(139 days)
'RapidOne'-Buprenorphine Test is a one-step lateral flow immunoassay for the qualitative detection of 12.5 ng/ml of buprenorphine in human urine.
'RapidOne'-Buprenorphine 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. liquid chromatography/mass spectrometry (LC/MS).
'RapidOne'-Buprenorphine Test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a more confirmed result. LC/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"-Buprenorphine 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 buprenorphine-and buprenorphine glucuronide 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 gold-antibody 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 compage. An absence of a color band (Ime) in the "test" grea is indicative of a possive result.
A control band (line), comprised of a different autibody/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 will produce two colored bands, and a positive sample will produce only one band.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that supports the device's performance:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated in Intent) | Reported Device Performance |
|---|---|
| Detection of buprenorphine at 12.5 ng/ml | "RapidOne'-Buprenorphine Test will detect buprenorphine at 12.5 ng/ml" |
| Detection of buprenorphine glucuronide at 10.0 ng/ml | "RapidOne'-Buprenorphine Test will detect buprenorphine glucuronide at 10.0 ng/ml" |
| Reproducibility for concentrations above and below cutoff | "The results confirmed the reproducibility of the 'RapidOne'-Buprenorphine Test performance." |
| Substantial equivalence to LC/MS | "'RapidOne' - Buprenor phine Test is substantially equivalent to the results obtained with LC/MS." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days."
- Sample Size for Test Set: The exact number of distinct urine samples used for the test set is not explicitly stated. However, it specifies that "Each sample was tested four times, twice daily, for five days," which means each distinct sample generated 40 individual test results (4 tests/day * 5 days * 2 sessions/day, but the text literally says "tested four times, twice daily, for five days", so it seems like 4 tests were done each day, twice a day, for 5 days. Or it means 4 tests in total, each done twice daily for 5 days to get reproducibility. The phrasing is a bit ambiguous. Assuming the simpler reading where "Each sample was tested four times" refers to 4 distinct test runs per sample over the 5 days, and then "twice daily" refers to the frequency of these test runs.). Given the ambiguity, we can't definitively state the total number of samples.
- Data Provenance: The document does not specify the country of origin of the data. It mentions "control urines," suggesting laboratory-prepared or validated samples rather than necessarily patient-derived, but this is not explicitly stated. It is a prospective study, as the device performance was being actively evaluated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
The ground truth for the test set was established using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate analytical method. The document does not describe a human adjudication method in the traditional sense (e.g., 2+1, 3+1), as the ground truth was determined by an objective analytical instrument.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, and the performance evaluation focuses on its analytical accuracy and reproducibility against a gold standard analytical method (LC/MS and GC/MS), not on human reader interpretation.
6. Standalone Performance Study
Yes, a standalone (algorithm only, without human-in-the-loop performance) study was done. The "Performance Characteristics" section describes the device's ability to detect buprenorphine and buprenorphine glucuronide at specific concentrations and its reproducibility, all assessed directly by the device itself against validated "control urines" whose concentrations were confirmed by GC/MS and LC/MS.
7. Type of Ground Truth Used
The primary ground truth used for both detection limits and reproducibility was analytical confirmation by GC/MS and LC/MS. These are objective, laboratory-based analytical methods considered gold standards for drug detection and quantification.
8. Sample Size for the Training Set
The document does not mention a "training set" or a machine learning/AI component for this device. The RapidOne-Buprenorphine Test is described as an immunoassay based on the specific reactions between antigens and antibodies, implying a biochemical test, not one that requires a training set for model development.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).