# K014101: Rapidone-Oxy Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Mar 20, 2002 after 97 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.
21 later devices descend from it; 3 cite it directly.
0 of 22 devices 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) RDS opiate test products: named in the summary without a submission number

## Most influential descendants
- K040411: Dri Oxycodone Assay (2004), 16 descendants of its own
- K060351: Medtox Oxycodone (2006), 6 descendants of its own
- K050733: Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls (2005), 6 descendants of its own
- K120763: Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls (2012), 5 descendants of its own
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), 4 descendants of its own

## Indications for use
‘RapidOne-OXY" Test is a one-step, lateral flow immunoassay for the detection of oxycodone in urine. ‘RapidOne-Oxy” Test is intended for the qualitative detection of oxycodone in human urine at 100 ng/ml. ‘RapidOne-OXY’ 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. This 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.) ‘RapidOune-OXY* Test provides only a preliminary analytical result. A more specific alternate 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/K014101
Methodology: https://510kreport.com/methodology