510(k) · Cleared
ClearedImmunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
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 Feb 6, 2015 as substantially equivalent to K062077 (Ortho-Clinical Diagnostics, Inc., 2006) after a 58-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Feb 6, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993982 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK993982 Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129ULSyva Co. · 2000
- 2 generations backK031004 Syva Emit II Plus Amphetamines AssayDade Behring, Inc. · 2003
- 1 generation backK062077 Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- This deviceK143500 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993982 | Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL | Syva Co. | 2000 | — |
| −2 | K031004 | Syva Emit II Plus Amphetamines Assay | Dade Behring, Inc. | 2003 | — |
| −1 | K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1… | Ortho-Clinical Diagnostics, Inc. | 2006 | 5 |
| 0 (this device) | K143500 | Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine… | Immunalysis Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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 |
|---|---|---|---|
| * | K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Summary page 5…Verifiers I, II, III, IV and V 2. Predicate Company: Ortho-Clinical Diagnostics, Inc 3. Predicate K Number: K062077 D. Device Description The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/… | 2006 |
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?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semi- quantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro device is for prescription use only. The semi-quantitative mode is for purposes of…
Read the full statement (216 words)
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual
cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-
quantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is
calibrated against Amphetamine. This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen
for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control
procedures.
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit 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 (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred
confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result,
particularly when preliminary positive results are used.
Immunalysis Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Controls are used as control materials
in Immunalysis Amphetamine Urine Enzyme Immunoassay.
Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators are used as calibrators in
the Immunalysis Amphetamine Urine Enzyme Immunoassay. for the qualitative and semi-quantitative determination of
Amphetamine in urine on automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143500: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143500
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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