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Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL.

Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL.

The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use.

The tests provide only a preliminary result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 20 ng/mL. The tests can be performed without the use of an instrument.

Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 50 ng/mL. The tests can be performed without the use of an instrument.

Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

This document describes the performance of the Rapid Marijuana (THC) Test Strip and Dipcard devices, available in 20 ng/mL and 50 ng/mL cutoff concentrations, for the qualitative detection of Marijuana and its metabolites in human urine.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity, specificity, or agreement percentages for accuracy studies). However, the performance data presented implies a standard of acceptable qualitative detection around the cutoff concentration. The precision and accuracy studies evaluate the device's ability to correctly identify positive and negative samples at various concentrations relative to the cutoff. The home-use study assesses user comprehension and ease of use.

Since no explicit numerical acceptance criteria are provided, I will present key performance indicators from the precision and accuracy studies. For the purpose of this table, I will infer that a high percentage of correct classifications at and around the cutoff, along with 100% correct classification for samples significantly above or below the cutoff, would be considered acceptable.

Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 20 ng/mL:

• Neg. (drug free): 27 Negative
• Neg. (+50% cutoff): 31 Positive | Site 1,2,3 (Agreement with LC/MS categories):
• Neg. (drug free): 27 Negative
• Neg. (+50% cutoff): 31 Positive |
  | Home Use Consumer Study | Agreement at 0 ng/mL: 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -50% Cutoff (10 ng/mL): 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -25% Cutoff (15 ng/mL): High percentage of Negative (e.g.,>90%) | 93% Agreement (2 Positive, 28 Negative) | 90% Agreement (3 Positive, 27 Negative) |
  | | Agreement at +25% Cutoff (25 ng/mL): High percentage of Positive (e.g.,>90%) | 90% Agreement (27 Positive, 3 Negative) | 93% Agreement (28 Positive, 2 Negative) |
  | | Agreement at +50% Cutoff (30 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |
  | | Agreement at +100% Cutoff (40 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |

Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 50 ng/mL:

• Neg. (drug free): 21 Negative
• Neg. (+50% cutoff): 30 Positive | Site 1,2,3 (Agreement with LC/MS categories):
• Neg. (drug free): 21 Negative
• Neg. (+50% cutoff): 30 Positive |
  | Home Use Consumer Study | Agreement at 0 ng/mL: 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -50% Cutoff (25 ng/mL): 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
  | | Agreement at -25% Cutoff (37.5 ng/mL): High percentage of Negative (e.g.,>90%) | 97% Agreement (1 Positive, 29 Negative) | 93% Agreement (2 Positive, 28 Negative) |
  | | Agreement at +25% Cutoff (62.5 ng/mL): High percentage of Positive (e.g.,>90%) | 93% Agreement (28 Positive, 2 Negative) | 93% Agreement (28 Positive, 2 Negative) |
  | | Agreement at +50% Cutoff (75 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |
  | | Agreement at +100% Cutoff (100 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |

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

• Precision Study:
  • Sample Size: For each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50), 3 lots were tested. Each lot involved 60 determinations for each of 9 concentration levels, across 6 operators at 3 Point-of-Care sites over 10 non-consecutive days. This totals to 1620 observations per device type in the precision study.
  • Data Provenance: The document does not explicitly state the country of origin for the urine samples. The study involved spiking drug-free urine specimens. The study itself was conducted at 3 Point-of-Care sites, but their locations are not specified. It is a prospective study as samples were prepared and tested specifically for this evaluation.
• Accuracy Study:
  • Sample Size: 80 clinical urine specimens were used for each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50) and each operator site. Since there were 3 operator sites, this amounts to 80 * 3 = 240 tests (device results vs. LC/MS) for each specificity (20 ng/mL and 50 ng/mL).
  • Data Provenance: The samples were described as "clinical urine specimens," implying they were collected from human subjects. The country of origin is not specified, and it's unclear if they were retrospective or prospectively collected for the study.
• Home Use Consumer Study:
  • Sample Size: 180 lay users participated in the study. Each user performed 1 test on a provided specimen. The samples were prepared for the study. For each device type and concentration category, 30 determinations were made.
  • Data Provenance: The document does not specify the country of origin of the lay users or the urine samples used. It is a prospective study.

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

• Precision Study: The ground truth for the spiked samples was established by the precise concentration of "-)-11-nor-9-Carboxy-Δ⁹-THC" added to drug-free urine, confirmed with LC/MS. No human experts were involved in establishing this ground truth, as it was based on laboratory preparation and analytical confirmation.
• Accuracy Study: The ground truth for the clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry). LC/MS is described as the "preferred confirmatory method." LC/MS is an analytical chemistry technique, not a human expert. Therefore, no human experts directly established the ground truth in this study; it was based on objective analytical measurement.
• Home Use Consumer Study: Similar to the precision study, the ground truth for samples was established by spiking drugs into urine with concentrations confirmed by LC/MS. No human experts were involved in establishing this ground truth.

4. Adjudication Method for the Test Set

• Precision Study: The results were read by operators comparing the test line intensity to the control line. There is no mention of an adjudication process for discrepancies in reading within the precision study; each determination (positive/negative) was recorded independently.
• Accuracy Study: The device results were compared directly to the LC/MS results. Discordant results are noted in tables (e.g., device positive when LC/MS was negative below cutoff, or device negative when LC/MS was positive above cutoff), but no formal adjudication method (like 2+1 reading) is described beyond this direct comparison.
• Home Use Consumer Study: The "Layer user Results" likely represent the interpretation of the test by the lay users themselves. No specific adjudication method 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

There was no MRMC comparative effectiveness study done. The device is a rapid, screening immunoassay test (similar to a pregnancy test) for qualitative detection of THC metabolites in urine, designed for Over-The-Counter use. It is interpreted visually by the user or an operator. There is no AI component in this device, nor is there a comparison of human readers with vs. without AI assistance.

