# K983700: Modification to Abuscreen Online for Propoxyphene

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Dec 11, 1998 after 51 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 K945195 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945195: Abuscreen Online Propoxphene, Roche Diagnostic Systems, Inc. (1994) Summary page 2.

## Most influential descendants
- K043303: Online Dat Propoxyphene Plus (2005), 0 descendants of its own

## Indications for use
Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative 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.

Source page: https://510kreport.com/device/K983700
Methodology: https://510kreport.com/methodology