# K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Oct 28, 2002 after 84 days
- Product code: LAF (Gas 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
No predicates in its family tree.
94 later devices descend from it; 7 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FDA-cleared MDMA (Ecstasy) Test: named in the summary without a submission number

## Most influential descendants
- K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device (2003), 86 descendants of its own
- K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card (2003), 83 descendants of its own
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own

## Indications for use
The ACON MDMA One Step Ecstasy Test Strip and ACON MDMA One Step Ecstasy Test Device are rapid chromatographic immunoassays for the qualitative detection of Methylenedioxymethamphetamine (MDMA) in human urine at a designated cutoff concentration of 500 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites.

Source page: https://510kreport.com/device/K022589
Methodology: https://510kreport.com/methodology