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

This is not applicable as the device is a lateral flow immunochromatographic assay requiring human visual interpretation. It is not an algorithm-only device. The results are read visually.

7. The Type of Ground Truth Used

• Cross-reactivity and Interference Studies: Ground truth was established by precisely preparing samples with known concentrations of various compounds and expected drug-free or drug-spiked urine.
• Precision Study: Ground truth for the concentration levels of (-)-11-nor-9-Carboxy-Δ⁹-THC was confirmed using LC/MS.
• Accuracy Study: Ground truth for clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry).
• Home Use Consumer Study: Ground truth for the spiked samples was confirmed using LC/MS.

In summary, the primary ground truth method for quantitative confirmation of drug concentrations in samples was LC/MS.

8. The Sample Size for the Training Set

This information is not applicable to this device. As a rapid, screening immunoassay test, it does not involve machine learning or AI models that require a "training set." Its performance is based on the chemical reactions and visual detection inherent in the lateral flow assay.

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

This is not applicable as there is no training set for this device type.

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The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.

The provided text describes the 510(k) summary for the LYHER® Urine Multi-Drug Test Kits, which are rapid lateral flow immunoassays for the qualitative detection of several drugs in human urine. The study presented is a method comparison study to demonstrate substantial equivalence to a predicate device, not a study to establish acceptance criteria for a new AI/ML device. Therefore, much of the requested information (e.g., AI/ML specific details, number of experts, adjudication methods, MRMC study, sample size for training set) is not applicable or directly available from this document because it pertains to a different type of device and study.

However, based on the provided text, I can extract information related to the acceptance criteria (cut-off values) and the performance of the device in relation to these criteria.

1. Table of acceptance criteria and the reported device performance:

The acceptance criteria for these devices are defined by the cut-off concentrations for each drug. The reported device performance is demonstrated through in-house method comparison studies using various concentrations around these cut-offs. The precision studies indicate that samples at or below -25% of the cut-off were consistently negative, and samples at or above +25% of the cut-off were consistently positive. The method comparison tables provide more detailed performance around the cut-off by showing the number of positive and negative results at different concentration ranges compared to LC/MS results.

Here is a summary table, combining the listed cut-off values and inferring the performance based on the precision study description:

Note: The precision study states that "The test results of the specimens at the concentrations at and below -25% of the cut off obtained by all the three personnel were all negative while the test results of the specimens at the concentration at and above +25% of the cut off value were all positive." This broadly defines the performance against the cut-off. The method comparison tables offer more granular data but are too extensive to fully replicate here for each drug and each device type. These tables show that most results within the -25% to +25% cut-off range are discordant (either positive by LC/MS and negative by device, or vice-versa), which is expected for qualitative tests around the cut-off.

2. Sample size used for the test set and the data provenance:

• Sample Size for Precision Studies: For each drug and each concentration (-100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% cut off), 50 replicates were analyzed by each of 6 operators using three lots of the product. This means for one drug and one concentration, there were 50 replicates * 3 lots * 6 operators = 900 tests. Across 8 concentrations, this would be 7,200 tests per drug. Since there are 6 drugs, the total number of tests in the precision study is substantial.
• Sample Size for Method Comparison Studies:
  • AMP Cassettes, Dipcards, Cups: 43 negative urine samples, and a varying number of samples at different concentrations relative to the cut-off (e.g., for AMP Cassettes, 12 samples in -50% cut offcut off, 23 samples in Cut off+50%cut off, 17 samples >+50%cut off). The total number of unique samples is not explicitly stated but can be inferred by summing up the categories for each operator. For AMP Cassettes, for Operator 1, this totals 43 (negative) + 12 (+25%) + 17 (>+25%) = 95 unique samples. This was done for 3 operators for each of the 3 device types (cassette, dipcard, cup).
  • Similar sample distributions are provided for COC, MET, OPI, PCP, and THC across the cassette, dipcard, and cup formats.
• Data Provenance: The method comparison studies were performed "in-house" and used "unaltered clinical samples." The document does not specify the country of origin of the data, but the submitter is Hangzhou Laihe Biotech Co., Ltd., China. The studies are assumed to be retrospective as they involve "unaltered clinical samples" compared to a reference method.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is an in-vitro diagnostic test. "Experts" in the context of IVD performance usually refer to the highly accurate reference method. In this case:

• Ground Truth Method: Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are preferred confirmatory methods, and LC/MS was used to confirm drug concentrations in the precision studies and as the comparator (ground truth) in the method comparison studies.
• Number/Qualifications of Experts: The document does not refer to human experts establishing ground truth for individual samples, but rather mentions "three laboratory assistants" who "ran samples" for the method comparison studies and "6 operators" for the precision studies. These personnel are performing the tests, not establishing the ground truth. The ground truth is established by chemical analysis (LC/MS).

4. Adjudication method for the test set:

This information is not applicable as the device is an in-vitro diagnostic test and the ground truth is established by a quantitative chemical analysis (LC/MS), not through human expert consensus or qualitative review that would require adjudication.

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:

This is not applicable. The device is a rapid lateral flow immunoassay, not an AI/ML powered device, and no human reader assistance is involved in the interpretation beyond visual reading of the test lines. Therefore, an MRMC study related to AI assistance is not relevant.

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

This is not applicable. The device is not an algorithm or AI system. It is a physical immunoassay kit.

7. The type of ground truth used:

The ground truth used for establishing performance and comparing results in the method comparison study is LC/MS (Liquid Chromatography / Mass Spectrometry), which is a highly accurate chemical method for quantifying drug concentrations in urine.

8. The sample size for the training set:

This is not applicable as the device is not an AI/ML system and does not have a "training set" in that context. The device's performance is inherently based on its biochemical design.

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

This is not applicable for the same reason as above. If considering the "training" analogous to R&D and optimization of the immunoassay, the performance characteristics (e.g., specificity, cross-reactivity) would have been established using controlled spiking experiments and comparison to reference methods like LC/MS. The document mentions "These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS" in the precision studies, which indicates how known concentrations were established for performance evaluation.

