510(k) · Cleared
ClearedDimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109
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 May 19, 2006 as substantially equivalent to K043028 (Dade Behring, Inc., 2005) after a 169-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- May 19, 2006
- Review
- 169 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010496 (2001). 5 ancestors in all, the oldest K983159 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010496 Cedia Dau Amphetamines/Ecstasy AssayMicrogenics Corp. · 2001
- 2 generations backK012110 Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp. · 2001
- 1 generation backK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
- This deviceK053337 Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK102045 Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010496 | Cedia Dau Amphetamines/Ecstasy Assay | Microgenics Corp. | 2001 | — |
| −2 | K012110 | Dri Ecstasy Enzyme Immunoassay | Microgenics Corp. | 2001 | — |
| −1 | K043028 | Emit II Plus Ecstasy Assay | Dade Behring, Inc. | 2005 | — |
| 0 (this device) | K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 | Dade Behring, Inc. | 2006 | — |
| +1 | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
| +2 | 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 | 1 | 0 |
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K043028 | Emit II Plus Ecstasy AssaySummary page 1…t cartridge / Amphetamine Test System Classification: Class II1(862.3100) 3. Identification of the Predicate Device Emnit® II Plus Ecstasy Assay, K043028 4. Device Description The Dimension® Urine Ecstasy Screen Flex® reagent cartridge is an in vitro diagnostic… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | 2006 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062128 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K043028.
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 EXTC Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The EXTC method provides…
Read the full statement (128 words)
The EXTC Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose.
The EXTC method 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. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053337 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053337: Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053337
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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