# K012164: 'Rapidone'-Methadone Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Nov 20, 2001 after 132 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K992325: Forefront Diagnostics, Inc. ‘InstaCheck’ Drug Screen-Methadone Test. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
‘RapidOne’-Methadone Test is a one-step, lateral flow immunoassay for the detection of methadone in urine. ‘RapidOne’-Methadone Test is intended for the qualitative detection of methadone in human urine at 300 ng/ml. ‘RapidOne’-Methadone Test is intended for professional use. It is not intended for over the counter sale 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.c., gas-chromatogfaphy/mass spectrometry (GC/MS). ‘RapidOne’-Methadone 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, particulary when preliminary results are used.

Source page: https://510kreport.com/device/K012164
Methodology: https://510kreport.com/methodology