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The Healgen® Accurate Oral Fluid Drug Test COT is a lateral flow chromatographic immunoassay for the qualitative detection of COT in oral fluid at the cut-off concentration 30 ng/mL.

This assay provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test.

The Healgen® Accurate Oral Fluid Drug Test is a competitive binding lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid at the cutoff concentrations listed below and their metabolites.

This assay 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 spectrometry (GC/MS) and liquid chromatography mass spectrometry (LC/MS) are the preferred confirmatory methods.

The Healgen® Accurate Oral Fluid Drug Test COT is immunochromatographic assay that uses a lateral flow system for the qualitative detection of cotinine in human oral fluid. The Healeen® Accurate Oral Fluid Drug Test immunochromatographic assay for the qualitative and simultaneous detection of Marijuana (THC) and Cotinine in human oral fluid. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

This document describes the performance characteristics and studies for the Healgen® Accurate Oral Fluid Drug Test and Healgen® Accurate Oral Fluid Drug Test COT, which are qualitative immunoassays for detecting Cotinine (COT) and Marijuana (THC) in oral fluid.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. However, the "Precision-Reproducibility-Cut-Off" studies implicitly define the expected performance around the cut-off values. The "Comparison Studies" and "Layuser Studies" then demonstrate the agreement of the device with a gold standard (LC/MS/MS).

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

• Precision-Reproducibility-Cut-Off (Analytical Performance):

  • For each of the 9 concentration levels and 3 device lots: 50 samples (2 runs per day for 25 days).
  • Total samples = 9 concentrations * 50 samples/concentration * 3 lots = 1350 samples for COT, and 1350 samples for THC.
  • Data Provenance: Samples were "spiked" with cotinine or marijuana in negative oral fluid samples, indicating a controlled laboratory setting. The origin (country/retrospective/prospective) is not specified, but the nature of spiking implies prospective sample preparation for the study.

• Method Comparison Studies (Expert Operator):

  • COT: 427 samples
  • THC: 126 samples
  • Data Provenance: Oral fluid samples. The data provenance (e.g., country of origin, retrospective or prospective collection) is not specified.

• Layuser Studies:

  • COT: 362 samples
  • Data Provenance: Oral fluid samples. The data provenance is not specified.

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

• Ground Truth Establishment: The ground truth for all performance studies (Precision, Method Comparison, Layuser) was established by LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry), which is stated as the "preferred method confirmation test."
• Qualifications of Experts: This implies that the ground truth was not established by human experts interpreting images or subjective data, but by highly accurate analytical laboratory equipment and the qualified personnel operating it. The document does not specify the number or qualifications of the lab personnel who performed the LC/MS/MS analysis, as GC/MS and LC/MS/MS are considered an objective gold standard in drug testing.

4. Adjudication Method for the Test Set

• LC/MS/MS serves as the objective ground truth, providing quantitative results against which the device's qualitative results are compared. Therefore, an "adjudication method" in the sense of reconciling disagreements between human readers is not applicable here. Any discrepancies between the device result and LC/MS/MS are reported as "discordant results."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• This is not an AI-assisted diagnostic device, but a rapid diagnostic test (lateral flow immunoassay). Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable.
• The "Layuser Studies" evaluate the performance of the device in the hands of untrained users, essentially assessing human performance with the device instructions. It shows that layusers can achieve comparable results to expert operators for COT detection.

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

• This question is not applicable as the device is a lateral flow immunoassay kit, not an algorithm. Its "standalone" performance is inherently demonstrated by the results it produces directly from the oral fluid sample, without further human-in-the-loop interpretation beyond reading the visual lines on the strip. The "Precision-Reproducibility-Cut-Off" and "Method Comparison Studies" characterize this inherent device performance.

7. The Type of Ground Truth Used

• The ground truth used was analytical confirmation by LC/MS/MS. This is an objective, quantitative laboratory method considered the gold standard for drug detection and quantification in biological samples.

8. The Sample Size for the Training Set

• The document describes performance studies, but it does not mention a "training set" in the context of machine learning. This is a traditional immunoassay device, which does not employ machine learning algorithms that require separate training and test sets. The studies described are for analytical and clinical validation of the device's performance.

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

• As there is no mention of a "training set" for a machine learning model, this question is not applicable.

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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:

• 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.

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Clungene Methamphetamine Tests are immunochromatographic assays for the qualitative determination of dmethamphetamine in human urine at cut-off concentration of 1000 ng/mL. The calibrator is d-methamphetamine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-Nor-△9-Tetrahydrocannabinol-9-COOH in human urine at cut-off concentration of 50 ng/mL. The calibrator is 11-Nor-△9-Tetrahydrocannabinol-9-COOH. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. This test is intended for over-the-counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

Clungene Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The callbrator is Morphine. The tests are available in a Cassette format, a Easy Cup format, a Split Key Cup format and a Dip Card format. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. This test is intended for over the counter (OTC) consumer use as the first step in a two-step process to provide consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. For in vitro diagnostic use only.

The CLUNGENE Methamphetamine Tests, CLUNGENE Morphine Tests, and CLUNGENE Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Here's a breakdown of the acceptance criteria and study information for the Clungene Methamphetamine, Morphine, and Marijuana Tests, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for accuracy, sensitivity, or specificity that the device must meet for approval. Instead, it describes performance characteristics and then presents the results of those studies. The implicit acceptance criteria appear to be the demonstrated performance of the device showing appropriate qualitative detection relative to the cut-off concentrations when compared to GC/MS, and user readability for OTC use.

