# K020869: First Check Home Drug Test for Mdma (Ecstasy)

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Corp.
- Decided: Jun 11, 2002 after 85 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Phamatech At Home Drug Test: named in the summary without a submission number
- (no number) First Check Home Drug Tests using a single or multi-drug display: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K011133: Applied Biotech SureStep MDMA (Ecstasy) Drug Screen 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

## Indications for use
The First Check@ Home Drug Test for MDMA (Ecstasy) is a screening test for the rapid detection of MDMA and its metabolites in human urine at a cut-off level of 500 ng/ml. The test is,intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of MDMA or its metabolites in a urine sample. Such information is beneficial to consumer efforts to comply with applicable laws andor societal expectations.

Source page: https://510kreport.com/device/K020869
Methodology: https://510kreport.com/methodology