510(k) · Cleared
ClearedPsychemedics Microplate Eia for Amphetamine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Psychemedics Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on May 2, 2013 as substantially equivalent to K033743 (Cozart Bioscience, Ltd., 2004) after a 38-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- May 2, 2013
- Review
- 38 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933052 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK933052 Abuscreen Online (R) for Amphetamines, ModifiedRoche Diagnostic Systems, Inc. · 1993
- 2 generations backK992918 STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103IOraSure Technologies, Inc. · 2000
- 1 generation backK033743 Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd. · 2004
- This deviceK130811 Psychemedics Microplate Eia for AmphetaminePsychemedics Corp. · 2013
- Descendant · cites it directly · 0 of its ownK210212 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933052 | Abuscreen Online (R) for Amphetamines, Modified | Roche Diagnostic Systems, Inc. | 1993 | — |
| −2 | K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I | OraSure Technologies, Inc. | 2000 | — |
| −1 | K033743 | Cozart Eia Amphetamines Oral Fluid Microplate Kit | Cozart Bioscience, Ltd. | 2004 | — |
| 0 (this device) | K130811 | Psychemedics Microplate Eia for Amphetamine | Psychemedics Corp. | 2013 | — |
| +1 | K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K033743 | Cozart Eia Amphetamines Oral Fluid Microplate KitSummary page 1…ice Trade Name: Psychemedics Microplate ETA for Amphetamine in Hair Predicate Device: Cozart ETA Amphetamine Oral Fluid Microplate Kit, k033743 Product Code: DKZ Device Classification/Name: 21 CFR 862.3 100, Enzyme Immunoassay. Amphetamine;… | 2004 |
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 |
|---|---|---|---|
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | 2021 | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K210212 (Psychemedics Corporation, 2021) 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. 2013, 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 Psychemnedics Microplate ETA for Amphetamine is an enzyme immunoassay (ELA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identify'ing amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories. The…
Read the full statement (151 words)
The Psychemnedics Microplate ETA for Amphetamine is an enzyme immunoassay (ELA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identify'ing amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories.
The Psychemedics Microplate ETA amphetamine assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry ((iC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Psychemnedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different sites.
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/K130811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130811: Psychemedics Microplate Eia for Amphetamine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130811
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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