Performance Characteristics Summary (Implicit Acceptance Criteria and Reported Performance)

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

• Professional User (Method Comparison) Test Set:
  • Sample Size: 80 unaltered clinical urine samples per drug (40 negative, 40 positive).
  • Data Provenance: Retrospective, described as "in-house" studies using "unaltered clinical samples." The country of origin is not explicitly stated, but the manufacturer is based in China.
• Lay-user Study Test Set:
  • Sample Size:
    • Participants: 1680 lay persons.
    • Samples: 1 device per participant, with one blind-labeled urine sample.
    • For each drug (Methamphetamine, Morphine, Marijuana) and each device format (Cassette, Dip Card, Split-Key Cup, Easy Cup), there were a total of 7 concentrations tested. For each concentration, 20 samples were used.
    • Total samples per drug (e.g., Methamphetamine): 7 concentrations * 20 samples/concentration = 140 samples.
    • Total samples for all 3 drugs across all 4 device formats: 3 drugs * 4 device formats * (7 concentrations * 20 samples/concentration) = 3 * 4 * 140 = 1680 samples. This matches the number of lay persons, implying each lay person tested one sample with one device.
  • Data Provenance: Prospective, as it involved lay persons testing samples. The study was performed "at three intended user sites," but the country of origin for these sites is not specified. Samples were prepared by spiking known drug concentrations into drug-free pooled urine.

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

• Professional User (Method Comparison) Test Set:
  • Number of "Experts": Three "laboratory assistants" were involved in running the visual tests for comparison. Their qualifications are not specified beyond being "laboratory assistants."
  • Ground Truth: The ground truth for the clinical samples was established by Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the gold standard for drug quantification.
• Lay-user Study Test Set:
  • Number of Experts: No explicit "experts" were used to establish the ground truth for reading the device results in this specific study, as the lay users were the test subjects. The ground truth for the sample concentrations was established by GC/MS.

4. Adjudication Method for the Test Set

• Professional User (Method Comparison) Test Set: No formal adjudication method (like 2+1 or 3+1) is described for the visual interpretation by the three laboratory assistants. Each assistant's interpretation was recorded and compared to the GC/MS ground truth. Discordant results between the device and GC/MS were tabulated for each viewer individually.
• Lay-user Study Test Set: No adjudication. Each lay user read their own device result.

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 such MRMC comparative effectiveness study was done. The device is a qualitative immunochromatographic assay for drug detection, not an AI interpretation system.

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

This is not applicable as the device is a manual, visually interpreted immunochromatographic assay, not an algorithm or AI system. Its performance is inherently "standalone" in that it produces a visual result without external algorithm assistance for interpretation, but it always requires human observation and interpretation.

7. The Type of Ground Truth Used

• For all studies (Precision, Cut-off, Specificity, Interference, Method Comparison, Lay-user): The primary ground truth for the presence and concentration of drugs in urine samples was Gas Chromatography/Mass Spectrometry (GC/MS). This is considered a highly accurate and quantitative analytical method.

8. The Sample Size for the Training Set

This information is not provided. The document describes performance testing of the finished device. For immunochromatographic assays, there isn't typically a "training set" in the machine learning sense. Instead, development involves R&D to optimize reagents, membrane materials, and assay parameters. The performance studies described serve to validate the finalized design.

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

Not applicable, as a "training set" in the AI sense is not relevant for this type of device. During the development and optimization of the assay, standard reference materials of known drug concentrations (confirmed by methods like GC/MS) would be used to evaluate and refine the test's linearity, sensitivity, and specificity.

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EGENS Urine Test Cup THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL respectively. EGENS Urine Test Cup THC-MDMA test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. CCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test DipCard THC-MDMA is a rapid test for the qualitative detection of Cannabinoids and Methylenedioxymethamphetamine in human urine at a cutoff concentration of 50 ng/mL and 500 ng/mL, respectively. EGENS Urine Test DipCard THC-MDMA 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test Cassette Marijuana is a rapid test for the qualitative detection of Cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

EGENS Urine Test Cassette Marijuana test provides only preliminary test results. A more specific alternative chemial method must be used in order to obtain a confirmed analytical result. CC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

EGENS Urine Test MDMA uses immunochromatographic assays for Methylenedioxymethamphetamine. These tests are lateral flow systems for the qualitative detection of Methylenedioxymethamphetamine in human urine. EGENS Urine Test Marijuana (THC) uses immunochromatographic assays for Cannabinoids. These tests are lateral flow systems for the qualitative detection of Cannabinoids in human urine. Each test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

This document describes the performance of the EGENS Urine Test Marijuana (THC) and EGENS Urine Test MDMA devices. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by their performance around the cutoff concentrations. For instance, samples significantly below the cutoff should test negative, and samples significantly above should test positive, with the most variability expected around the cutoff. The reported performance is based on precision studies and lay-user studies.

Precision Study Performance (Examples from THC DipCard and MDMA DipCard):

Lay-User Study Performance (Examples from THC Cassette and MDMA DipCard):

The acceptance criteria are generally that the device correctly identifies negative samples as negative and positive samples as positive, with some allowance for variability around the cutoff concentration. The high agreement percentages for samples significantly away from the cutoff (100% for -100%, -75%, -50% and +50%, +75%) demonstrate the device meets these criteria. The variability around the -25% and +25% cut-off points is expected for qualitative tests designed to provide a preliminary result.

