# K063024: Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Oct 30, 2006 after 28 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: 3 generations back to K924446 (1992). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I, OraSure Technologies, Inc. (2000) Summary page 2.
- K050945: Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & Controls, Lin-Zhi International, Inc. (2006) Summary page 2.
- K050988: Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls, Lin-Zhi International, Inc. (2006) Summary page 2.
- K051058: Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls, Lin-Zhi International, Inc. (2006) Summary page 4.

## Most influential descendants
- K131653: Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls (2014), 0 descendants of its own

## Indications for use
The Amphetamine-Specific Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect amphetamine in human saliva with a cutoff of 45 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (d-amphetamine) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for amphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Oral Fluid Amphetamine-Specific Enzyme Immunoassay is a homogeneous enzyme immunoassay system 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 (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K063024
Methodology: https://510kreport.com/methodology