, Inc. (2010) Summary page 4.

## Most influential descendants
- K201442: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers (2020), 0 descendants of its own

## Indications for use
The LZI Methamphetamine Enzyme Immunoassay is intended for the qualitative and semniquantitative determination of d-methamphetamine in human urine, at the cutoff value of 500 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 Methamphetamine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methamphetamine Enzyme Immunoassay at a cutoff value of 500 ng/nt. The LZI Methamphetamine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Methamphetamine Enzyme Immunoassay at a cutoff value of 500 ng/nmh. The assay provides only a preliminary analytical result. A more specific alternatfive 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/K113661
Methodology: https://510kreport.com/methodology