(176 days)
Instant-View Marijuana (THC) Urine Dip StripTest is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9. THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.
The test 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 Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
This test is a one-step lateral flow chromatographic immunoassay.
Here's a breakdown of the acceptance criteria and study information for the Instant-View™ Marijuana (THC) Urine Dip Strip Test, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation of results with legally marketed test device (predicate device) > 98.8% | Higher than 98.8% |
| Overall agreement from accuracy evaluation (clinical lab & three physician's offices) | Greater than 95.9% |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "clinical laboratory & three physician's office laboratory" but does not give the number of samples tested in these settings.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be from a clinical laboratory and three physician's office laboratories, implying real-world testing. It is implicitly retrospective as it compares with an existing legally marketed device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this type of immunoassay is typically established by comparing the device's output to a confirmed analytical method (like GC/MS). Human experts are not used to establish the ground truth in this context, but rather to interpret the device's results.
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Adjudication method for the test set:
- Not applicable. This is a diagnostic device that provides a qualitative result. Adjudication methods like 2+1 are typically used for subjective assessments (e.g., image interpretation), not for objective test results.
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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:
- Not applicable. This is a standalone diagnostic test (dip strip) and does not involve human readers interpreting complex cases or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. The "accuracy evaluation from the clinical laboratory & three physician's office laboratory" assesses the device's performance directly against established methods, not in conjunction with human interpretation for performance enhancement. The interpretation of the dip strip (lines appearing or not) is a straightforward visual assessment by a healthcare professional, not an "algorithm" in the sense of AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used for confirmation is alluded to: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method." This indicates that the true presence or absence of THC at the specified cutoff is determined by a highly accurate analytical method like GC/MS.
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The sample size for the training set:
- Not applicable. This type of immunoassay (dip strip) does not typically involve a "training set" in the machine learning sense. The device is designed and manufactured based on immunological principles, and its performance is validated through testing, not iterative training.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device. The device's inherent design for detecting THC at 50 ng/ml is based on established biochemical reactions, and its accuracy is verified through comparison with a gold standard analytical method on test samples.
§ 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).