(52 days)
VERDICT® II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE 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 OBTAINED.
VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (VERDICT®-II PROPOXYPHENE ) |
|---|---|
| Rapid, qualitative detection of propoxyphene and its metabolite (norpropoxyphene) in human urine. | The device provides rapid, qualitative detection of propoxyphene and norpropoxyphene in human urine. |
| Detection of norpropoxyphene at 300 ng/mL. | The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The adjudication method is not mentioned in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size of human reader improvement with AI assistance, is provided in the document. This is an in vitro diagnostic device, and such studies are typically not performed for this type of product.
6. Standalone Performance (Algorithm Only)
The device, VERDICT®-II PROPOXYPHENE, is described as a "one-step immunochromatographic test." This indicates it's a physical test kit, not an algorithm, and therefore the concept of standalone (algorithm-only) performance does not apply. The document does state that the test provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result" (e.g., GC/MS). This implies the device's performance is as a screening tool, not a definitive standalone diagnostic.
7. Type of Ground Truth Used
The document explicitly states that the device provides "only a preliminary analytical test result" and that "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." This indicates that the ground truth for validating the device's performance would be established by a "gold standard" confirmatory method like GC/MS.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document focuses on the device's indications for use and substantial equivalence to a predicate device. It does not detail the specific methodology for establishing ground truth for any training set. However, given the nature of the device (a rapid screening test for drug detection) and the mention of GC/MS as a confirmatory method, it's highly probable that samples with known concentrations of propoxyphene and norpropoxyphene (likely confirmed by methods like GC/MS) would be used to develop and validate such a test.
§ 862.3700 Propoxyphene test system.
(a)
Identification. 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.(b)
Classification. Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).