(256 days)
'RapidOne' - Barbiturate Test is a one-step, lateral flow immunoassay for the detection of barbiturate in urine. 'RapidOne' - Barbiturate Test is intended for use in the qualitative detection of secobarbital in human urine at 300 ng/ml.
'RapidOne' - Barbiturate 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' - Barbiturate 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'- Barbiturate 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 or 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device's intended performance is to accurately detect secobarbital in urine at a specific cut-off concentration. The key acceptance criterion is the ability to correctly identify positive and negative samples around this cut-off.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detect 300 ng/ml of secobarbital in urine. | Comparison Study: 'RapidOne'-Barbiturate Test correctly identified all 40 drug-containing specimens (ranging from 310 ng/ml to 10000 ng/ml) as positive. It also correctly identified all 50 drug-free specimens as negative. |
Reproducibility Study:
- At 0 ng/ml: 40/40 negative (>99% precision)
- At 150 ng/ml: 40/40 negative (>99% precision)
- At 225 ng/ml: 32/40 positive (>20% precision) - Note: This concentration is below the stated 300 ng/ml cut-off, so some negative results are expected and acceptable if the device is designed to be highly sensitive at 300ng/ml. However, the precision value is low and indicates variability close to the cut-off.
- At 300 ng/ml: 40/40 positive (>99% precision)
- At 375 ng/ml: 40/40 positive (>99% precision) |
| Qualitative detection of secobarbital. | The device is described as a "simplified qualitative screening method." The performance data demonstrates its ability to categorize samples as positive or negative based on the presence of secobarbital above the cut-off. |
| Substantial equivalence to predicate device. | The conclusion states that 'RapidOne'-Barbiturate Test is substantially equivalent to 'Instacheck' - Drug Screen - Barbiturate Test. The comparison study results support this by showing similar performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Comparison Study:
- Sample Size: 90 samples (50 drug-free, 40 drug-containing).
- Data Provenance: Not explicitly stated, but given context of FDA submission, likely from a US-based laboratory or clinical setting. The study used samples that had been tested by "Syva EMIT-II" and confirmed by "GC/MS," suggesting human biological samples. It's a retrospective analysis of previously collected and analyzed samples for the comparison study.
- Reproducibility Study:
- Sample Size: For each concentration level (0, 150, 225, 300, 375 ng/ml), 40 tests were performed (4 times daily for 5 days). This implies that a set of control urines (presumably pooled or spiked samples) were tested multiple times, not 40 individual patient samples per concentration.
- Data Provenance: "Control urines containing concentrations above and below the stated cut-off. Negative urines were also used." These are likely lab-prepared or spiked samples, not individual patient samples. This is a prospective experimental study conducted in a controlled lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Comparison Study Ground Truth: The ground truth for the 40 positive samples was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for drug quantification. The number of "experts" is not applicable in the human-reader sense, as GC/MS is an objective analytical measurement. However, qualified laboratory personnel would have conducted and interpreted the GC/MS results.
- Reproducibility Study Ground Truth: The ground truth was established by the known, spiked concentrations of secobarbital in the control urines.
4. Adjudication Method for the Test Set
- Comparison Study: Not explicitly an adjudication process involving human reviewers for the device's results. The 'RapidOne' results were directly compared to the GC/MS confirmed results.
- Reproducibility Study: No adjudication method mentioned, as the results were direct measurements against known concentrations.
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
- No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-powered image analysis or diagnostic tool that assists human readers. Its output is a direct qualitative result (positive/negative line on a strip), not input for human interpretation that would be enhanced by AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Yes, a standalone study was done. The entire performance characterization (comparison and reproducibility studies) is based on the 'RapidOne' device's performance by itself, without human-in-the-loop assistance for interpretation beyond reading the visible lines. The device provides a direct qualitative result.
7. The Type of Ground Truth Used
- Comparison Study: Analytical Gold Standard (GC/MS) for the positive samples and presumed verified drug-free status for the negative samples.
- Reproducibility Study: Known, spiked concentrations in control urines.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This device is an immunoassay, not a machine learning or AI-based device that typically requires a distinct "training set" in the computational sense. Its design and cutoff are based on established biochemical principles and analytical performance targets.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided. As noted above, there isn't a "training set" in the typical AI/ML context. The device's operating characteristics (e.g., antibody specificity, concentration of reagents) are determined during its development based on chemical and biological principles and then validated through performance studies like those described.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).