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

• Precision Studies: For each concentration level (-100%, -75%, -50%, -25%, at cut-off, +25%, +75%, +100% cut-off) and for each of the three lots, tests were performed two runs per day by three operators for 25 days.
  • Total tests per concentration per lot: 2 runs/day * 3 operators = 6 tests per day. Over 25 days, this is 6 * 25 = 150 tests per concentration per lot. The results shown for each lot represent 50 tests (-/+) which implies 50 individual sample aliquots were tested (likely 1 aliquot per operator per day over some period, or 2 aliquots per day for 25 days by one operator per lot, etc., but the interpretation from the table is 50 results per lot per concentration).
  • Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing (in-house). The document does not specify the country of origin for the samples themselves. These samples were prepared by spiking known concentrations into urine.
• Method Comparison Studies (Clinical Samples):
  • Sample Size: 80 "unaltered clinical samples" for Cannabinoids (40 negative and 40 positive) for each format (DipCard, Cup, Cassette). 80 "unaltered clinical samples" for MDMA (40 negative and 40 positive) for each format (DipCard, Cup).
  • Data Provenance: "in-house" (presumably for testing execution). The origin of the "unaltered clinical samples" is not specified (e.g., country of origin, retrospective/prospective collection).
• Lay-user Study:
  • Sample Size: 700 lay persons in total.
    • 100 tested for drug-free samples only.
    • 360 for Cannabinoids samples only.
    • 240 for Methylenedioxymethamphetamine samples only.
  • Each participant was given 1 blind-labeled sample.
  • For each drug and concentration level shown in the tables (e.g., Cannabinoids -100%, -75% etc.), 20 samples were tested.
  • Data Provenance: Not explicitly stated beyond "performed at three intended user sites." The origin of the urine specimens (drug-free pooled urine spiked with drugs) is consistent with controlled laboratory preparation.

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

• For Precision, Cut-off, Interference, and Specificity Studies: The ground truth was established by preparing urine samples with known, spiked concentrations of the analytes. No human experts were used for this ground truth creation.
• For Method Comparison Studies (Clinical Samples): The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly accurate and generally accepted confirmatory method for drug testing. No human experts were involved in establishing this ground truth, as it is an analytical chemical method.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, and Specificity Studies: Ground truth was based on spiked concentrations. Discrepancies between expected results and device results were noted and analyzed, but no adjudication by human experts was described as the samples had known concentrations.
• Method Comparison Studies (Clinical Samples): The device results were compared directly to the GC/MS results. Discordant results are presented, but there is no mention of an adjudication process (e.g., by experts) to resolve these discrepancies in the context of the study's conclusions. GC/MS results are generally considered the gold standard for confirmation.
• Lay-user Study: The ground truth was established by GC/MS for the spiked samples. The lay-users' interpretations of the device results were compared to these GC/MS confirmed concentrations.

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 performed.
• These devices are qualitative urine drug screening tests for direct visual interpretation. They are not AI-assisted imaging or diagnostic devices that would typically involve human readers interpreting complex images with or without AI assistance. The "Viewers" mentioned in the method comparison study are likely laboratory assistants reading the test strips, and their role is to interpret the visual lines on the test, not to make complex diagnostic decisions.

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

• Yes, a standalone performance was done for the device itself. The device itself is a standalone, rapid immunoassay that produces a visual result inherently. There is no separate "algorithm" being evaluated beyond the chemical assay's performance.
• The "Precision" studies and "Cut-off" studies directly demonstrate the device's performance in detecting specific concentrations without human interpretation variability influencing the reported percentage agreements at extreme concentrations.
• The "Method Comparison Studies" compare the device's visual output (as interpreted by "Viewers") directly against GC/MS. This is a measure of the device's accuracy in producing a result that then is read.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Spiked Samples (for Precision, Cut-off, Interference, Specificity, and Lay-user Studies): Known concentrations of target analytes (Cannabinoids, MDMA) added to urine. This is a highly controlled laboratory method to establish ground truth.
• Gas Chromatography/Mass Spectrometry (GC/MS) (for Method Comparison Studies and confirmation for Lay-user Study samples): This is an advanced analytical chemical method, considered a gold standard for confirming the presence and concentration of drugs in urine.

8. The Sample Size for the Training Set

• Not applicable. These are lateral flow immunochromatographic assays, not machine learning or AI models with "training sets." The device's performance is based on its chemical and biological components, which are designed and manufactured, not "trained" in the computational sense.

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

• Not applicable, as there is no training set for this type of device.

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The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against 11-nor-9-carboxy-A9-THC (cTHC). This in-vitro device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.

The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis cTHC Urine Control Set: The Immunalysis cTHC Urine Control Set is used as control materials in the Immunalysis Cannabinoids Urine Enzyme Immunoassay.

Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal and polyclonal antibodies to Cannabinoids, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Cannabinoids derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use.

All of the Immunalysis cTHC Urine Calibrators and Controls are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.

The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control and HIGH Control are prepared by spiking known concentrations of 11-nor-9-carboxy-Δ'-THC (cTHC) into the negative calibrator matrix. The negative calibrator, Level 1 calibrator, Level 2 calibrator, Level 3 calibrator, Level 4 calibrator and two controls are sold as individual bottles.

The document describes the Immunalysis Cannabinoids Urine Enzyme Immunoassay, its calibrators, and control set, which are intended for qualitative and semi-quantitative analysis of Cannabinoids in human urine with a cutoff of 50ng/mL. The study evaluates the performance of the device against this cutoff.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document for each test. However, the studies demonstrate the device's performance relative to its intended use and consistency around the 50 ng/mL cutoff. The implicit acceptance criteria appear to be:

• Qualitative Analysis: Accurate classification of samples as negative below the -25% cutoff and positive above the +25% cutoff, with consistent results at the cutoff.
• Semi-Qualitative Analysis: Similar to qualitative, with consistent results around the cutoff.
• Specificity and Cross-Reactivity: Structurally similar compounds should show expected cross-reactivity, and structurally dissimilar compounds should not interfere.
• Interference: Various endogenous compounds, pH levels, and specific gravity should not cause interference.
• Recovery: Expected concentrations should be recovered within an acceptable range.
• Method Comparison: High agreement with LC/MS confirmation for both qualitative and semi-quantitative modes.
• Calibration and Control Performance: Traceability and stability of calibrators and controls within specifications.

