The Propoxyphene Test System is designed to measure the concentration of propoxyphene, a prescription pain medication, in biological samples such as serum or plasma. This test system helps in monitoring propoxyphene levels for therapeutic purposes and detecting potential overdose or misuse.

Intended Use of Propoxyphene Test System

A Propoxyphene Test System is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

Intended Use

The Test system is an immunochromatographic assay for detecting d-Propoxyphene in urine at a cutoff of 300 ng/mL. Available in dip card and test cup formats, it provides preliminary results only. Confirmatory testing with methods like GC/MS is required for definitive results. The test may show positive results even at therapeutic doses and cannot distinguish between prescription use and abuse. Clinical judgment should be applied when interpreting results.

Device Description

This device is a rapid immunoassay for detecting d-Propoxyphene in urine. The test uses a monoclonal antibody-dye conjugate and drug-protein conjugates on a membrane. When a urine sample is applied, it mixes with the conjugate, and if the drug concentration is below the cutoff, a colored line appears in the Test Region (T), indicating a negative result. If above the cutoff, no line forms in the Test Region (T), suggesting a potentially positive result. A line in the Control Region (C) confirms the test is valid.

• • Accuracy
  • Precision (Reproducibility and Repeatability)
  • Sensitivity and Specificity
  • Cross-Reactivity
  • Stability
  • Lay-user study
  • Comparison study

  Clinical Testing

  No Guidance available  for 510k submission