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BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Marijuana (THC): 50 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Cannabinoids (THC): 50 ng/mL
6-Acetylmorphine: 10 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

The BIOEASY™ U-Catch MAX Multi-Drug Test Cup and BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The BIOEASY™ U-Catch MAX Multi-Drug Test Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

Here's a detailed breakdown of the acceptance criteria and study information for the BIOEASY™ U-Catch MAX Multi-Drug Test Cup, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For the purpose of this analysis, the "acceptance criteria" are not explicitly defined as pass/fail thresholds in the provided document, but rather implied by the successful demonstration of performance metrics. The "reported device performance" refers to the results obtained from the various analytical and lay-user studies.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Precision Studies: For each of the 5 new analytes (AMP, COC, MET, EDDP, 6-AM), 9 concentrations were tested across 3 lots. Each concentration was tested two runs per day for 25 days. Total samples for precision: 5 analytes * 9 concentrations * 3 lots * 25 days * 2 runs/day = 6,750 individual tests.
  • Method Comparison Studies: For each of the 5 new analytes, 80 unaltered clinical samples (40 negative and 40 positive) were tested. Total samples for method comparison: 5 analytes * 80 samples = 400 clinical samples.
  • Lay-User Study: 140 lay persons. Each participant (lay person) received one blind-labeled sample and a device. For each of the 15 analytes, there were 7 concentration levels tested, with 20 samples per level. Total unique tests performed by lay users: 15 analytes * 7 concentration levels * 20 samples/level * 1 device/sample = 2,100 tests.
• Data Provenance:
  • Precision Studies: Samples were prepared by spiking drug in negative urine samples. "Each drug concentration was confirmed by LC/MS." This suggests prepared samples, not necessarily clinical samples.
  • Method Comparison Studies: Unaltered clinical samples. The country of origin is not specified but is likely from the United States given the FDA submission context. The study is retrospective as these were "unaltered clinical samples" which typically implies pre-collected samples.
  • Lay-User Study: Urine samples were prepared at various concentrations by spiking drugs into drug-free pooled urine specimens. The concentrations were confirmed by LC/MS. This indicates a controlled, prospective study design using artificially prepared (but LC/MS confirmed) samples. Country of origin not explicitly stated, but performed at "three intended user sites" which likely corresponds to a US setting for OTC validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Precision Studies: Ground truth (drug concentration) was established by LC/MS. The document states that "Each drug concentration was confirmed by LC/MS," indicating a highly accurate analytical method. This method does not typically involve human experts for interpretation in the same way clinical imaging or pathology might.
• Method Comparison Studies: Ground truth was established by LC/MS results. The study directly compared the device results to LC/MS results. Again, this is an analytical method, not requiring expert human interpretation from a medical perspective (like radiologists).
• Lay-User Study: Ground truth (drug concentration) was established by LC/MS. "The concentrations of the samples were confirmed by LC/MS." No medical experts were involved in establishing the ground truth for these samples. The "experts" in this context were the personnel operating the LC/MS equipment, who would be trained lab technicians or chemists.

4. Adjudication Method for the Test Set

• Precision Studies: No explicit adjudication method described. The results are quantitative (expressed as number of positive/negative readings) and directly compared to the known LC/MS concentration of the spiked samples.
• Method Comparison Studies: No explicit adjudication method described beyond direct comparison to LC/MS results. Discordant results are individually listed but not subject to a separate adjudication process beyond the LC/MS reference.
• Lay-User Study: No explicit adjudication method described. Lay person results were directly compared to the known (LC/MS confirmed) concentration of the samples. The primary focus for the lay-user study appears to be the percentage of correct results at various concentrations, not reconciliation of disagreements between readers or methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done in the conventional sense of human readers interpreting medical images or data with and without AI assistance.
• The "Method Comparison Studies" involved three laboratory assistants as "viewers" interpreting the test cups. This could be considered a multi-reader study, but it was comparing the device's performance to LC/MS as a reference, not comparing human readers' performance with and without AI.
• The "Lay-user study" involved 140 lay persons interpreting the device. This is a multi-reader study for ease of use and interpretation, but not focused on clinical comparative effectiveness against experts or AI assistance.
• Therefore, no effect size for human readers improving with AI vs without AI assistance can be reported from this document as the device is a drug test cup, not an AI diagnostic tool and the studies were not designed for this type of comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The device described is a "competitive binding, lateral flow immunochromatographic assay" in the form of a "Multi-Drug Test Cup." This is a physical or chemical diagnostic test, not a software algorithm or AI.
• Therefore, the concept of a "standalone algorithm" does not apply here. The device itself is the standalone test that produces a visual result (a line or absence of a line). Its performance is its standalone performance. The "human-in-the-loop" here refers to the human interpreting the visual result, which is evaluated in the lay-user study.