• Samples at 0, 12.5, 25, 37.5 ng/ml (cutoffs -100% to -25%) showed 80 Negative results (100% agreement).
• Samples at 50 ng/ml (cutoff) showed 40 Negative/40 Positive results.
• Samples at 62.5, 75, 87.5, 100 ng/ml (cutoffs +25% to +100%) showed 80 Positive results (100% agreement). |
  | Semi-Quantitative Analysis (50ng/mL cutoff)| Similar to qualitative analysis. | Table 3:
• Samples at 0, 12.5, 25, 37.5 ng/ml showed 80 Negative results (100% agreement).
• Samples at 50 ng/ml (cutoff) showed 38 Negative/42 Positive results.
• Samples at 62.5, 75, 87.5, 100 ng/ml showed 80 Positive results (100% agreement). |
  | Specificity & Cross-Reactivity (Structurally Related Compounds - Qualitative)| Expected varying cross-reactivity for structurally similar compounds at specific concentrations. | Table 4:
• 11-nor-9-carboxy-Δ9-THC (50ng/mL): 100% Cross-Reactivity (Positive)
• (±) 11-Hydroxy-Δ9-THC (100ng/mL): 50.0% Cross-Reactivity (Positive)
• 11-nor-Δ8-carboxy-THC (40ng/mL): 125.0% Cross-Reactivity (Positive)
• Cannabinol (75ng/mL): 66.7% Cross-Reactivity (Positive)
• Cannabidiol (1,000,000ng/mL):

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The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Cannabinoids in neat human oral fluid, collected into the LZI Oral Fluid THC Collector, at the cut-off value of 4 ng/mL with △9- tetrahydrocannabinol (THC) as calibrators. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Oral Fluid Cannabinoids Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL.

The LZI Oral Fluid Cannabinoids Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL.

The LZI Oral Fluid Cannabinoids assay is a homogeneous enzyme immunoassay with ready-touse liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cannabinoid derivative-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound cannabinoid derivative-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

The Ri solution contains mouse monoclonal anti-Cannabinoids antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with Cannabinoids, stabilizers, in buffer with sodium azide (0.09%) as preservative.

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay calibrators and controls designated for use at the 4 ng/mL cutoffs contain 0, 2, 3, 4, 5, 6, and 12 ng/mL of Δ'-tetrahydrocannabinol (THC) in synthetic oral fluid with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.

The provided text describes the LZI Oral Fluid Cannabinoids Enzyme Immunoassay, its acceptance criteria, and the studies performed to demonstrate its performance.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section. However, the performance characteristics provided, particularly the "Method Comparison: Clinical Samples" and "Precision" data, implicitly define the expected performance for qualitative and semi-quantitative results against a confirmatory method (GC/MS).

Given the information, the acceptance criteria can be inferred as a high concordance between the immunoassay and the GC/MS reference method, especially for distinguishing between positive and negative samples around the 4 ng/mL cutoff. For specific values, the "Precision" tables show the expected ranges of positive/negative results at various concentrations relative to the cutoff.

Here's a table summarizing the reported device performance, inferring acceptance based on achieving high concordance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 42 positive and 41 negative unaltered oral fluid samples, totaling 83 samples.
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective as samples were collected and then evaluated. The samples were collected using the "LZI Oral Fluid Collector."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The ground truth was established by Gas or Liquid Chromatography/mass spectrometry (GC/MS or LC/MS), which is described as the "preferred confirmatory method." This is a laboratory analytical technique, not a human expert judgment. Therefore, the concept of "number of experts" is not applicable in this context.

4. Adjudication method for the test set:

• No adjudication method involving human experts is described since the ground truth was established by GC/MS. The immunoassay results were directly compared to the GC/MS quantitative values.

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 device is an in-vitro diagnostic (IVD) assay for drug detection, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results.

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

• Yes, a standalone performance study was done. The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is an automated assay designed for use with clinical chemistry analyzers (e.g., Beckman AU400e). Its performance (precision, method comparison) was evaluated directly as the algorithm/assay only, without human interpretation factored into the core performance metrics presented. While a human might interpret the final positive/negative result, the performance data itself is of the device in isolation.

7. The type of ground truth used:

• The ground truth used was analytical confirmation by Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly specific and sensitive laboratory method considered the "gold standard" for confirming drug presence and concentration.

8. The sample size for the training set:

• The document does not provide information on a training set size. The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is a chemical assay (enzyme immunoassay), not a machine learning or AI algorithm that typically requires a distinct training dataset. Its development would involve chemical optimization and characterization rather than algorithm training.

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

• As there's no explicit mention of a training set in the context of an AI/ML algorithm, this question is not applicable in the same way it would be for an AI device. The "ground truth" for developing such an assay would involve known concentrations of target analytes and cross-reactants to characterize the assay's chemical behavior.

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FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split Cup format. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split Cup format. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow system for the qualitative detection of 11-nor-A9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

This document describes the performance characteristics of the FaStep Marijuana Tests and FaStep Methamphetamine Tests. These are immunochromatographic assays for the qualitative determination of 11-nor-Δ9-THC-9-COOH (Marijuana metabolite) and Methamphetamine in human urine, manufactured by POLYMED THERAPEUTICS, INC. The document presents data to demonstrate that the devices meet acceptance criteria for precision, cut-off verification, interference, specificity, and comparison with a reference method (GC/MS).

Here's a breakdown of the requested information, adapted from the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance of the device in various studies. The core acceptance is accurate qualitative determination (positive/negative) at specific cut-off concentrations, with high correct result percentages and low rates of false positives/negatives, especially near the cut-off.

