# K040203: Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen Dipstick Test, Model MF22

- Pathway: 510(k) (Traditional)
- Applicant: Branan Medical Corp.
- Decided: Mar 25, 2004 after 56 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Monitect ® MDMA Drug Screen Cassette Test and the FastectTM II Drug Screen Dipstick Test are in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine above the cutoff concentration of 500 ng/mL. Both the Monitect® and FastectTM lI devices provide visual, qualitative results only. The devices are intended for in vitro diagnostic use in professional and laboratory settings only. The devices are not intended for over-the-counter sale to lay persons. The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. The Substance Abuse and Mental Health Services Administration (SAMHSA) has recognized Gas Chromatography/Mass Spectroscopy (GC/MS) as the preferred confirmatory method.

Source page: https://510kreport.com/device/K040203
Methodology: https://510kreport.com/methodology