(234 days)
'RapidOne' - Benzodiazepine Test is a one-step, lateral flow immunoassay for the detection of Benzodiazepine in urine. 'RapidOne' - Benzodiazepine Test is intended for use in the qualitative detection of : oxazepam { in human urine at 300 ng/m}.
'RapidOne' - Benzodiazepine Test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy 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).
'RapidOne' - Benzodiazepine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The assay employed in the 'RapidOne' - Benzodiazepine Test is based on the same principle of highly specific reaction between antigens and antibodies.
This assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which anti-amphetamine monoclonal antibody has been immobilized. A colloidal gold-BSAamphetamine complex is dried on a reagent pad. In the absence of any drug in the urine sample, the colloidal gold-complex moves with the urine by capillary action to contact the immobilized drug antibody. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the test area occurs when the test is negative.
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-antibody complex. If sufficient amount of drug is present, it will fill all of the available 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 of absence of drug in the urine, and therefore, should be present in all reactions.
A negative urine will produce two colored bands, and a positive sample will produce only one band.
This document describes the acceptance criteria and the study conducted for the 'RapidOne' - Benzodiazepine Test, a qualitative immunoassay for detecting oxazepam in human urine.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance observed in comparison to a predicate device and established cut-offs.
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Qualitative Detection of Oxazepam at 300 ng/ml Cut-off | Correctly identified all 40 drug-containing specimens (concentrations 310 ng/ml to 10000 ng/ml) as positive. |
| Agreement with Predicate Device (Instacheck) for Negative Samples | All 50 drug-free samples were correctly identified as negative by the 'RapidOne' test (and also by the predicate device). |
| Agreement with Predicate Device (Instacheck) for Positive Samples | All 40 drug-containing samples (confirmed positive by Syva EMIT-II and GC/MS) were correctly identified as positive by the 'RapidOne' test (and also by the predicate device). |
| Reproducibility - Negative Urine (0 ng/ml) | 40/40 negative results (reported as >99% precision for negative samples). |
| Reproducibility - Below Cut-off (225 ng/ml) | 32/40 negative results (reported as >80% precision for negative results at this concentration). This indicates that at concentrations below the cut-off, the device predominantly yields negative results, as expected. |
| Reproducibility - At Cut-off (300 ng/ml) | 40/40 positive results (reported as >99% precision for positive samples at the cut-off). This demonstrates reliable detection at the specified cut-off. |
| Reproducibility - Above Cut-off (375 ng/ml) | 40/40 positive results (reported as >99% precision for positive samples at this concentration). This demonstrates reliable detection above the specified cut-off. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Comparative Study with Predicate: 90 samples
- 50 drug-free samples
- 40 drug-containing samples
- Sample Size for Reproducibility Study:
- For each concentration (0, 225, 300, 375 ng/ml): 40 tests were performed (4 times daily, twice daily, for 5 days).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that existing samples (some confirmed by Syva EMIT-II and GC/MS) were used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It mentions that 40 positive specimens were "confirmed and quantified by GC/MS," and it also refers to "Syva EMIT-II" results. GC/MS is a highly accurate analytical method often used as a gold standard, and results from such tests are typically interpreted by trained laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable. The test is a qualitative immunoassay. Ground truth was established by analytical methods (GC/MS, Syva EMIT-II) rather than expert consensus on interpretation of device results requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in-vitro diagnostic device (immunoassay) for drug detection, not an AI-powered image analysis or diagnostic support system that involves human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
The entire performance evaluation can be considered a standalone performance study. The device provides a direct visual result (presence or absence of a line) without immediate human interpretation-in-the-loop for the primary qualitative result. However, as an "immunoassay," a human still reads the visual output, but the "performance" described relates to the device's ability to accurately produce that visual output against known sample concentrations. The device's output itself is the "result."
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for positive samples was established using:
- Syva EMIT-II: An immunoassay widely used for drug screening.
- Gas Chromatography/Mass Spectrometry (GC/MS): A highly sensitive and specific analytical method considered a gold standard for confirming and quantifying drug presence in samples.
Ground truth for negative samples was "drug-free."
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or "validation set" in the context of device development. The performance data presented refers to the evaluation of the final device. For immunoassay development, optimization typically occurs during the R&D phase using various samples, but these are not usually referred to as a "training set" in the same way as machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as a distinct "training set" and its ground truth establishment are not described in the provided information for this type of medical device. The device's immunoassay principles are based on established biochemical reactions, not on learning from a large dataset.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).