# K033743: Cozart Eia Amphetamines Oral Fluid Microplate Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cozart Bioscience, Ltd.
- Decided: Jun 3, 2004 after 188 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: 2 generations back to K933052 (1993). 2 ancestors in all.
2 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)
- K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I, OraSure Technologies, Inc. (2000) Summary page 1.

## Most influential descendants
- K130811: Psychemedics Microplate Eia for Amphetamine (2013), 1 descendant of its own
- K210212: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (2021), 0 descendants of its own

## Indications for use
The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is intended for use in clinical and forensic laboratories when used in conjunction with the Cozart® RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for amphetamines in human oral fluid at a cutoff concentration of 15ng/ml. This is equal to 45ng/ml in neat oral fluid as the collection system involves a 1:3 dilution of the sample. This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GCMS) is the preferred confirmatory method.

Source page: https://510kreport.com/device/K033743
Methodology: https://510kreport.com/methodology