Overall Performance Summary (Inferred Acceptance Criteria vs. Reported Performance):

MET: 3,4-Methylenedioxymethamphetamine (MDMA) showed high cross-reactivity (200%), which is physiologically relevant for methamphetamine testing. Other compounds showed lower cross-reactivity (e.g., L-Methamphetamine at 10%, Ephedrine at 25%) or were not detected (D-Amphetamine). "No differences observed for different formats." |
| Comparison Studies (Clinical Samples) | High agreement with GC/MS results, particularly for samples near the cut-off, demonstrating clinical validity. Minimal discordant results. | For both THC and MET tests across all formats, 80 clinical samples (40 negative, 40 positive) were tested. The tables show a high concordance with GC/MS results. Discordant results primarily occurred for samples very close to the cut-off concentration, either false positives slightly below cut-off or false negatives slightly above cut-off (e.g., 1-2 discordant results per viewer for THC and MET strip format, typically within 25% of the cut-off). Overall high agreement was demonstrated. |
| Lay-User Study | High percentage of correct interpretations by lay users, and clear, easy-to-understand instructions. | Across all formats (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) for both THC and MET, lay users achieved 100% correct results for samples at -100%, -75%, -50% cut-off (negative) and +25%, +50%, +75% cut-off (positive). For samples at -25% cut-off, correct results ranged from 90.2% to 95.2% (some false positives). For samples at +25% cut-off, THC tests showed 100% correct results, while MET tests showed 95.2% to 100% depending on the format. All lay users indicated that the device instructions were easily followed (Flesch-Kincaid Grade Level 7). |

2. Sample Size and Data Provenance

• Precision Studies:

  • Sample Size: For each drug (THC, MET), each concentration level (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100% cut-off), across 3 different lots of the device, 50 tests were performed (2 runs per day for 25 days). This means for each drug and each format, 9 concentrations x 3 lots x 50 tests = 1350 data points per format were generated for precision, although only summarized frequency counts are provided.
  • Data Provenance: Not explicitly stated, but implied to be laboratory-controlled samples prepared by spiking drugs into negative samples. The concentration was confirmed by GC/MS. This suggests a retrospective controlled laboratory study, likely conducted in the US (given the FDA submission).

• Cut-off Verification:

  • Sample Size: 150 samples equally distributed at concentrations of -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off. These were tested using three different lots of each device.
  • Data Provenance: Laboratory-controlled spiked samples.

• Interference & Specificity:

  • Sample Size: Concentrations of various compounds were tested in drug-free urine and in urine containing target drugs at 25% below and 25% above the cut-off. Tested using three batches (lots) of each device for all formats.
  • Data Provenance: Laboratory-controlled spiked samples.

• Comparison Studies (Clinical Samples):

  • Sample Size: 80 unaltered clinical samples per drug (40 negative and 40 positive, categorized based on GC/MS). These samples were used for each of the four device formats (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup).
  • Data Provenance: "In-house with three laboratory assistants." Samples were "unaltered clinical samples." The country of origin is not specified but is implicitly the US for an FDA submission. This was a retrospective study using existing clinical samples.

• Lay-User Study:

  • Sample Size: 147 lay persons. Urine samples were prepared at 7 concentration levels (negative, +/- 75%, +/- 50%, +/- 25% of the cut-off). Each participant was provided with 1 blind-labeled sample (implying each individual participant tested one sample concentration per drug type and format, making the overall sample count for analysis 21 samples per concentration level per drug type - 7 concentrations x 21 participants = 147 tests. Since both THC and MET were tested per participant per format, this would be 147 x 2 = 294 tests per format (or total if formats were varied).
  • Data Provenance: "Performed at three intended user sites." Controlled spiked samples, blind-labeled. This was a prospective study with lay users.

3. Number of Experts and Qualifications for Ground Truth

• Expert Establishment of Ground Truth: The ground truth for all analytical and clinical comparison studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted "gold standard" method for confirming drug concentrations in urine.
• Qualifications of Experts: The document does not specify the number or detailed qualifications of the individuals who performed the GC/MS analysis (e.g., "radiologist with 10 years of experience"). However, GC/MS is a laboratory analytical method, and it is assumed that the personnel operating such sophisticated equipment are qualified laboratory technicians/scientists with appropriate training and experience in analytical chemistry. For the comparison studies, three laboratory assistants performed the device readings. Their specific qualifications beyond "laboratory assistants" are not detailed.

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1, 3+1) is explicitly described for the individual readings of the rapid tests in the comparison studies.
• For the comparison studies, three laboratory assistants ("Viewers A, B, C") independently read the results of the 80 clinical samples for each device format. Their individual readings were then compared against the GC/MS ground truth. The discordant results are individually listed for each viewer against the GC/MS result. This implies independent assessment rather than a consensus or adjudication process among the viewers themselves for the final study result.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done regarding human readers improving with AI vs. without AI assistance.
  • This device is a rapid diagnostic test (lateral flow immunoassay) for drug screening, not an "AI-assisted" diagnostic imaging device (e.g., for radiology). Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable here.
  • The "human readers" in the comparison studies were laboratory assistants reading the strip/panel for a visible line, and lay users following instructions. There is no AI component involved in the interpretation of these tests according to the documentation provided.

6. Standalone (Algorithm Only) Performance

• Not applicable. As stated above, this is a chemical immunoassay, not an algorithm-only device. The test itself performs the "detection" by the presence or absence of a colored line, which is then interpreted by a human user. There is no software algorithm that provides a standalone diagnostic output without human involvement.

7. Type of Ground Truth Used

• The primary and definitive ground truth for all analytical and comparison studies was GC/MS (Gas Chromatography/Mass Spectrometry) results. GC/MS is a highly precise and accurate analytical method used to identify and quantify substances, making it a robust form of outcomes data or a highly regarded reference standard for determining the true concentration of drug metabolites in urine.

8. Sample Size for the Training Set

• Not applicable. This device is a biochemical immunoassay, not an AI/machine learning model that requires a "training set" of data. The manufacturing process and reagent formulations are established through traditional laboratory development and quality control, not through data-driven model training.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an AI/machine learning model, there is no ground truth to be established for such a set. The "ground truth" (i.e., known concentrations of analytes) used in the analytical performance studies (precision, cut-off, interference, specificity) was established by carefully prepared spiked samples with concentrations confirmed by GC/MS.

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Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 50 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Healgen mAMP One Step Methamphetamine Test is an immunochromatographic assay for the qualitative determination of methamphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

The provided document describes the performance characteristics of the Healgen THC One Step Marijuana Test and the Healgen mAMP One Step Methamphetamine Test, and concludes that they are substantially equivalent to a predicate device.

