510(k) · Cleared
ClearedSyva Emit II Plus Amphetamines 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 Jun 6, 2003 as substantially equivalent to K993982 (Syva Co., 2000) after a 67-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jun 6, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993982 (2000). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993982 Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129ULSyva Co. · 2000
- This deviceK031004 Syva Emit II Plus Amphetamines AssayDade Behring, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK040133 Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDade Behring, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK062077 Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS…Ortho-Clinical Diagnostics, Inc. · 2006 · 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 ownK143500 Immunalysis Amphetamine 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
Most influential descendants
Showing 5 of 5 · See all- K040133Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDade Behring, Inc. · 2004 · cites it directly2descendants
- K062077Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly1descendant
- K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · 2 generations on1descendant
- K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…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 |
|---|---|---|---|---|---|
| −1 | K993982 | Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL | Syva Co. | 2000 | — |
| 0 (this device) | K031004 | Syva Emit II Plus Amphetamines Assay | Dade Behring, Inc. | 2003 | — |
| +1 | K040133 | Urine Amphetamine/Methamphetamine Screen Flex Reagent Cartridge | Dade Behring, Inc. | 2004 | — |
| +1 | K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1… | Ortho-Clinical Diagnostics, Inc. | 2006 | 5 |
| +2 | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
| +2 | K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine… | Immunalysis Corporation | 2015 | — |
| +3 | K102045 | Dimension Visa HBA1C, Model K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 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? (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 |
|---|---|---|---|
| * | K993982 | Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129ULSummary page 1…Class I1 III. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE SyvaB Emit@ I1 Plus Monoclonal AmphetarninehlethamphetamineAssay (K993982). IV. DEVICE DESCRIPTION The Emit@I1 Plus Amphetamines Assay is a homogeneous enzyme immunoassay for the qualitativ… | 2000 |
| † | K912024 | Automated Biochemical Analyzer (WAK0-20R & 30R) | 1991 |
What descends from it? (5)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K040133 (Dade Behring, Inc., 2004) has gone furthest, with 2 descendants of its own.
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 Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff, 500 ng/mL cutoff or a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit II Plus assays are designed for use with a number of chemistry analyzers. The Emit II Plus Amphetamines Assay provides only a preliminary analytical test result. A more…
Read the full statement (123 words)
The Emit II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff, 500 ng/mL cutoff or a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit II Plus assays are designed for use with a number of chemistry analyzers.
The Emit II Plus Amphetamines 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 (GCMS) 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/K031004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031004: Syva Emit II Plus Amphetamines Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031004
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