# K013180: Rapidone-Ecstasy Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Nov 26, 2001 after 63 days
- Product code: DJC (Thin Layer Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010226 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010226: Verdict -II Methamphetamine, Medtox Diagnostics, Inc. (2001) Summary page 1.

## Indications for use
‘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.

Source page: https://510kreport.com/device/K013180
Methodology: https://510kreport.com/methodology