510(k) · Cleared
ClearedSyva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · LAF Gas Chromatography, Methamphetamine
Cleared on Jan 27, 2000 after a 64-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jan 27, 2000
- Review
- 64 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK993982 Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129ULSyva Co. · 2000
- Descendant · cites it directly · 5 of its ownK031004 Syva Emit II Plus Amphetamines AssayDade Behring, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK040133 Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDade Behring, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK062077 Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK143500 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031004Syva Emit II Plus Amphetamines AssayDade Behring, Inc. · 2003 · cites it directly5descendants
- K040133Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDade Behring, Inc. · 2004 · 2 generations on2descendants
- K062077Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics, Inc. · 2006 · 2 generations on1descendant
- K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · 3 generations on1descendant
- K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…Immunalysis Corporation · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K040133 | Urine Amphetamine/Methamphetamine Screen Flex Reagent Cartridge | Dade Behring, Inc. | 2004 | — |
| +2 | K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1… | Ortho-Clinical Diagnostics, Inc. | 2006 | 5 |
| +3 | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
| +3 | K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine… | Immunalysis Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 LAF? 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 LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 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 |
|---|---|---|---|
| * | — | Syva Emit® II Monoclonal Amphetamine/Methamphetamine Assay Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031004 | Syva Emit II Plus Amphetamines Assay | 2003 | 5 |
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?
- Of its descendants, K031004 (Dade Behring, Inc., 2003) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with 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 Monoclonal Amphetamine/Methamphetamine Assay provides only a preliminary…
Read the full statement (118 words)
The Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with 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 Monoclonal Amphetamine/Methamphetamine 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993982 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993982: Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993982
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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