# K020395: Amphetamines Enzyme Immunoassay, Catalog #0040 (500 Tests Kit), Catalog #0041 (5000 Tests Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 4, 2002 after 118 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 K934891 (1994). 1 ancestor in all.
3 later devices descend 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)
- K934891: Amphetamines Eia Assay Modification, Diagnostic Reagents, Inc. (1994) Summary page 1.

## Most influential descendants
- K102210: Lzi Amphetamines 500 Homogenous Enzyme Immunoassay; Lzi Amphetamines 500 Calibrators; Lzi Amphetamines 500 Controls (2010), 2 descendants of its own
- K113661: Lzi Methamphetamine Enzyme Mmunoassay, Lzi Methamphetamine Calibrators, Lzi Methamphetamine Controls (2012), 1 descendant of its own
- K201442: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers (2020), 0 descendants of its own

## Indications for use
The Amphetamines Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. The Amphetamines 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/K020395
Methodology: https://510kreport.com/methodology