510(k) · Cleared
ClearedStartox Drug of Abuse Screening Test (4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starplex Scientific, Inc. · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Feb 27, 2003 as substantially equivalent to K012159 (American Bio Medica Corp., 2001) and 1 other predicate after a 219-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 27, 2003
- Review
- 219 days
- Class
- Class II
- Product code
- DJC
- 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 deviceK022388 Startox Drug of Abuse Screening Test (4)Starplex Scientific, Inc. · 2003
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) | K022388 | Startox Drug of Abuse Screening Test (4) | Starplex Scientific, Inc. | 2003 | — |
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 DJC? 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 DJC device
- #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K012159 | Rapid Drug Screen | 2001 |
| * | K002447 | Modification to Rapid Drug Screen 9-PanelSummary page 2…rugs in 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 for Opiates, Cocaine and Cannabinoids was compared Medtox Profile 11 manufactured by Medtox Diagnostics. Pe… | 2000 |
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 K012159.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJC
258in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJC
No recall names DJC since 2007.
Adverse event reports per year · DJC
2in 2018
MAUDE reports naming product code DJC, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 3 | 258 | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
“STARTOX” Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. “STARTOX” 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 Methamphetamine ((+/-)methamphetamine HCI) — METH — 1000 ng/ml Opiates (morphine) — OPIATES —…
Read the full statement (140 words)
“STARTOX” Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. “STARTOX” 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
Methamphetamine ((+/-)methamphetamine HCI) — METH — 1000 ng/ml
Opiates (morphine) — OPIATES — 300 ng/ml
Cocaine (benzoylecgonine) — COCAINE — 300 ng/ml
Cannabinoids (1l-nor-A9-THC-9-carboxylic-acid) — THC — 50 ng/ml
STARTOXTMDrugs 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 (GCMS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
For professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022388: Startox Drug of Abuse Screening Test (4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022388
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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