7. The Type of Ground Truth Used

• The primary ground truth used across all analytical performance studies (Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH) and the Method Comparison Studies was LC/MS (Liquid Chromatography/Mass Spectrometry).
• For the Lay-User Study, the ground truth for spiked samples was also established by LC/MS.

8. The Sample Size for the Training Set

• No explicit training set is mentioned in the context of this device. This is because the BIOEASY™ U-Catch MAX Multi-Drug Test Cup is a lateral flow immunoassay, which is a chemical/biological test, not a machine learning or AI model that requires a "training set" in the computational sense. The device is developed and validated through laboratory experimentation and calibration rather than a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

• As there is no "training set" in the context of a machine learning or AI model, this question is not applicable. The performance characteristics were established through standard laboratory testing procedures using known concentrations of analytes, confirmed by LC/MS.

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BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical 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 Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch

The provided document describes the performance of the BIOEASY Multi-Drug Test Cup, an in-vitro diagnostic device for qualitative and simultaneous detection of various drugs in human urine. Here's a breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a separate table. However, the performance is demonstrated through precision studies and lay-user studies, showing the device's ability to correctly identify drug presence/absence at specific concentrations relative to the defined cutoff levels. The implicit acceptance criteria appear to be high percentages of correct results, particularly at and beyond the +/- 25% cutoff concentrations. For the lay user study, 90-100% correct results were generally achieved across different drug panels and concentrations close to the cutoff, with 100% correct results for samples far from the cutoff.

Here's an aggregated summary of the performance for each drug panel from the lay user study, which serves as a key indicator of device performance in the hands of intended users:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Studies: For each drug concentration point tested (-100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off, and +100% cut off), tests were performed for 25 days per device, with two runs per day for each drug. This means 50 runs per concentration for each drug across three lots (total of 150 runs per concentration per drug across lots). The samples were prepared in-house by spiking drugs into negative samples. The data provenance is implied to be from the manufacturer's lab, likely Shenzhen, China, where the submitter is located. This appears to be a prospective internal study.
• Method Comparison Studies: 80 (40 negative and 40 positive) unaltered clinical samples for each drug were used. The samples were blind labeled. These appear to be retrospective clinical samples, but the country of origin is not specified.
• Lay-user Study: 300 lay persons participated. Urine samples were prepared at varying concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff. Each participant received one blind-labeled sample and one device. The number of samples tested at each concentration varied per drug, as shown in the tables (e.g., 20 samples for -100% cutoff, 160 for -50% cutoff, 40 for +50% cutoff). These were likely prepared in-house or externally for the study, making it a prospective study, though the country of origin for the lay users is not specified (but likely related to the submitter's regions of operation or intended market).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Precision and Lay-user Studies: The "ground truth" for the urine samples in these studies was established by LC/MS (Liquid Chromatography/Mass Spectrometry) or LC/MS/MS, which is a gold standard analytical method for drug concentration determination. The number or qualifications of the individuals performing the LC/MS analysis are not specified, but it's presumed to be trained laboratory personnel.
• Method Comparison Studies: The ground truth for the 80 clinical samples was also established by LC/MS. The number or qualifications of the individuals performing the LC/MS analysis are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Precision Studies: The document doesn't explicitly state an adjudication method. "All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing." The results presented are counts of "positive" and "negative" outcomes.
• Method Comparison Studies: The studies were performed in-house with three laboratory assistants for each device. The results are summarized by "Viewer A," "Viewer B," and "Viewer C." This indicates a multi-reader approach. However, there's no mention of an adjudication process (e.g., 2+1, 3+1) if their readings disagreed. The discordant results table lists individual discrepancies.
• Lay-user Study: Each participant tested one device and recorded their results. The assessment of whether their result was "correct" was based on the LC/MS confirmed concentration of the sample they received. No adjudication among lay users is mentioned or appropriate for this type of study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This device is a lateral flow immunoassay, a point-of-care test that human users (including lay users) interpret visually. It is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done, as this device does not incorporate an AI algorithm. Its performance is based on the chemical reaction and visual interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for validating the device's performance was primarily analytical confirmation by LC/MS or LC/MS/MS. This is considered a highly accurate and quantitative laboratory diagnostic method for determining drug concentrations.

8. The sample size for the training set

The document does not describe a "training set" in the context of an AI/ML algorithm. This device is a lateral flow immunoassay and does not employ machine learning or AI that would require a separate training dataset. The studies described are for analytical and clinical validation of the immunoassay.

9. How the ground truth for the training set was established

As there is no AI/ML component mentioned and thus no "training set," this question is not applicable to the information provided.

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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:

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.

Ask a specific question about this device

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.

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.

