510(k) · Cleared
ClearedEmit II Plus Cocaine Metabolite Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Jul 23, 2003 as substantially equivalent to K993988 (Syva Co., 2000) after a 70-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Jul 23, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993988 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993988 Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULSyva Co. · 2000
- This deviceK031512 Emit II Plus Cocaine Metabolite AssayDade Behring, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK033713 Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92ADade Behring, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK102045 Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK062123 Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K033713Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92ADade Behring, Inc. · 2004 · cites it directly2descendants
- K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · 2 generations on1descendant
- K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · 3 generations on0descendants
- K062123Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029UL | Syva Co. | 2000 | — |
| 0 (this device) | K031512 | Emit II Plus Cocaine Metabolite Assay | Dade Behring, Inc. | 2003 | — |
| +1 | K033713 | Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92A | Dade Behring, Inc. | 2004 | — |
| +2 | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
| +3 | K102045 | Dimension Visa HBA1C, Model K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011 | 3 |
| +1 | K062123 | Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and… | Ortho-Clinical Diagnostics, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 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 |
|---|---|---|---|
| * | K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULSummary page 1…Product Code: 91 DIO 3. Identification of the Legally Marketed Device: EmitmI1 Plus Cocaine Metabolite Assay (K993988) 4. Device Description: Ernit@II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for… | 2000 |
What descends from it? (4)
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?
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Emit II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit II Plus assays are designed for use with a number of chemistry analyzers. The Emit II Plus Monoclonal Cocaine Metabolite Assay provides only a preliminary analytical…
Read the full statement (123 words)
The Emit II Plus Cocaine Metabolite Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff (SAMSHA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine. Emit II Plus assays are designed for use with a number of chemistry analyzers.
The Emit II Plus Monoclonal Cocaine Metabolite 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 as stated in the FDA summary.
https://510kreport.com/device/K031512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031512: Emit II Plus Cocaine Metabolite Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031512
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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