510(k) · Cleared
ClearedQuickscreen One Step Cocaine Screening Test (9070)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phamatech · DMN Thin Layer Chromatography, Cocaine
Cleared on Aug 8, 1997 after a 28-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 8, 1997
- Review
- 28 days
- Class
- Class II
- Product code
- DMN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DMN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | ABI SureStep Named without a submission number | |
| * | — | Syntron Bioresearch Cocaine Test Named without a submission number |
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.
How does its category compare?
All DMN devicesDMN Thin Layer Chromatography, Cocaine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DMN
FDA has decided no DMN device since 2007.
Median 510(k) review, days · DMN
Too few DMN 510(k)s in any year since 2007 to give a median.
Recalls per year · DMN
No recall names DMN since 2007.
Adverse event reports per year · DMN
No MAUDE report names DMN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians’ offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative or quantitative identification of cocaine and cocaine metabolite (benzoylecgonine), in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
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/K972618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972618: Quickscreen One Step Cocaine Screening Test (9070).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972618
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026