(66 days)
'Rapid One'-Propoxyphene Test is a one-step lateral flow immunoassay for the qualitative detection of 300 ng/ml of propoxyphene and norpropoxyphene in human urine.
'Rapid One'-Propoxyphene Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. This immunoassay is a simplified, qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas chromatography/mass spectrometry (GC/MS.)
'Rapid One'-Propoxyphene Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.
The assay employed in the 'Rapid One'-Propoxyphene Test is based on the same principle of highly specific reactions between antigens and antibodies.
This assay is a one-step, competitive, immunoassay for the detection of propoxyphene and its metabolite norpropoxyphene in human urine. The test device consists of a membrane strip onto which a drug conjugate has been immobilized and a colloidal goldmulti-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.
When drug is present in the urine sample, the drug or metabolite will compete with its corresponding drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.
A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions.
A negative urine will produce two colored bands, and a positive sample will produce only one band.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
Device Name: 'Rapid One'-Propoxyphene Test
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in terms of specific performance targets (e.g., sensitivity, specificity, accuracy percentages) that the device must meet. Instead, it describes the expected performance and successful reproducibility.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Detection of propoxyphene or norpropoxyphene at 300 ng/ml. | "‘Rapid One’-Propoxyphene Test will detect propoxyphene or norpropoxyphene at 300 ng/ml." |
| Reproducibility of results (above/below cut-off, negative). | "The results confirmed the reproducibility of the ‘Rapid One’-Propoxyphene Test performance." |
| Consistent control band presence for all reactions. | "The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present on all reactions." |
| Visual distinction between positive (one band) and negative (two bands) samples. | "A negative urine will produce two colored bands, and a positive sample will produce only one band." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states: "Each sample was tested four times, twice daily, for five days." It also mentions "control urines containing concentrations above and below the stated cut-off" and "Negative controls." However, the total number of distinct samples (e.g., individual patient urine samples) used for the reproducibility study is not specified.
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the testing was performed in a controlled laboratory setting. The data is prospective as it involves the preparation and testing of control urines for the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable, as the ground truth was established by analytical methods, not expert interpretation.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth (drug concentration) was objectively verified by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold-standard analytical method for drug confirmation. There was no mention of human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not conducted or described. This type of study is typical for imaging devices where human interpretation is a primary component. The 'Rapid One'-Propoxyphene Test is an in vitro diagnostic immunoassay with a direct visual output, not requiring human interpretation of complex images or data in the same way.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the described performance relates to the device itself performing the test and producing results. The statement "The results confirmed the reproducibility of the ‘Rapid One’-Propoxyphene Test performance" explicitly refers to the device's ability to provide consistent outputs. This is a standalone performance assessment in that it's the test kit's output without human influence on the result generation, though human observation is needed to visually read the bands.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the test samples (drug concentrations) was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and confirmatory analytical method for drug detection and quantification. The document states: "All concentrations were verified by GC/MS."
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an immunoassay kit, not a machine learning or AI-based algorithm that requires a separate "training set." The performance is inherent to the chemical and biological components of the test.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for this type of medical device.
§ 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).