(63 days)
'RapidOne'-Ecstasy' Test is used for the qualitative detection of MDMA in human urine. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
'RapidOne-Ecstasy' Test is a one-step, lateral flow immunoassay for the detection of 3,4-methylenedioxymethamphetamine (MDMA or 'Ecstasy') at 1000 ng/ml in urine.
'RapidOne-Ecstasy'-Test is intended for the qualitative detection of MDMA in human urine.
'RapidOne-Ecstasy' Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform and provides a result within 5-10 minutes. 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., GC/MS.
'RapidOue-Ecstasy' Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred chemical method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are use.
The assay employed in the 'RapidOne'-Ecstasy' 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 that 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 a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of a membrane. In the absence of any drug in the urine sample, the colloidal goldantibody moves with the urine by capillary action to contact the immobilized drug conjugate. 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.
The 'RapidOne'-Ecstasy' Test is designed for the qualitative detection of MDMA (Ecstasy) at a cut-off concentration of 1000 ng/ml in human urine. The study compared its performance against a predicate device, the MedTox Verdict II-Methamphetamine Test, and used GC/MS as a confirmatory method for positive results.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative detection of MDMA at 1000 ng/ml cut-off. | Comparison Study: |
- All 50 drug-free samples were correctly identified as negative by both 'RapidOne'-Ecstasy' Test and the predicate device.
- All specimens with MDMA concentrations of 1009 ng/ml or greater were found to be positive by both systems. |
| Reproducibility at concentrations around the cut-off. | Reproducibility Study (80 replicates per concentration): - No drug: 80 Negatives (100% correct)
- 500 ng/ml: 8 Positives, 72 Negatives (8.75% positive, 91.25% negative)
- 750 ng/ml: 40 Positives, 40 Negatives (50% positive, 50% negative)
- 1000 ng/ml (cut-off): 78 Positives, 2 Negatives (97.5% positive, 2.5% negative)
- 1250 ng/ml: 80 Positives, 0 Negatives (100% positive) |
2. Sample size used for the test set and the data provenance:
- Sample Size: 100 samples were used for the comparison study with the predicate device. For the reproducibility study, 80 replicates were run at each of 5 different concentrations, totaling 400 tests.
- Data Provenance: Not explicitly stated, but implies clinical samples used for the comparison. The reproducibility study likely used spiked control urine samples. No country of origin is mentioned, and it is a retrospective analysis of collected samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established by laboratory methods (Syva Emit II for initial screening and GC/MS for confirmation), not by expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable in the traditional sense of human readers adjudicating results. The ground truth for positive samples was confirmed by GC/MS, which is an objective chemical analysis method. For negative samples, the "drug-free" status was initially determined by Syva Emit II.
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:
- This information is not applicable. The 'RapidOne'-Ecstasy' Test is a lateral flow immunoassay, a diagnostic device that directly provides a result, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is partially applicable in the sense that the device itself is a standalone test that produces a result without human interpretation of complex data. However, a human is required to perform the test and observe the line formation. The performance data presented (comparison with predicate and reproducibility) reflects the device's standalone analytical performance.
7. The type of ground truth used:
- Expert Consensus: No
- Pathology: No
- Outcomes Data: No
- Other:
- For identifying "drug-free" samples, Syva Emit II was used.
- For confirming positive results for the amphetamine group and specifically MDMA, GC/MS (Gas Chromatography/Mass Spectrometry) analysis was performed. GC/MS is a highly sensitive and specific analytical technique considered the gold standard for drug confirmation.
8. The sample size for the training set:
- Not applicable. This device is a diagnostic immunoassay that works based on biochemical reactions (antigen-antibody binding), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As stated above, this is not a machine learning device.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).