(28 days)
BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BIOEASY Marijuana Test Strip is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
The BIOEASY Marijuana Test Dip Card and the BIOEASY Marijuana Test Strip tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.
This document describes the performance characteristics and acceptance criteria for the BIOEASY Marijuana Test Dip Card and BIOEASY Marijuana Test Strip.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for qualitative immunoassay devices like these are typically based on achieving a certain level of agreement with a reference method (LC/MS in this case) across different concentration ranges relative to the cutoff, and demonstrating reliable performance under various conditions.
Since the document does not explicitly state "acceptance criteria" numerical targets, these are inferred from the presented data, aiming for high agreement, especially at concentrations away from the cutoff, and demonstrating appropriate performance near the cutoff.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (BIOEASY Marijuana Test Dip Card / Strip) |
|---|---|---|
| Precision | High agreement (ideally 100% Negative or 100% Positive) for samples far from the cutoff (-100%, -75%, -50% cut off; +50%, +75%, +100% cut off). Acceptable distribution of results (both positive and negative) for samples at the cutoff (50 ng/mL), reflecting the qualitative nature and inherent variability around the cutoff. | Dip Card: |
| -100% to -25% Cutoff: 100% Negative (200/200 total per lot). | ||
| +25% to +100% Cutoff: 100% Positive (200/200 total per lot). | ||
| At Cutoff: Mixture of Positive/Negative (25-/25+, 23-/27+, 24-/26+ for Lot 1, 2, 3 respectively). | ||
| Strip: | ||
| -100% to -25% Cutoff: 100% Negative (200/200 total per lot). | ||
| +25% to +100% Cutoff: 100% Positive (200/200 total per lot). | ||
| At Cutoff: Mixture of Positive/Negative (19-/31+, 28-/22+, 23-/27+ for Lot 1, 2, 3 respectively). | ||
| Specificity | No interference from common physiological and pathological substances found in urine. Limited or no cross-reactivity with structurally similar compounds at high concentrations, or clear explanation of cross-reactivity at specified concentrations. | Interference: No interference observed at specified concentrations for a wide range of common substances (e.g., albumin, ethanol, acetaminophen, ibuprofen). |
| Cross-Reactivity: | ||
| 100% to 11-nor-Δ9-THC-9-COOH, 11-Hydroxy-Δ9-Tetrahydrocannabinol, 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH, (-)-11-nor-9-carboxy-Δ9-THC at 50 ng/mL. | ||
| Lower cross-reactivity for Cannabinol (0.25%), Δ8-Tetrahydrocannabinol (0.33%), Δ9-Tetrahydrocannabinol (0.33%) at significantly higher concentrations (15000-20000 ng/mL). | ||
| Cannabidiol (100000 ng/mL). | ||
| 11-Nor-Δ9-THC-carboxy glucuronide (66.7% at 75 ng/mL). | ||
| Effect of Urine SG & pH | Reliable performance (correct result relative to cutoff) across a range of urine specific gravity (SG) and pH values. | Specific Gravity: Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off for SG range of 1.000 to 1.035. |
| pH: Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off for pH range of 4 to 9. | ||
| Method Comparison (Analytical Accuracy) | High agreement with LC/MS (gold standard) for samples categorized as "Negative," "Low Negative," "High Positive." A reasonable number of discordant results are expected at "Near Cutoff" concentrations, reflecting the inherent variability of qualitative assays around the cutoff. | Strip Format: |
| Negative, Low Negative, High Positive LC/MS categories show high agreement across viewers (e.g., Viewer A: 6/6 Negatives, 14/14 Low Negatives, 18/18 High Positives). | ||
| Near Cutoff Negative and Positive categories show some discordance (e.g., Viewer A: 1 Positive out of 20 Near Cutoff Negatives, 1 Negative out of 22 Near Cutoff Positives). | ||
| Dip Card Format: Similar high agreement for clear negative/positive samples and expected discordance near cutoff. | ||
| Lay-User Study Performance | High percentage of correct results when used by lay persons, demonstrating ease of use and interpretability of results as per the Instructions For Use (IFU). Acceptable performance around the cutoff. User surveys confirm ease of understanding IFU. | Strip & Dip Card: |
| -100%, -75%, -50% Cutoff: 100% correct results. | ||
| -25% Cutoff: 95% (Strip) and 90% (Dip Card) correct results (1-2 false positives out of 20). | ||
| +25% Cutoff: 90% correct results (2 false negatives out of 20). | ||
| +50%, +75% Cutoff: 100% correct results. | ||
| Lay-user surveys: All users indicated instructions were easily followed (Grade Level 7 Flesch-Kincaid). | ||
| Stability | Devices remain stable and perform within acceptance criteria over the claimed shelf-life under specified storage conditions. | Stable at 4-30 ℃ for 24 months based on accelerated stability at 45 ℃ and real-time stability at 4 ℃ and 30 ℃. |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Precision Studies:
- For each of the 8 concentration points (ranging from -100% of cutoff to +100% of cutoff) relative to the 50 ng/mL cutoff, 50 tests were performed per concentration point for each of the 3 lots.
