510(k) · Cleared
ClearedRapid Drug Screen 5-Panel with Methamphetamine Test
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 Feb 26, 1999 as substantially equivalent to K964900 (American Bio Medica Corp., 1997) after a 67-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Feb 26, 1999
- Review
- 67 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964900 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964900 Rapid Drug ScreenAmerican Bio Medica Corp. · 1997
- This deviceK984525 Rapid Drug Screen 5-Panel with Methamphetamine TestAmerican Bio Medica Corp. · 1999
- Descendant · cites it directly · 0 of its ownK993961 Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC)…American Bio Medica Corp. · 2000
- Descendant · cites it directly · 0 of its ownK993796 Rapid Drug Screen 5-Panel Drug Screening Test for Cocaine…American Bio Medica Corp. · 1999
Most influential descendants
Showing 2 of 2 · See all- K993961Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates…American Bio Medica Corp. · 2000 · cites it directly0descendants
- K993796Rapid Drug Screen 5-Panel Drug Screening Test for Cocaine, Marijuana, Opiates…American Bio Medica Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964900 | Rapid Drug Screen | American Bio Medica Corp. | 1997 | — |
| 0 (this device) | K984525 | Rapid Drug Screen 5-Panel with Methamphetamine Test | American Bio Medica Corp. | 1999 | — |
| +1 | K993961 | Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and… | American Bio Medica Corp. | 2000 | — |
| +1 | K993796 | Rapid Drug Screen 5-Panel Drug Screening Test for Cocaine, Marijuana, Opiates… | American Bio Medica Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K964900 | Rapid Drug ScreenSummary page 1…ance with the requirements of 21 CFR 807.92. The assigned 510(k) is: Predjcate Devices; American Bio Medica “Rapid Drug Screen” 5-Panel test kit with PCP (510(k) No. K-964900). All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specific reaction between… | 1997 |
| † | K972556 | Quickscreen One Step Methamphetamine Test (9065) | 1997 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K993961 (American Bio Medica Corp., 2000) 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?
“Rapid Drug Screen” with methamphetamine is a one-step, lateral flow immunoassay for the simulatenous detection in urine of five abused drugs at stated detectable limits. (Each assay occupies a seperate channel). It is intended for use in the qualitative detection of d-Amphetamine (750 ng/ml), Benzoy! ecgonine (225 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (225 ng/ml). “Rapid Drug Screen” is intended for use by…
Read the full statement (165 words)
“Rapid Drug Screen” with methamphetamine is a one-step, lateral flow immunoassay for the simulatenous detection in urine of five abused drugs at stated detectable limits. (Each assay occupies a seperate channel). It is intended for use in the qualitative detection of d-Amphetamine (750 ng/ml), Benzoy! ecgonine (225 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (225 ng/ml).
“Rapid Drug Screen” is intended for use by professional laboratories. The assays are easy to perform, but should not be used without proper supervision. These immuno-assay is a simplified qualatative screening method that provides only a preliminary result for use in the need for aditional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).
“Rapid Drug” screen provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgement showld be applied to any drug of abuse test result, partlculary when preliminary positive-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/K984525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984525: Rapid Drug Screen 5-Panel with Methamphetamine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984525
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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