# K043303: Online Dat Propoxyphene Plus

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 11, 2005 after 101 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: 2 generations back to K945195 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983700: Modification to Abuscreen Online for Propoxyphene, Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Indications for use
Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on Roche/Hitachi automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of propoxyphene use or abuse and do not measure a level of toxicity. Propoxyphene Plus 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/K043303
Methodology: https://510kreport.com/methodology