# K030835: 'Rapid One' - Propoxyphene Test

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: May 22, 2003 after 66 days
- Product code: JXN (Enzyme Immunoassay, Propoxyphene)
- Device class: 2
- Regulation: 21 CFR 862.3700
- 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
- K002141: Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit, Exactech, Inc. (2000). Our reading of the summary gave K002141, FDA’s number for Acumatch P-Series Press-Fit Plasma, Acumatch P-Series… (Exactech, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MedTox Diagnostics, Inc. 2-Panel Propoxyphene/MAMP-MDMA Test”. Kept off the family tree. Summary page 1.

## Indications for use
‘Rapid One’-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine. ‘Rapid One’-Propoxyphene 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 (GCMS.) ‘Rapid One’-Propoxyphene Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GCMS 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/K030835
Methodology: https://510kreport.com/methodology