Here's an analysis of the acceptance criteria and the studies that support it:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by the results of the performance studies presented, primarily focused on their ability to correctly identify drug presence/absence at and around the specified cutoff concentrations. The studies demonstrate that for samples at or above +25% of the cutoff, the devices consistently show positive results, and for samples at or below -25% of the cutoff, they consistently show negative results. At the cutoff concentration, there is some variability, which is expected for qualitative tests.

Healgen THC One Step Marijuana Test (Cut-off: 50 ng/mL)

Healgen mAMP One Step Methamphetamine Test (Cut-off: 1000 ng/mL)

2. Sample Sizes and Data Provenance

• Precision Study: For each drug (THC and MET) and each format (Strip, Cassette, Cup, Dip Card), 8 concentrations (-100% cut off to +100% cut off) were tested. For each concentration, tests were performed two runs per day for 25 days. This implies 50 individual tests per concentration per lot, and 3 lots were used for each format.
  • Example for THC Strip: 8 concentrations x 50 tests/concentration x 3 lots = 1200 tests.
  • Data Provenance: The document does not explicitly state the country of origin but implies an in-house laboratory setting (referred to as "in-house" for comparison studies, and "prepared by spiking drug in negative samples" for precision, cut-off, and interference studies). The data is retrospective in the sense that samples were prepared and then tested. The urine samples were "negative samples" (for spiking) or "drug-free urine" (for interference), suggesting they were sourced specifically for testing purposes.
• Cut-off Verification Study: 150 samples were used, equally distributed at concentrations of -50%, -25%, Cut-Off, +25%, +50% Cut-Off. So, 30 samples per concentration.
  • Data Provenance: Similar to precision, prepared by spiking.
• Interference Study: Urine samples (drug-free and spiked with target drugs +/-25% Cut-Off) were used for testing various interfering substances. The number of samples per substance is not specified, but it was tested using three batches of each device for all formats.
  • Data Provenance: Assumed to be artificially created/spiked samples.
• Method Comparison Study: For each drug and each format, 80 unaltered clinical urine samples were used (40 negative, 40 positive).
  • Data Provenance: The samples are described as "clinical samples," suggesting real-world patient samples. The country of origin is not specified, but the study was performed "in-house." This is retrospective data.
• Lay-user Study: 140 lay persons participated. Urine samples were prepared at 7 different concentrations (negative, +/-75%, +/-50%, +25% of cutoff). For each concentration, 20 samples were prepared.
  • Data Provenance: Artificially prepared by spiking into drug-free pooled urine specimens.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH:
  • The ground truth for these analytical performance studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted gold standard method for quantifying drug concentrations in urine.
  • The document states that "Each drug concentration was confirmed by GC/MS" and that the "concentrations of the samples were confirmed by GC/MS." No human experts are explicitly mentioned for establishing ground truth from GC/MS results, as GC/MS is an objective analytical method.
• Method Comparison Study:
  • The ground truth for the 80 clinical samples was established by GC/MS results.
  • No specific number or qualifications of human experts are mentioned for interpreting the GC/MS results or establishing the ground truth from them.
• Lay-user Study:
  • Ground truth was established by GC/MS for the spiked urine samples.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH: For these analytical studies, GC/MS was the objective reference. The testing was done by unspecified personnel; "sample aliquots were blinded labeled by the person who prepared the samples and won't take part in the sample testing" (precision study). This suggests a blinding mechanism but no explicit multi-reader adjudication process for the actual device results.
• Method Comparison Study: Three laboratory assistants were the "operators" who ran the devices and presumably interpreted the results. The comparison was against GC/MS. The individual results of each viewer are reported, and then discordant results are listed. There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus among the three viewers) to arrive at a single device result per sample if their interpretations differed. Each viewer's interpretation is compared independently to the GC/MS ground truth.
• Lay-user Study: The study involved "140 lay persons" each testing "1 blind labeled sample and a device." The "Lay person results" table shows aggregate counts of positive/negative results. It does not describe an adjudication process for discordant interpretations among lay users on a single sample, as each lay user tested a unique sample (or set of samples for the overall study) and their individual interpretation was the data point.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was described. The studies focused on the performance of the device itself, observed by laboratory assistants (method comparison) or lay users (lay-user study), against an objective ground truth (GC/MS). There is no comparison of "human readers improve with AI vs without AI assistance" because the device is a simple, qualitative immunochromatographic assay, not an AI-powered diagnostic system requiring human interpretation of complex AI outputs.

6. Standalone Performance Study (Algorithm Only)

The device itself is a standalone, qualitative diagnostic test (immunochromatographic assay). All the performance studies (precision, cut-off, interference, specificity, method comparison, lay-user study) assess the standalone performance of the device without human interpretation being the primary variable. The "human-in-the-loop" component is essentially the reading and interpretation of the colored lines on the test strip as positive or negative, which is intrinsic to this type of device. There isn't an "algorithm" in the sense of a sophisticated computational model that could be evaluated separately from the physical test.

7. Type of Ground Truth Used

The primary and consistently used ground truth for all analytical and comparative studies was GC/MS (Gas Chromatography/Mass Spectrometry). This is an objective, highly accurate analytical method for drug concentration determination.

8. Sample Size for the Training Set

The document does not describe the development of an "algorithm" or "AI" system that would typically require a training set. This is an immunochromatographic assay, which relies on chemical and biological reactions rather than machine learning algorithms. Therefore, there is no "training set" in the context of AI. The product validation data described (precision, cut-off, interference, specificity, method comparison) serves to demonstrate the device's performance, not to "train" it.

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

As there is no "training set" in the context of AI/algorithm development for this device, this question is not applicable. The device's inherent design and manufacturing processes are validated by the performance studies using GC/MS as the ground truth.

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