# K080436: Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052

- Pathway: 510(k) (Traditional)
- Applicant: Quantrx Biomedical Corporation
- Decided: Feb 11, 2009 after 358 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010841 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010841: Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device, ACON Laboratories, Inc. (2001) Summary page 3.

## Indications for use
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.

Source page: https://510kreport.com/device/K080436
Methodology: https://510kreport.com/methodology