510(k) · Cleared
ClearedRapidtox
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 May 25, 2006 after a 174-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 25, 2006
- Review
- 174 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK053359 RapidtoxAmerican Bio Medica Corp. · 2006
- Descendant · cites it directly · 0 of its ownK073078 Rapid Tox CupAmerican Bio Medica Corp. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073078Rapid Tox CupAmerican Bio Medica Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053359 | Rapidtox | American Bio Medica Corp. | 2006 | — |
| +1 | K073078 | Rapid Tox Cup | American Bio Medica Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073078 | Rapid Tox Cup | 2008 | 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, K073078 (American Bio Medica Corp., 2008) 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 RapidTox TM is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette). Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels: Compound — Test Abbreviation — Level (ng/ml) Amphetamine (d-amphetamine sulfate) — AMP — 1000 Barbiturates (secobarbital)…
Read the full statement (216 words)
The RapidTox TM is a one-step, lateral flow immunoassay for the simultaneous detection of up to ten abused drug analytes in urine (each analyte is represented by a line in the test window of the cassette).
Rapid Tox is intended for use in the qualitative detection of the following drugs of abuse in human urine at the following levels:
Compound — Test Abbreviation — Level (ng/ml)
Amphetamine (d-amphetamine sulfate) — AMP — 1000
Barbiturates (secobarbital) — BAR — 300
Benzodiazepine (oxazepam) — BZO — 300
Cocaine (benzoylecgonine) — COC — 300
MDMA ((+/-)3,4-methylenedioxy-methamphetamine) (Ecstasy) — MDMA — 1000
Methadone — MTD — 300
Methamphetamine ((+/-)methamphetamine HCI) — MET — 1000
Opiates (morphine-3-b-D-glucuronide) — OPt — 300
2000
Oxycodone — OXY — IOO
Phencyclidine (phencyclidine HC1) — PCP — 25*
Propoxyphene/Norpropoxyphene — PPX — 300
THC/Cannabinoids (I 1-nor-A9-THC-9-carboxylic-acid) — THC — 50'
Tricyclic Antidepressants (nortriptyline) — TCA — 1000
Rapid Tox provides only a preliminary analytic test result. More specific alternative chemical methods must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The Test is recommended for professional use. It is not intended for over-the-counter sales to nonprofessionals.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053359 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053359: Rapidtox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053359
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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