510(k) · Cleared
ClearedEcstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Dec 19, 2003 as substantially equivalent to K012110 (Microgenics Corp., 2001) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Dec 19, 2003
- Review
- 81 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). No later device cites it as a predicate yet.
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) | K033094 | Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161… | Lin-Zhi International, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 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…Lin-Zhi International, Inc.' Ecstasy Enzyme Immunoassay is substantially equivalent to the DPI Ecstasy Assay (By Microgenics Corp.), cleared under premarket notification K01 21 10. LZI's Ecstasy Enzyme Immunoas say is identical or similar to its predicate in terms of intended use, method principle, device c… | 2001 |
| * | K012109 | Dri Ecstasy Urine CalibratorsSummary page 5…librators and Controls are substantially equivalent to the DRI Ecstasy Urine Calibrators and controls, by Microgenics Corporation, cleared under premarket notifications (K012 109). Page 3 Device D… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- 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 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…
Read the full statement (158 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033094: Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033094
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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