# K043028: Emit II Plus Ecstasy Assay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 7, 2005 after 65 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.
6 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)
- K012110: Dri Ecstasy Enzyme Immunoassay, Microgenics Corp. (2001) Summary page 1.
- K012109: Dri Ecstasy Urine Calibrators, Microgenics Corp. (2001) Summary page 1.

## Most influential descendants
- 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
- K150275: Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls (2015), 0 descendants of its own
- K102045: Dimension Visa HBA1C, Model K3105A (2011), 0 descendants of its own

## Indications for use
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus Assays are designed for use with a number of chemistry analyzers. The Emit® II Plus Ecstasy Assay 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. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used. The Emit® II Plus Ecstasy Calibrators / Controls are used in the calibration of the Emit® II Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.

Source page: https://510kreport.com/device/K043028
Methodology: https://510kreport.com/methodology