510(k) · Cleared
ClearedRapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantrx Biomedical Corporation · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Feb 11, 2009 as substantially equivalent to K010841 (ACON Laboratories, Inc., 2001) after a 358-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Feb 11, 2009
- Review
- 358 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010841 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010841 Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test…ACON Laboratories, Inc. · 2001
- This deviceK080436 Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052Quantrx Biomedical Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010841 | Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device | ACON Laboratories, Inc. | 2001 | — |
| 0 (this device) | K080436 | Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052 | Quantrx Biomedical Corporation | 2009 | — |
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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.1 · 2 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 |
|---|---|---|---|
| * | K010841 | Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test DeviceSummary page 3…lways appear regardless of the presence of the drug if the assay has been performed properly. Predicate Device: ACON COC One Step Test Strip & Test Device 510(k) Number K010841 Comparison to Predicate Device Both the RapidSense T M Drugs of Abuse Cocaine (COC) 300 device and the ACON COC One Step Cocaine… | 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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K010841.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RapidSense Tm Drugs of Abuse Cocaine (COC) 300 Device is a lateral flow competitive immunoassay intended for the qualitative detection for the cocaine metabolite, benzoylecgoniine, in human urine at a cut-iff-snhcntraion.of 300 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For In Vitro Diagnostic Use. This assay provides only a preliminary result. Clinical consideration and professional judgment should…
Read the full statement (103 words)
The RapidSense Tm Drugs of Abuse Cocaine (COC) 300 Device is a lateral flow competitive immunoassay intended for the qualitative detection for the cocaine metabolite, benzoylecgoniine, in human urine at a cut-iff-snhcntraion.of 300 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/M4S) is the recommended confirmatory method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080436 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080436: Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080436
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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