510(k) · Cleared
ClearedCozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cozart Bioscience, Ltd. · DJG Enzyme Immunoassay, Opiates
Cleared on Nov 5, 2002 after a 229-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below).
- Decided
- Nov 5, 2002
- Review
- 229 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below).
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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K971961 | RapidOne Opiates Test Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…shment RegistrationNo.: 3002336046 Performance Standards: BS EN IS0 9001 :1994, EN 46001 : 1996 Substantial Equivalence: RapidOne Opiates Test, 5 1O(k) no. k97 1961 RapidOne Methadone Test, 5 10(k) no. k992325 Introduction The Cozart RapiScan Oral Fluid D… | |
| Kept off the family tree | K992325 | RapidOne Methadone Test Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…9001 :1994, EN 46001 : 1996 Substantial Equivalence: RapidOne Opiates Test, 5 1O(k) no. k97 1961 RapidOne Methadone Test, 5 10(k) no. k992325 Introduction The Cozart RapiScan Oral Fluid Drug Test System for Opiates and Methadone is a point of care test (POCT) fo… |
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 DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The Cozart RapiScan Oral Fluid Drug Test System - Opiates and Methadone is intended for Point of Care testing in a number of settings such as prescription workplace, drug dependency clinics. and criminal justice. It provides qualitative screening results for opiates and methadone in human oral fluid at a cut-off concentration equivalent to 40nglmL and 30nglmL respectively in neat oral fluid. The cozart collection system involves a 1.3 dilution of the…
Read the full statement (242 words)
The Cozart RapiScan Oral Fluid Drug Test System - Opiates and Methadone is intended for
Point of Care testing in a number of settings such as prescription workplace, drug dependency
clinics. and criminal justice. It provides qualitative screening results for opiates and methadone
in human oral fluid at a cut-off concentration equivalent to 40nglmL and 30nglmL respectively
in neat oral fluid. The cozart collection system involves a 1.3 dilution of the oral fluid sample,
this dilution factor is corrected for in the Cozart RapiScan Drug Test and therefore the
remainder of this document will refer to the cut-offs as 13ng/mL for opiates and IOng/ml for
methadone.
This kit has to be used in conjunction with the Cozart RapiScan instrument. Please refer to the
sampling and testing procedures in the instructions for use leaflet.
This assay i s for professional use only and provides only a preliminary analytical test
result. Clinical consideration and professional judgement must be applied t o 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.
It is the responsibility of those organisations required to follow department of transportation (DOT) or the Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing guidelines to determine that this product satisfies the criteria for workplace testing established under DOT and SAMHSA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020920: Cozart Rapiscan Oral Fluid Drug Test - Opiate/Methadone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020920
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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