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BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical 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 Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful outcomes of the various performance studies. The reported device performance is excellent, demonstrating near-perfect agreement with the LC/MS ground truth for samples outside the +/-25% cutoff range, and reasonable agreement within the +/-25% cutoff range, which is expected for qualitative tests around the cutoff.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Studies:

  • For each of the 14 analytes, 8 concentrations were tested (ranging from -100% cut off to +100% cut off).
  • For each concentration, tests were performed two runs per day for 25 days, using 3 different lots of the device.
  • Total samples per lot per concentration: 50 (2 runs/day * 25 days).
  • Total samples per drug per concentration for 3 lots: 150 (50 * 3 lots).
  • Total samples per drug: 1,200 (150 * 8 concentrations).
  • Total samples for all 14 drugs in precision study: 16,800.
  • Data Provenance: The text does not explicitly state the country of origin but implies it was performed "in-house" by the manufacturer (Shenzhen Bioeasy Biotechnology Co., Ltd. in China). These samples were prepared by spiking drug in negative samples. The study appears to be prospective in nature for the purpose of device validation.

• Interference & Specificity Studies:

  • "Three batches of each device" were used.
  • The number of individual samples tested for each interfering substance or cross-reactant is not explicitly stated, but it involved "drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels."

• Effect of Urine Specific Gravity and pH:

  • "Three lots of each device" were used.
  • "Urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels." The exact number of samples at each specific gravity/pH level is not detailed.

• Method Comparison (Professional User) Studies:

  • For each of the 14 analytes: 80 unaltered clinical samples (40 negative and 40 positive).
  • Total samples for 14 drugs: 1120 samples.
  • Data Provenance: "clinical samples" are mentioned, but their country of origin is not specified. The study is retrospective, as these are "unaltered clinical samples" compared to LC/MS results.

• Lay-user Study:

  • 300 lay persons were involved.
  • The text describes sample numbers for various concentrations. For each drug, a total of 300 samples were prepared the following way: 20 at -100% Cutoff, 20 at -75%, 160 at -50%, 20 at -25%, 20 at +25%, 40 at +50%, 20 at +75%.
  • Total samples per drug: 300.
  • Total samples for all 14 drugs in lay-user study: 4,200.
  • Data Provenance: The text does not explicitly state the country of origin for the urine samples, but the study was conducted at "three intended user sites." These samples were prepared by spiking drugs into drug-free pooled urine specimens. The study itself is prospective in terms of collecting performance data from lay users.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Method Comparison Studies: The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical method, considered the gold standard for drug confirmation in urine. No human experts are explicitly mentioned for establishing the ground truth in these studies, as the LC/MS directly provides it. The "three laboratory assistants" who ran the devices are operators, not ground truth experts.

• Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth for these studies was established by LC/MS to confirm the drug concentrations in the spiked urine samples.

4. Adjudication Method for the Test Set

• Precision Studies: Not explicitly stated, however, the results were quantified as positive/negative based on the criteria for each concentration and then tabulated. No formal adjudication process among multiple readers is described for the precision data, as the device's output (presence/absence of line) is objectively recorded.

• Method Comparison Studies: Three "laboratory assistants" viewed the device results, and their readings were compared against the LC/MS ground truth. There is no mention of an adjudication process (e.g., 2+1, 3+1) among these three assistants. Each viewer's discordant results were individually reported.

• Lay-user Study: The results from each lay person were recorded (positive/negative) and then compared to the known LC/MS-confirmed concentration of the sample. No adjudication among lay users is mentioned.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a rapid, qualitative drug test cup, which provides a direct visual result (lines appearing/not appearing). It does not involve AI assistance, nor does it involve human readers interpreting complex images or data that AI would augment. Therefore, there's no discussion of human readers improving with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, in the context of the device's output. The "Precision" studies and the "Interference," "Specificity," and "Effect of Urine Specific Gravity and pH" studies represent the standalone performance of the device itself to detect the analytes, as the results are based on the chemical reactions within the cup. The "Method Comparison" study also evaluates the standalone performance of the device's reading mechanism when interpreted by professional users, directly comparing it to the LC/MS reference.

7. The Type of Ground Truth Used

• The primary ground truth used across all analytical and clinical (in-house) studies was LC/MS (Liquid Chromatography-Mass Spectrometry). For the precision, interference, specificity, and pH/SG studies, the samples were spiked with known concentrations confirmed by LC/MS. For the method comparison study, unaltered clinical samples were directly compared against LC/MS results.

8. The Sample Size for the Training Set

• This device is a lateral flow immunochromatographic assay, not an AI/machine learning model. Therefore, there is no concept of a "training set" in the traditional sense for an algorithm. The development and optimization of the test's chemical components and cutoff concentrations implicitly involve internal R&D and calibration, but this is distinct from training an AI model on a dataset.

9. How the Ground Truth for the Training Set was Established

• As stated above, this is not applicable as it's not an AI/machine learning device requiring a training set. The "ground truth" for establishing the device's analytical performance (e.g., cutoff levels, cross-reactivity) would have been determined through empirical testing and comparison against established analytical methods like LC/MS during the device's development and validation.

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