- Total tests for Precision: 8 concentrations x 50 tests/concentration x 3 lots = 1200 tests per device format (Dip Card and Strip).
- Data Provenance: Samples were "prepared by spiking 11-Nor-△9-THC-9-COOH in negative samples." The document does not specify the country of origin but implies laboratory-prepared samples. It's a prospective study on prepared samples.
-
Interference Studies:
- Tested at 25% below and 25% above cutoff with various interfering substances.
- "Three batches of each device" were used. The number of samples for each interfering substance is not explicitly stated but implied to be sufficient for testing.
-
Specificity Studies (Cross-Reactivity):
- Various drug metabolites and other components were tested.
- "Three batches of each device format" were used. The number of tests per compound is not explicitly stated.
-
Effect of Urine Specific Gravity and pH:
- Tested at 25% below and 25% above cutoff with varying SG and pH.
- "Three lots of each device format" were used. The number of samples per condition is not explicitly stated.
-
Method Comparison Studies (Analytical Accuracy):
- 80 "unaltered clinical samples" were used for each device format (40 negative and 40 positive).
- Data Provenance: "Clinical samples." No country of origin is specified. The study is retrospective in the sense that samples were collected and then tested.
-
Lay-User Study:
- 280 lay persons participated.
- 7 concentration points were tested (negative, +/-75%, +/-50%, +/-25% of the cutoff).
- For each concentration point, 20 samples were tested.
- Total tests: 7 concentrations x 20 samples/concentration = 140 samples per device format.
- Data Provenance: Urine samples were "prepared by spiking 11-Nor-△9-THC-9-COOH into drug free-pooled urine specimens." The location of the lay-user study is described as "three intended user sites," but no specific country is mentioned. This is a prospective study on prepared samples with lay users.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Analytical Ground Truth:
- For the precision, interference, specificity, and lay-user studies, the ground truth for spiked samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is a highly accurate and specific analytical method.
- For the method comparison study, "LC/MS results" were used as the gold standard for classifying clinical samples.
- No human experts were explicitly "establishing" ground truth in terms of diagnostic interpretation; rather, the ground truth was based on the objective, quantitative results of LC/MS.
4. Adjudication Method for the Test Set
- Analytical Studies (Precision, Interference, Specificity, SG/pH): No adjudication method is mentioned or needed as the results are quantitative and read as positive/negative based on the device's qualitative nature. The preparation and blinding for precision studies suggest a robust method.
- Method Comparison Study: The document states, "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results." "Viewer A, B, C" for the strip and "Viewer D, E, F" for the dip card were the "laboratory assistants." The data are presented per viewer, implying individual results were compared to LC/MS. There is no mention of an adjudication process for discordant results among the viewers or between the device results and LC/MS. The discordant results are simply listed.
- Lay-User Study: No adjudication. The results are presented as the "No. of Positive" and "No. of Negative" given by the lay persons, compared to the known spiked concentration verified by LC/MS.
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 document describes the validation of a qualitative in-vitro diagnostic device (Marijuana Test Dip Card/Strip) for detecting Marijuana in urine directly by human observation of lines on a test strip/card. There is no AI component involved, so no study on AI assistance or human reader improvement with AI can be conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a manual, visually read immunoassay. There is no algorithm or automated reading component. The "standalone" performance is simply the device's ability to produce a correct result when used as intended and read by a human. The "Method Comparison Studies" and "Precision Studies" essentially demonstrate the standalone performance of the device itself (though still read by human operators).
7. The Type of Ground Truth Used
- The primary ground truth used for all performance studies (precision, method comparison, lay-user study) was analytical confirmation by LC/MS (Liquid Chromatography/Mass Spectrometry). This is considered a gold standard for quantitative drug concentration measurement.
- For interference and specificity, the ground truth was based on the known presence/absence and concentration of the spiked substances.
8. The Sample Size for the Training Set
- This document describes performance validation studies for a medical device (Marijuana Test Dip Card/Strip). These types of devices are not typically "trained" in the machine learning sense. Therefore, there is no "training set" in the context of an AI/ML model for this device. The data presented are for demonstrating the device's analytical and clinical performance.
9. How the Ground Truth for the Training Set Was Established
- As there is no AI/ML component and thus no "training set," this question is not applicable. The ground truth for the test samples (used for validation) was established using LC/MS.
§ 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).