510(k) · Cleared
ClearedUrine Amphetamine/Methamphetamine Screen Flex Reagent Cartridge
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 Apr 8, 2004 as substantially equivalent to K031004 (Dade Behring, Inc., 2003) after a 78-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 8, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993982 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK993982 Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129ULSyva Co. · 2000
- 1 generation backK031004 Syva Emit II Plus Amphetamines AssayDade Behring, Inc. · 2003
- This deviceK040133 Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDade Behring, Inc. · 2004
- 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 |
|---|---|---|---|---|---|
| −2 | K993982 | Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL | Syva Co. | 2000 | — |
| −1 | K031004 | Syva Emit II Plus Amphetamines Assay | Dade Behring, Inc. | 2003 | — |
| 0 (this device) | K040133 | Urine Amphetamine/Methamphetamine Screen Flex Reagent Cartridge | Dade Behring, Inc. | 2004 | — |
| +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 |
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 |
|---|---|---|---|
| * | K031004 | Syva Emit II Plus Amphetamines AssaySummary page 2…nical chemistry system. F. Substantial Equivalence Inforamtion: 1. Predicate Device: Syva® Emit® II Plus Amphetamine Assay 2. Predicate K Number(s): K031004 3. Comparision with Predicate: This product is substantially equivalent to other Amphetamine… | 2003 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062128 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031004.
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 AMPH Flexc reagent cartridge used on the Dimension 0 clinical chemistry system provides reagents for an in viiro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500 or 10OOng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The AMPIH method provides only a preliminary analytical test…
Read the full statement (124 words)
The AMPH Flexc reagent cartridge used on the Dimension 0 clinical chemistry system provides reagents for an in viiro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500 or 10OOng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.
The AMPIH 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/K040133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040133: Urine Amphetamine/Methamphetamine Screen Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040133
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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