510(k) · Cleared

Cleared

Cozart Eia Opiates Oral Fluid Kit

K024339510(k) TraditionalCleared Apr 7, 2003101-day reviewClass I21 CFR 862.3240

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cozart Bioscience, Ltd. · DIG Cholinesterase Test Paper

Cleared on Apr 7, 2003 after a 101-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Apr 7, 2003
Review: 101 days
Class: Class I
Product code: DIG
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K024339Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DIG devices

DIG Cholinesterase Test Paper: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIG

FDA has decided no DIG device since 2007.

Median 510(k) review, days · DIG

Too few DIG 510(k)s in any year since 2007 to give a median.

Recalls per year · DIG

No recall names DIG since 2007.

Adverse event reports per year · DIG

No MAUDE report names DIG since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Cozart EIA Opiates Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for Opiates in human oral fluid at a cutoff concentration of IOnglml. This is equal to 3Ong/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. This assay is for…

Read the full statement (132 words)

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 ChromatographylMass Spectrometry (GCIMS) is the preferred confirmatory method.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K024339 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024339: Cozart Eia Opiates Oral Fluid Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024339

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026