# K013100: Propoxyphene

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 20, 2002 after 184 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
Longest line of descent: 1 generation back to K923873 (1992). 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)
- K923873: Syva Emit II Propoxyphene Assay, Syva Co. (1992) Summary page 2.

## Indications for use
The Propoxyphene assay is used for the qualitative analysis of propoxyphene in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis or treatment of propoxyphene use or overdose. The Propoxyphene assay is calibrated with propoxyphene and will detect propoxyphene and metabolites and analogs. The Propoxyphene assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K013100
Methodology: https://510kreport.com/methodology