# K111363: PPX Reagent, PPX Calibrators, PPX QC Material

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Dec 6, 2011 after 204 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EasyRA PPX reagent is intended for the qualitative and semi-quantitative measurement of Propoxyphene (PPX) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. The cut-off point of the assay is 300ng/ml, and provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory method. The semi-quantitative mode is intended to enable laboratories to determine the appropriate dilution of the specimen for confirmation by a reference method such as GC/MS or LC/MS and to allow laboratories to establish effective quality control procedures for the PFX assay. Medica's Propoxyphene (PPX) Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent on the EasyRA clinical chemistry analyzer. Medica's Propoxylphene (PPX) CC Materials are intended for the validation of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent and PPX calibrator on the EasyRA clinical chemistry analyzer.

Source page: https://510kreport.com/device/K111363
Methodology: https://510kreport.com/methodology