# K012110: Dri Ecstasy Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Aug 27, 2001 after 52 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: 1 generation back to K010496 (2001). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010496: Cedia Dau Amphetamines/Ecstasy Assay, Microgenics Corp. (2001) Summary page 1.

## Most influential descendants
- K043028: Emit II Plus Ecstasy Assay (2005), 6 descendants of its own
- K053337: Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 (2006), 2 descendants of its own
- K102779: Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-AM / Ectasy C (2011), 1 descendant of its own
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays (2006), 1 descendant of its own
- K240670: DRI Ecstasy Plus Assay (2024), 0 descendants of its own

## Indications for use
The DRI Ecstasy Enzyme Immunoassay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a Cutoff level of 500 ng/mL. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order 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/K012110
Methodology: https://510kreport.com/methodology