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The Instant-View™ Propoxyphene (PPX) Urine Test is a rapid one-step immunoassay intended for use in the qualitative detection of propoxyphene in human urine at a cutoff concentration of 300 ng/ml. It is for health care professional use only.

This test 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.

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The provided text is an FDA 510(k) clearance letter for the Instant-View™ Propoxyphene (PPX) Urine Test. It does not contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria. The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Details about experts, adjudication methods, or ground truth establishment.
• Information on MRMC studies or standalone algorithm performance.

The document states the "Indications For Use" and mentions a cutoff concentration of 300 ng/ml for qualitative detection of propoxyphene in human urine, but it does not elaborate on the specific performance metrics or studies used to validate this.

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