510(k) · Cleared
ClearedStartox Drug of Abuse Screening Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starplex Scientific, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jun 10, 2002 as substantially equivalent to K002447 (American Bio Medica Corp., 2000) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 10, 2002
- Review
- 74 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002447 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK002447 Modification to Rapid Drug Screen 9-PanelAmerican Bio Medica Corp. · 2000
- This deviceK021006 Startox Drug of Abuse Screening TestStarplex Scientific, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002447 | Modification to Rapid Drug Screen 9-Panel | American Bio Medica Corp. | 2000 | — |
| 0 (this device) | K021006 | Startox Drug of Abuse Screening Test | Starplex Scientific, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K002447 | Modification to Rapid Drug Screen 9-PanelSummary page 2…human urine at the levels indicated STARTOXTMis substantial equivalent to Rapid Drug Screen 9 panel manufactured by American BioMedica Corporation 5 10k number K002447. Product performance was compared Medtox Profile I1 manufactured by Medtox Diagnostics. Ninety (90) samples were tested… | 2000 |
| * | K012159 | Rapid Drug Screen | 2001 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K002447.
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?
STARTOXTM Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOXTM is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: Compound — Abbreviation — Level Amphetamine (d-amphetamine sulfate) — AMP — 1000 ng/ml Opiates (morphine-3-P-D glucuronide) —…
Read the full statement (147 words)
STARTOXTM Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. STARTOXTM is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
Compound — Abbreviation — Level
Amphetamine (d-amphetamine sulfate) — AMP — 1000 ng/ml
Opiates (morphine-3-P-D glucuronide) — OPIATES — 2000 ng/ml
Phencyclidine (phencyclidine HCI) — PCP — 25 ng/ml
Cocaine (benzoylecgonine) — COCAINE — 300 ng/ml
Cannabinoids (1 l-nor-A9-THC-9-carboxylic-acid) — THC — 50 ng/ml
STARTOXTM Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GUMS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021006: Startox Drug of Abuse Screening Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021006
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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