510(k) · Cleared
ClearedImmunalysis Amphetamine Elisa for Oral Fluids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunalysis Corporation · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 21, 2005 after a 129-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 21, 2005
- Review
- 129 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK051579 Immunalysis Amphetamine Elisa for Oral FluidsImmunalysis Corporation · 2005
- Descendant · cites it directly · 0 of its ownK101745 Thermo Scientific Cedia Amphetamine Oft AssayMicrogenics Corp. · 2011
Most influential descendants
Showing 1 of 1 · See all- K101745Thermo Scientific Cedia Amphetamine Oft AssayMicrogenics Corp. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051579 | Immunalysis Amphetamine Elisa for Oral Fluids | Immunalysis Corporation | 2005 | — |
| +1 | K101745 | Thermo Scientific Cedia Amphetamine Oft Assay | Microgenics Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101745 | Thermo Scientific Cedia Amphetamine Oft Assay | 2011 | 0 |
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, K101745 (Microgenics Corp., 2011) has gone furthest, with 0 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 Immunalysis Amphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Amphetamine in oral fluid samples collected with the Quantisal™ oral fluid collection device using a cutoff of 50 ng/mL of d-Amphetamine. This in-vitro diagnostic device is intended for clinical laboratory use only. The Immunalysis Amphetamine ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more…
Read the full statement (112 words)
The Immunalysis Amphetamine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Amphetamine in oral fluid samples collected with the Quantisal™ oral fluid collection device using a cutoff of 50 ng/mL of d-Amphetamine. This in-vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Amphetamine ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method. Clinical 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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051579: Immunalysis Amphetamine Elisa for Oral Fluids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051579
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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