(118 days)
'RapidOne' - Marijuana Test is a one-step, lateral flow immunoassay for the detection of marijuana in urine. 'RapidOne' - Marijuana Test is intended for use in the qualitative detection of marijuana metabolite, 11-nor-9-carboxy-delta-9-THC in human urine at 50 ng/ml.
'RapidOne' - Marijuana 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) or HPLC.
'RapidOne' - Marijuana 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'- Marijuana Test is based on the same principle of highly specific reaction between antigens and antibodies.
Each 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 a drug conjugate has been immobilized. 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. 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.
Here's a breakdown of the acceptance criteria and study information for the 'RapidOne' - Marijuana Test, based on your provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative detection of 11-nor-9-carboxydelta-9-THC in human urine at 50 ng/ml. | Comparison to Predicate Device: Both immunoassays (RapidOne and Instacheck) correctly identified all 50 drug-free specimens as negative and all 40 drug-containing specimens (concentrations 39 ng/ml to 2200 ng/ml) as positive. |
| Reproducibility (Cut-off 50 ng/ml): |
- 0 ng/ml: 40/40 negative (>99% precision)
- 37.5 ng/ml: 32/40 positive (20% precision) (Note: This is below cut-off, so some negative results are expected due to competitive binding near the threshold)
- 50.0 ng/ml: 40/40 positive (>99% precision)
- 75.0 ng/ml: 40/40 positive (>99% precision) |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 90 samples (50 drug-free, 40 drug-containing).
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission for a US market, it's highly likely to be U.S.-based. The study appears to be retrospective, as samples were "selected for evaluation" and 40 positive specimens were "confirmed and quantified by GC/MS," implying prior testing.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not specified.
- Qualifications: "Syva EMIT-II" was used for initial classification, and "GC/MS" was used for confirmation and quantification of positive samples. These are laboratory-based, instrumental methods. No human expert interpretation of the initial Syva EMIT-II or GC/MS results is mentioned for establishing ground truth; rather, the results of these analytical methods themselves serve as the ground truth.
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Adjudication Method for the Test Set:
- No explicit adjudication method (like 2+1, 3+1) is mentioned. The ground truth for positive samples was established by "Syva EMIT-II" and "confirmed and quantified by GC/MS." For negative samples, it was just "found to be drug-free" (presumably by Syva EMIT-II).
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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 study was not done. This device is a rapid immunoassay kit, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The device's performance was compared to the predicate device and benchmarked against GC/MS for positive samples. The "RapidOne" test itself is a standalone qualitative screening method.
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The Type of Ground Truth Used:
- Analytical/Laboratory Ground Truth:
- For positive samples: Confirmed and quantified by Gas Chromatography/Mass Spectrometry (GC/MS).
- For negative samples: Identified as "drug-free" (presumably by a validated method like Syva EMIT-II).
- Analytical/Laboratory Ground Truth:
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The Sample Size for the Training Set:
- The document does not specify a separate training set. The descriptions relate to performance evaluation and reproducibility, implying these samples are part of a verification/validation set rather than a training set for a machine learning model. This is an immunoassay device, which typically does not involve machine learning training in the same way an AI algorithm would.
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How the Ground Truth for the Training Set was Established:
- As no separate training set is explicitly mentioned for a machine learning model, this question is not applicable to the provided document. The device's design is based on established immunoassay principles.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).