510(k) · Cleared
ClearedCedia Dau Amphassure Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on May 2, 2000 as substantially equivalent to K883707 (Abbott Laboratories, 1988) after a 127-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- May 2, 2000
- Review
- 127 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883707 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK883707 TDX Amphetamine/Methamphetamine IIAbbott Laboratories · 1988
- This deviceK994380 Cedia Dau Amphassure AssayMicrogenics Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883707 | TDX Amphetamine/Methamphetamine II | Abbott Laboratories | 1988 | — |
| 0 (this device) | K994380 | Cedia Dau Amphassure Assay | Microgenics Corp. | 2000 | — |
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 |
|---|---|---|---|
| * | K883707 | TDX Amphetamine/Methamphetamine IISummary page 1…n of amphetamines in urine. Classification name: Amphetamine test system We claim substantial equivalence to the TDx/TDxFLx Amphetamine/Methamphetamine II Immunoassay (K883707) manufactured by Abbott Laboratories Inc. Continued on next page Microgenics Corporation CEDIA® DAU AmphAssure Assay page 23… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
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.
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 CEDIA® DAU AmphAssure Assay is a homogeneous enzyme immunoassay for the in vitro qualitative determination of amphetamines in human urine on automated clinical chemistry analyzers. This device is used as an accessory to immunoassay screening tests to reduce the number of false positive results needing confirmation testing. Measurements are used as an aid in the diagnosis and treatment of amphetamine use or overdose. The assay provides only a…
Read the full statement (122 words)
The CEDIA® DAU AmphAssure Assay is a homogeneous enzyme immunoassay for the in vitro
qualitative determination of amphetamines in human urine on automated clinical chemistry
analyzers. This device is used as an accessory to immunoassay screening tests to reduce the
number of false positive results needing confirmation testing. Measurements are used as an aid
in the diagnosis and treatment of amphetamine use or overdose.
The assay provides only a preliminary analytical result. A more specific alternative chemical
method must be used to obtain a confirmed analytical result. GCMS is the preferred
confirmatory method. Other chemical confirmation methods are available. Clinical
consideration and professional judgement should be applied to any drug of abuse test result
particularly when preliminary positive test 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/K994380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994380: Cedia Dau Amphassure Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994380
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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