(487 days)
This device is intended for medical/forensic screening of urine.
TCPI's One Step™ Urine Drug of Abuse Cannabinoids test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
This looks like a 510(k) submission for a drug test, which is a medical device. Here's an extraction of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (NIDA Certified Lab) |
|---|---|
| Sensitivity | 1.00 (100%) |
| Specificity | 0.9935 (99.35%) |
| Accuracy | 0.9967 (99.67%) |
Note: The document implicitly sets high performance standards by comparing to gold standard methods. The "acceptance criteria" are derived from these reported performance metrics, suggesting that meeting or exceeding these levels was expected.
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- In-house testing: 249 individual urine samples. Data provenance is "in house," implying control over the sample collection and characteristics, likely from a lab environment.
- Broader clinical trial: The specific sample size for the "broader clinical trial in a NIDA certified laboratory" is not explicitly stated in the provided text.
- Data Provenance: The broader clinical trial was conducted in a "NIDA certified laboratory," suggesting a focus on samples relevant to drug testing in the United States and likely representing prospective or banked samples from that context. The text does not explicitly state if it was retrospective or prospective, but clinical trials generally involve prospective collection or analysis of existing samples for a specific purpose.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The ground truth was established by "GC/MS" (Gas Chromatography/Mass Spectrometry). This is a laboratory analytical technique, not human experts. Therefore, the concept of "number of experts" and their qualifications doesn't directly apply in this context for establishing the gold standard.
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Adjudication Method for the Test Set:
- There was no mention of an adjudication method involving human reviewers. The gold standard was GC/MS, a definitive analytical method, which would not typically require human adjudication for its results.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The study described compares the device's performance against established analytical methods (Sigma SIA™ THC, Syva Emit, and GC/MS), not against human readers.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone study. The device (One Step™ Urine Drug of Abuse Cannabinoid Test) is a chromatographic absorbent device designed for qualitative testing, meaning it provides a result (presence or absence of drug) without human interpretation of complex images or data. Its performance was measured directly against gold standard laboratory methods.
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The Type of Ground Truth Used:
- The primary ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and definitive analytical method considered a "gold standard" for drug detection and quantification in urine samples. Other reference methods mentioned (Sigma SIA™ THC, Syva Emit) were also used for comparison in the in-house testing.
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The Sample Size for the Training Set:
- The provided text does not explicitly mention a separate "training set" or its sample size. The description focuses on the evaluation of the "final product" using "in house testing" and a "broader clinical trial." For a device like this, the development and optimization (which might be considered analogous to training) would precede the final product testing but are not detailed here.
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How the Ground Truth for the Training Set was Established:
- Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. If development involved iterative testing, it's highly probable that similar laboratory methods like GC/MS would have been used to guide the assay development.
§ 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).