# K053422: Rapidone-Cocaine-150 Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Jun 15, 2006 after 189 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 K990822 (1999). 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)
- K990822: Rapidone - Cocaine Test, American Bio Medica Corp. (1999) Summary page 1.

## Indications for use
'RapidOne'-Cocaine-150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoyl ecgonine in human urine. 'RapidOne'-Cocaine-150 Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. The immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC[MS). 'RapidOne'-Cocaine-150 Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.

Source page: https://510kreport.com/device/K053422
Methodology: https://510kreport.com/methodology