510(k) · Cleared
Cleared'Rapidone'-Methadone Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · DJR Enzyme Immunoassay, Methadone
Cleared on Nov 20, 2001 after a 132-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Nov 20, 2001
- Review
- 132 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not 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 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; 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 | K992325 | Forefront Diagnostics, Inc. ‘InstaCheck’ Drug Screen-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…equirements of 21 CFR 807.92. The assigned 510(k) number is: K012164 Predicate Device: Forefront Diagnostics, Inc. ‘InstaCheck’ Drug Screen-Methadone Test. (510(k) No. K992325) Test Description: The assay employed in the ‘RapidOne’-Methadone’ Test is based on the same principle of highly specific react… |
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?
‘RapidOne’-Methadone Test is a one-step, lateral flow immunoassay for the detection of methadone in urine. ‘RapidOne’-Methadone Test is intended for the qualitative detection of methadone in human urine at 300 ng/ml. ‘RapidOne’-Methadone Test is intended for professional use. It is not intended for over the counter sale to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified…
Read the full statement (143 words)
‘RapidOne’-Methadone Test is a one-step, lateral flow immunoassay for the detection of methadone in
urine.
‘RapidOne’-Methadone Test is intended for the qualitative detection of methadone in human urine at 300
ng/ml.
‘RapidOne’-Methadone Test is intended for professional use. It is not intended for over the counter sale to
nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. This
immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in
determining the need for additional or confirmatory testing, i.c., gas-chromatogfaphy/mass spectrometry
(GC/MS).
‘RapidOne’-Methadone Test provides only a preliminary analytical result. A more specific alternate
chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred
confirmatory method. Clinical and professional judgment should be applied to any drug of abuse
test result, particulary when preliminary results are used.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012164: 'Rapidone'-Methadone Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012164
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026