510(k) · Cleared
ClearedRapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icn Biomedicals, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Nov 22, 2002 after a 53-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 22, 2002
- Review
- 53 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Applied Biotech Sitrestep nuDrug Screen Test Methadone Named without a submission number |
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 DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, 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 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens, The presence of Methadone in human urine above a cutoff level of 300nglml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides…
Read the full statement (202 words)
Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens, The presence of Methadone in human urine above a cutoff level of 300nglml can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GUMS, must be used in order to obtain a confirmed analytical result.
Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml. can be detected.
The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons.
This test provides only a preliminary analytical test result. A more specific chemical method, such as GUMS, must be used in order to obtain a confirmed analytical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023252: Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023252
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026