510(k) · Cleared
ClearedCozart Eia Cocaine Oral Fliud Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cozart Bioscience, Ltd. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Apr 28, 2003 as substantially equivalent to K981341 (OraSure Technologies, Inc., 1998) after a 95-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Apr 28, 2003
- Review
- 95 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924446 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981341 | STC Opiates Micro-Plate Eia (Orasure Application)Summary page 1…3002336046 Performance Standards BS EN IS0 9001:1994; EN 46001:1996 Substantial Equivalence STC Opiates Micro-Plate EIA (Orasure@Application), 5 1O(k) no. K98 1341 Cozart EIA Cocaine Oral Fluid Kit Parameter Intended Use Target Population Clinical and… | 1998 |
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.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K981341.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cozart EIA Cocaine 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 cocaine and metabolites in human oral fluid at a cutoff concentration of 10nglml. This is equal to 30ng/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. This assay…
Read the full statement (134 words)
The Cozart EIA Cocaine 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 cocaine and metabolites in human oral fluid at a cutoff concentration of 10nglml. This is equal to 30ng/mL in undiluted 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 ChromatographyIMass Spectrometry (GCIMS) is the preferred confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030234: Cozart Eia Cocaine Oral Fliud Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030234
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026