(28 days)
BIOEASY Marijuana Test Dip Card 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 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 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 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 Dip Card 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 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 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 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
Here's an analysis of the provided document to extract the acceptance criteria and study details:
Device: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (Cannabinoid test system)
Indications for Use: Qualitative detection of Marijuana (THC) in human urine at cutoff concentrations of 20 ng/mL or 40 ng/mL. Provides preliminary test results, requiring GC/MS or LC/MS for confirmation. For in vitro diagnostic use only.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics that collectively demonstrate acceptable performance for substantial equivalence. The precision studies, in particular, provide detailed performance around the cut-off concentrations, which are key to evaluating the device.
Based on the precision data, the performance of the device is evaluated against its ability to correctly identify positive and negative samples at various concentrations relative to the cutoff. The data suggests that at -25% to +25% of the cutoff concentration, there is variability, but at concentrations definitively below (-50% or less) or above (+50% or more) the cutoff, the device shows 100% agreement with the expected outcome.
Here's a summary derived from the precision study results:
| Performance Metric (Derived from Precision Study) | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Precision (at 20 ng/mL Cut-off) | ||
| Negatives (-75% to -100% cutoff) | 100% negative results | Dip Card 20ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off. |
| Strip 20ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off. | ||
| Positives (+75% to +100% cutoff) | 100% positive results | Dip Card 20ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off. |
| Strip 20ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off. | ||
| Near Cutoff (-25%) | Majority negative, some positive acceptable (demonstrates functionality near threshold) | Dip Card 20ng/mL: Lot 1: 58-/2+, Lot 2: 59-/1+, Lot 3: 59-/1+ (Total 176-/4+). |
| Strip 20ng/mL: Lot 1: 59-/1+, Lot 2: 58-/2+, Lot 3: 59-/1+ (Total 176-/4+). | ||
| Near Cutoff (+25%) | Majority positive, some negative acceptable (demonstrates functionality near threshold) | Dip Card 20ng/mL: Lot 1: 59+/1-, Lot 2: 59+/1-, Lot 3: 58+/2- (Total 176+/4-). |
| Strip 20ng/mL: Lot 1: 58+/2-, Lot 2: 58+/2-, Lot 3: 57+/3- (Total 173+/7-). | ||
| At Cutoff | Approximately 50% positive, 50% negative (demonstrates accurate cutoff performance) | Dip Card 20ng/mL: Lot 1: 32-/28+, Lot 2: 29-/31+, Lot 3: 30-/30+ (Overall close to 50/50 split). |
| Strip 20ng/mL: Lot 1: 30-/30+, Lot 2: 32-/28+, Lot 3: 31-/29+ (Overall close to 50/50 split). | ||
| Precision (at 40 ng/mL Cut-off) | ||
| Negatives (-75% to -100% cutoff) | 100% negative results | Dip Card 40ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off. |
| Strip 40ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off. | ||
| Positives (+75% to +100% cutoff) | 100% positive results | Dip Card 40ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off. |
| Strip 40ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off. | ||
| Near Cutoff (-25%) | Majority negative, some positive acceptable | Dip Card 40ng/mL: Lot 1: 59-/1+, Lot 2: 57-/3+, Lot 3: 58-/2+ (Total 174-/6+). |
| Strip 40ng/mL: Lot 1: 58-/2+, Lot 2: 59-/1+, Lot 3: 58-/2+ (Total 175-/5+). | ||
| Near Cutoff (+25%) | Majority positive, some negative acceptable | Dip Card 40ng/mL: Lot 1: 58+/2-, Lot 2: 59+/1-, Lot 3: 59+/1- (Total 176+/4-). |
| Strip 40ng/mL: Lot 1: 59+/1-, Lot 2: 57+/3-, Lot 3: 58+/2- (Total 174+/6-). | ||
| At Cutoff | Approximately 50% positive, 50% negative | Dip Card 40ng/mL: Lot 1: 31-/29+, Lot 2: 28-/32+, Lot 3: 29-/31+ (Overall close to 50/50 split). |
| Strip 40ng/mL: Lot 1: 32-/28+, Lot 2: 29-/31+, Lot 3: 31-/29+ (Overall close to 50/50 split). | ||
| Analytical Specificity (Cross-Reactivity) | Detect THC and its main metabolites. Limited cross-reactivity with other substances (ideally = +50% Cut-Off and all negative for samples 95%) for clearly positive/negative samples, some discordance expected near cutoff relative to the confirmatory method. | Dip Card & Strip 20ng/mL: For each of 3 operators, out of 80 samples (40 neg, 40 pos): |
- 6 Negative clinical samples: 6/6 Negative (100%)
- 16 Low Negative clinical samples: 16/16 Negative (100%)
- 20 High Positive clinical samples: 20/20 Positive (100%)
- Near Cutoff Negative (15-16 samples): ~15/16 Negative, with 2-3 Positive discordant.
