510(k) · Cleared
ClearedRapid Drug Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bio Medica Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jul 25, 2001 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 25, 2001
- Review
- 33 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK012159 Rapid Drug ScreenAmerican Bio Medica Corp. · 2001
- Descendant · cites it directly · 1 of its ownK023869 'Rapidtec'-5M-Multiple Dip TestAmerican Bio Medica Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK073078 Rapid Tox CupAmerican Bio Medica Corp. · 2008
- Descendant · cites it directly · 0 of its ownK022388 Startox Drug of Abuse Screening Test (4)Starplex Scientific, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK021006 Startox Drug of Abuse Screening TestStarplex Scientific, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K023869'Rapidtec'-5M-Multiple Dip TestAmerican Bio Medica Corp. · 2003 · cites it directly1descendant
- K073078Rapid Tox CupAmerican Bio Medica Corp. · 2008 · 2 generations on0descendants
- K022388Startox Drug of Abuse Screening Test (4)Starplex Scientific, Inc. · 2003 · cites it directly0descendants
- K021006Startox Drug of Abuse Screening TestStarplex Scientific, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012159 | Rapid Drug Screen | American Bio Medica Corp. | 2001 | — |
| +1 | K023869 | 'Rapidtec'-5M-Multiple Dip Test | American Bio Medica Corp. | 2003 | — |
| +2 | K073078 | Rapid Tox Cup | American Bio Medica Corp. | 2008 | — |
| +1 | K022388 | Startox Drug of Abuse Screening Test (4) | Starplex Scientific, Inc. | 2003 | — |
| +1 | K021006 | Startox Drug of Abuse Screening Test | Starplex Scientific, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 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? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K023869 (American Bio Medica Corp., 2003) has gone furthest, with 1 descendant 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 ABM Rapid Drug Screen™ is for the determination of Cocaine, Opiates, Marijuana, PCP, Barbiturates, Benzodiazepines, Tricyclics, Methamphetamine and Amphetamines in human urine. The test is used to obtain visual, qualitative results and is intended for professional use only.
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/K012159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012159: Rapid Drug Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012159
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026