(189 days)
'RapidOne'-Cocaine-150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoyl ecgonine in human urine. 'RapidOne'-Cocaine-150 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. The 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). 'RapidOne'-Cocaine-150 Test provides only a preliminary analytical result. A more specific alternative 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 'RapidOne-Cocaine-150 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 benzoyl ecgonine in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and a colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal goldantibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. 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 the 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. 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 of 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.
The 'RapidOne'-Cocaine-150 Test is a qualitative immunoassay for detecting benzoyl ecgonine in human urine. The study presented a limited set of performance data primarily focused on reproducibility, as the device was deemed "substantially equivalent" to a previously cleared device. Due to the nature of the submission (510(k) for substantial equivalence and the limited information provided in the summary), a full, detailed study report with all the requested information is not present. The information below is extracted from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Detection Limit | Not explicitly stated as a separate criterion; implied to be 150 ng/ml for benzoyl ecgonine. | 'RapidOne'-Cocaine-150 Test will detect benzoyl ecgonine at 150 ng/ml. |
| Reproducibility | Consistent and accurate results across multiple tests, across concentrations above/below cutoff. | Confirmed by testing control urines (above/below cutoff and negative) four times daily for five days. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The study mentions "control urines containing concentrations above and below the stated cut-off" and "Negative controls were also used." It also states "Each sample was tested four times, twice daily, for five days," which implies repeat testing of a smaller set of samples rather than a large test set for overall performance.
- Data Provenance: Not specified. The summary does not provide details about the origin of the urine samples (e.g., country of origin, retrospective or prospective collection).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable/not stated.
- Qualifications of Experts: Not applicable/not stated. Ground truth for performance was established using GC/MS.
4. Adjudication Method
- Adjudication Method: Not applicable. Human experts were not involved in establishing the ground truth for this performance study; GC/MS was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a standalone in-vitro diagnostic test.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the described performance relates to the standalone performance of the device without human-in-the-loop assistance beyond the usual interpretation of a qualitative test result (presence/absence of a line). The study focuses on the device's ability to detect the analyte at a specified concentration.
7. Type of Ground Truth Used
- Ground Truth Type: Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "All concentrations were verified by GC/MS." and "GC/MS is the preferred confirmatory method."
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable/not stated. This type of immunoassay device does not typically involve a "training set" in the context of machine learning algorithms. Its design and cutoff are based on established biochemical principles and often validated against known concentrations.
9. How Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. As mentioned above, a training set is not relevant for this immunoassay's development. The cutoff and performance characteristics are based on the immunoassay's design and validated using reference methods like GC/MS.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).