510(k) · Cleared
ClearedRapidone-Ecstasy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Nov 26, 2001 as substantially equivalent to K010226 (Medtox Diagnostics, Inc., 2001) after a 63-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 26, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- DJC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010226 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010226 Verdict -II MethamphetamineMedtox Diagnostics, Inc. · 2001
- This deviceK013180 Rapidone-Ecstasy TestAmerican Bio Medica Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010226 | Verdict -II Methamphetamine | Medtox Diagnostics, Inc. | 2001 | — |
| 0 (this device) | K013180 | Rapidone-Ecstasy Test | American Bio Medica Corp. | 2001 | — |
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 DJC? 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 DJC device
- #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K010226 | Verdict -II MethamphetamineSummary page 1…h the requirements of 21 CFR 807.92. The assigned 510(k) number is: _H (3180 Predicate Device: MedTox Diagnostics, Inc., Verdict II-Methamphetamine Test. (510(k) No. K-010226). Test Description: The assay employed in the ‘RapidOne’-Ecstasy’ Test is based on the same principle of highly specific reacti… | 2001 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJC
258in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJC
No recall names DJC since 2007.
Adverse event reports per year · DJC
2in 2018
MAUDE reports naming product code DJC, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 3 | 258 | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
‘RapidOne-Ecstasy’ Test is a one-step, lateral flow immunoassay for the detection of 3,4-methylenedioxymethamphetamine (MDMA, ‘Ecstasy’) at 1000 ng/ml in urine. ‘RapidOne-Ecstasy’-Test is intended for the qualitative detection of MDMA in human urine. ‘RapidOne-Ecstasy” Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision.…
Read the full statement (143 words)
‘RapidOne-Ecstasy’ Test is a one-step, lateral flow immunoassay for the detection of 3,4-methylenedioxymethamphetamine (MDMA, ‘Ecstasy’) at 1000 ng/ml in urine.
‘RapidOne-Ecstasy’-Test is intended for the qualitative detection of MDMA in human urine.
‘RapidOne-Ecstasy” Test is intended for professional use. It is not intended for over-the-counter sales 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.e., gas chromatography/mass spectrometry (GC/MS).
‘RapidOne-Ecstasy’ 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, particularly 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/K013180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013180: Rapidone-Ecstasy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013180
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026