- Near Cutoff Positive (18-19 samples): ~18/19 Positive, with 1-2 Negative discordant.
Dip Card & Strip 40ng/mL: Similar high agreement at clear negative/positive ranges. |
2. Sample Size Used for the Test Set and Data Provenance
Precision Study (Analytical Performance):
- Sample Size: For each concentration level (e.g., -100% cutoff, +25% cutoff, etc.), tests were performed six runs per day for 10 days per device lot, and there were three device lots.
- This equates to 6 runs/day * 10 days * 3 lots = 180 tests for each concentration level (e.g., 180 tests at -100% cut-off, 180 tests at +25% cut-off, etc.). There are 9 concentration levels, so theoretically 1,620 tests for each device type (Dip Card 20, Strip 20, Dip Card 40, Strip 40).
- Data Provenance: Samples were prepared by spiking 11-Nor-Δ9-THC-9-COOH in negative samples. These appear to be spiked laboratory samples, not clinical samples from a specific country or population. The study is prospective in execution once samples are prepared.
Method Comparison Study:
- Sample Size: 80 "unaltered clinical samples" were used for each device format (Dip Card 20, Strip 20, Dip Card 40, Strip 40). These 80 samples consisted of 40 negative and 40 positive samples.
- Data Provenance: The samples were described as "unaltered clinical samples." The country of origin is not specified but it's an "in-house" study, suggesting it was conducted by the manufacturer or a laboratory they contracted. The study is retrospective as it uses pre-collected clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Precision Study:
- Ground Truth Establishment: The ground truth for the spiked samples was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly accurate analytical method.
- Number of Experts/Qualifications: The document does not specify "experts" in the traditional sense of human readers. The "ground truth" here is the LC/MS result, which is an objective chemical measurement. The person who prepared the samples (spiking them) and confirmed concentrations by LC/MS was different from the person who tested them to ensure blinding. No specific qualifications are given for these individuals, but it implies laboratory personnel competent in preparing and analyzing such samples.
Method Comparison Study:
- Ground Truth Establishment: The ground truth for the clinical samples was established by LC/MS results.
- Number of Experts/Qualifications: Similar to the precision study, the ground truth is an objective chemical measurement (LC/MS), not a human expert interpretation of the device's results.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for both the precision and method comparison studies relies on LC/MS as the objective standard. The device's results are compared directly to the LC/MS results. There is no mention of human-based adjudication for ground truth establishment. For the method comparison study, three laboratory assistants performed the readings, and their individual results were compared to LC/MS, but this is a comparison to a known truth, not an adjudication process to establish the truth itself.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly performed as described for AI vs. human readers. The study involves multiple operators (three laboratory assistants) reading multiple cases (80 clinical samples each) in the "Comparison Studies" section. However, this is a comparison of the device's standalone performance (as read by laboratory assistants) against a gold standard (LC/MS), not a study to evaluate human readers' improvement with AI assistance versus without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire set of performance characteristics outlined (Precision, Specificity, Interference, Effect of Urine Specific Gravity and pH, and Comparison Studies) represents the standalone performance of the BIOEASY Marijuana Test devices.
The "Comparison Studies" explicitly show the device's results (as interpreted by laboratory assistants) compared against the LC/MS ground truth, demonstrating its accuracy without human-in-the-loop intervention for decision making beyond reading the visual result.
7. Type of Ground Truth Used
The type of ground truth used is objective chemical analysis (LC/MS).
- For the precision studies, 11-Nor-Δ9-THC-9-COOH was spiked into negative samples at known concentrations, and these concentrations were confirmed by LC/MS.
- For the method comparison studies, the "unaltered clinical samples" were independently analyzed by LC/MS to establish their true drug concentration.
8. Sample Size for the Training Set
The document describes the device as an "immunochromatographic assay," which is a biochemical test, not an AI or machine learning device. Therefore, there is no training set in the context of machine learning. The device's performance is based on its chemical reactions and design.
9. How the Ground Truth for the Training Set Was Established
As the device is not an AI/machine learning product, there is no "training set" and thus no ground truth establishment for a training set in this context.
§ 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).