510(k) · Cleared
ClearedCedia Dau Amphetamines/Ecstasy Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · LAF Gas Chromatography, Methamphetamine
Cleared on May 29, 2001 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 29, 2001
- Review
- 97 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK010496 Cedia Dau Amphetamines/Ecstasy AssayMicrogenics Corp. · 2001
- Descendant · cites it directly · 9 of its ownK012110 Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp. · 2001
- Descendant · 2 generations on · 6 of its ownK043028 Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK053337 Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK102779 Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy…Siemens Healthcare Diagnostics, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K012110Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp. · 2001 · cites it directly9descendants
- K043028Emit II Plus Ecstasy AssayDade Behring, Inc. · 2005 · 2 generations on6descendants
- K053337Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc. · 2006 · 3 generations on2descendants
- K102779Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level…Siemens Healthcare Diagnostics, Inc. · 2011 · 3 generations on1descendant
- K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010496 | Cedia Dau Amphetamines/Ecstasy Assay | Microgenics Corp. | 2001 | — |
| +1 | K012110 | Dri Ecstasy Enzyme Immunoassay | Microgenics Corp. | 2001 | — |
| +2 | K043028 | Emit II Plus Ecstasy Assay | Dade Behring, Inc. | 2005 | — |
| +3 | K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 | Dade Behring, Inc. | 2006 | — |
| +3 | K102779 | Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/… | Siemens Healthcare Diagnostics, Inc. | 2011 | 2 |
| +4 | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 3.7 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012110 | Dri Ecstasy Enzyme Immunoassay | 2001 | 9 |
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, K012110 (Microgenics Corp., 2001) has gone furthest, with 9 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 | — |
https://510kreport.com/device/K010496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010496: Cedia Dau Amphetamines/Ecstasy Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010496
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026