510(k) · Cleared
ClearedEmit II Plus Ecstasy Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jan 7, 2005 as substantially equivalent to K012110 (Microgenics Corp., 2001) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 2001. 6 later devices descend from it.
- Decided
- Jan 7, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010496 (2001). 4 ancestors in all, the oldest K983159 (1998). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK010496 Cedia Dau Amphetamines/Ecstasy AssayMicrogenics Corp. · 2001
- 1 generation backK012110 Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp. · 2001
- This deviceK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK053337 Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK102779 Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy…Siemens Healthcare Diagnostics, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK150275 Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015
- Descendant · 3 generations on · 0 of its ownK102045 Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K053337Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006 · cites it directly2descendants
- K102779Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level…Siemens Healthcare Diagnostics, Inc. · 2011 · cites it directly1descendant
- K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · 2 generations on1descendant
- K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine…Immunalysis Corporation · 2015 · 2 generations on0descendants
- K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010496 | Cedia Dau Amphetamines/Ecstasy Assay | Microgenics Corp. | 2001 | — |
| −1 | K012110 | Dri Ecstasy Enzyme Immunoassay | Microgenics Corp. | 2001 | — |
| 0 (this device) | K043028 | Emit II Plus Ecstasy Assay | Dade Behring, Inc. | 2005 | — |
| +1 | K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 | Dade Behring, Inc. | 2006 | — |
| +1 | K102779 | Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/… | Siemens Healthcare Diagnostics, Inc. | 2011 | 2 |
| +2 | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
| +2 | K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis… | Immunalysis Corporation | 2015 | — |
| +3 | K102045 | Dimension Visa HBA1C, Model K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012110 | Dri Ecstasy Enzyme ImmunoassaySummary page 1…linical Toxicology Control Classification: Class 1(862.3280) 3. Identification of the Legally Marketed Device DRI® Ecstasy Enzyme Immunoassay, K01211 0 DRI® Ecstasy Urine Calibrators, K012109 Emit® Calibrator/Control, K993755. Dade Behring Inc. 51… | 2001 |
| * | K012109 | Dri Ecstasy Urine CalibratorsSummary page 1…: Class 1(862.3280) 3. Identification of the Legally Marketed Device DRI® Ecstasy Enzyme Immunoassay, K01211 0 DRI® Ecstasy Urine Calibrators, K012109 Emit® Calibrator/Control, K993755. Dade Behring Inc. 510(k) Notification - Emit® IIPlus Ecstasy Assay an… | 2001 |
| † | K993755 | Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5 | 1999 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K053337 (Dade Behring, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K012110.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (156 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043028: Emit II Plus Ecstasy Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043028
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026