# K060760: Rapidone-Buprenorphine Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Aug 7, 2006 after 139 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LC/MS results: named in the summary without a submission number

## Indications for use
'RapidOne'-Buprenorphine Test-is a one-step lateral flow immunoassay for the qualitative detection of 12.5 ng/mil of buprenorphine in human urine. 'RapidOne'-Buprenorphine 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. liquid chromatography/mass spectrometry (LC/MS). 'RapidOne'-Buprenorphine Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. LC/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/K060760
Methodology: https://510kreport.com/methodology