# K033094: Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Dec 19, 2003 after 81 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
Longest line of descent: 2 generations back to K010496 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012110: Dri Ecstasy Enzyme Immunoassay, Microgenics Corp. (2001) Summary page 1.
- K012109: Dri Ecstasy Urine Calibrators, Microgenics Corp. (2001) Summary page 5.

## Indications for use
The Ecstasy Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Ecstasy enzyme immunoassay to detect ecstasy drugs in human urine. The Ecstasy Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Ecstasy enzyme immunoassay to detect ecstasy drugs in human urine. The Ecstasy Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 500 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of Ecstasy (MDMA) in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Ecstasy Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K033094
Methodology: https://510kreport.com/methodology