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The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocanabinol in human oral fluid. 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 insted analytes in anycombination, up to a maximum of 6 analytes. The tests provide only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test 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® Oral fluid Multi-Drug Test Kit (Cube) is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The LYHER® Oral fluid Multi-Drug Test Kit (Cube) device consists of a cube device, an oral fluid collection swab and a package insert.

The document describes the analytical performance studies for the LYHER® Oral fluid Multi-Drug Test Kit (Cube), a rapid lateral flow immunoassay. The device is designed to detect d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine, and Delta-9-Tetrahydrocannabinol in human oral fluid.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" as a pass/fail threshold for performance, but rather presents the results of precision-reproducibility studies across various concentrations relative to the cut-off. The performance is summarized by the number of positive and negative results at each concentration.

To construct a table of "acceptance criteria" (inferred as target performance, though not explicitly defined as such) and reported performance, we can focus on the precision-reproducibility studies around the cut-off and the comparison study data. For the comparison study, the implicit acceptance criterion is that the device accurately identifies samples as positive or negative relative to the LC/MS confirmation.

Inferred Acceptance Criteria (Conceptual) and Reported Device Performance

Note on Acceptance Criteria: The document provides raw performance data. For a qualitative immunoassay, the "acceptance criteria" are usually demonstrated by a high rate of negativity well below the cutoff, a high rate of positivity well above the cutoff, and a predictable transition zone around the cutoff concentration. The data presented supports this.

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

• Test Set Sample Size:

  • Precision-Reproducibility-Cut-Off Study: For each drug, 9 concentration levels were tested. For each concentration, there were 2 runs per day for 30 days, across 3 device lots, and by 3 operators.
    • This means 9 concentrations * 2 runs/day * 30 days * 3 lots * 3 operators = 4860 total tests per drug analyte for the precision study.
    • Each concentration within each operator/lot combination was tested 60 times (2 runs/day * 30 days). So for each specific concentration, lot, and operator, n=60.
  • Comparison Studies (Method Comparison):
    • Negative oral fluid: 360 samples (across all operators and sites for each drug).
    • Positive oral fluid at various ranges:
      • +50% cut off: For D-Amphetamine, 183 samples. For Cocaine, 186 samples. For d-Methamphetamine, 189 samples. For Morphine, 180 samples. For Phencyclidine, 192 samples. For Delta-9-Tetrahydrocannabinol, 195 samples.
    • The total number of samples for the comparison study for each drug is 360 (negatives) + (sum of the positive ranges for that drug). For example, for D-Amphetamine: 360 + 93 + 74 + 180 + 183 = 890 samples. This applies similarly to other drugs.

• Data Provenance: The document states "Method comparison studies for the LYHER Oral fluid Multi-Drug Test Kit(Cube) were performed at three testing sites with three operators at each site." The location of these sites is not explicitly mentioned (e.g., country of origin), but the submitter is based in China. The data origin is prospective as samples were prepared by spiking known concentrations into negative oral fluid for analytical studies.

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

• Ground Truth Establishment: The ground truth for the test set for both the precision and comparison studies was established by Laboratory Confirmed Concentrations, specifically using LC/MS (Liquid Chromatography/Mass Spectrometry). For the precision study, it states: "Each drug concentration was confirmed by LC/MS." For the method comparison studies, it states: "Operators tested the samples using the candidate device and the results were compared to LC/MS results."
• Number of Experts/Qualifications: LC/MS is a laboratory analytical method, not reliant on subjective expert interpretation like radiological imaging. Therefore, there were no "experts" in the sense of human annotators (e.g., radiologists) involved in establishing the ground truth via consensus or adjudication. The "experts" would be the qualified laboratory personnel performing and interpreting the LC/MS results, whose qualifications are implicit given the professional standards for such testing.

4. Adjudication method for the test set

• Since LC/MS is used to establish quantitative drug concentrations, and the device provides a qualitative "positive" or "negative" result based on a defined cutoff, there is no expert adjudication method (like 2+1, 3+1) mentioned or necessary. The device's result is compared directly to the LC/MS result relative to the established cut-off.

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 question is not applicable to this device. This is a qualitative diagnostic test (immunoassay) for drug detection in oral fluid, not an AI-powered image analysis device that assists human readers. The "operators" mentioned are performing the test, not interpreting complex medical images.

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

• This device is a standalone test (a rapid lateral flow immunoassay), essentially an "algorithm only" in the sense that its chemical reactions produce a visual result (line presence/absence). Human interaction involves collecting the sample, applying it to the device, and visually interpreting the presence or absence of test lines. There isn't a separate "algorithm" that operates outside of the device itself to interpret the results. The performance data presented measures the device's inherent analytical accuracy against known concentrations and LC/MS.

7. The type of ground truth used

• The ground truth used for both precision and comparison studies was laboratory-confirmed drug concentrations via LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and quantitative analytical method, considered a gold standard for drug detection and quantification.

8. The sample size for the training set

• This device is a lateral flow immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance is based on the inherent chemical and biological properties of the reagents and test strip design. Therefore, the concept of a "training set" for model development is not applicable. The studies described are analytical validation studies, not AI model training.

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

• As explained in point 8, there is no "training set" for an AI model. The ground truth for the analytical validation (which is analogous to testing the device's inherent design performance) was established by LC/MS confirmation of spiked drug concentrations in oral fluid.

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BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine.

Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows:

The cassette test may be configured as single drug test in any drug analytes listed in the table.

The test provides 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.

For in vitro diagnostic use only. The test is intended for over the counter use.

BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam,

Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The cassette test may be configured as single drug test in any drug analytes listed in the table.

The test provides 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.

For in vitro diagnostic use only. The test is intended for prescription use.

The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are immunochromatographic assays that use a lateral flow system for the qualitative detection of of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-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

The document describes the performance of the BIO-VENTURE Rapid Amphetamine Test Cassette and similar rapid test cassettes for other drugs (Oxazepam, Cocaine, Methamphetamine, Morphine, Marijuana). These are qualitative lateral flow immunoassays designed for both OTC and Rx use.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by their ability to accurately distinguish between drug concentrations above and below specified cut-off levels. The primary performance metrics presented are precision, cut-off verification, interference, specificity, and comparison with GC/MS results. For the lay-user study, the acceptance criteria are a high percentage of correct results near the cut-off concentrations and ease of use/understanding for lay users.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: For each drug assay (AMP, COC, Oxazepam, MET, MOP, THC), there were 6 drug concentrations tested (from -100% to +100% cut-off, skipping -75%, +75%, and -50%, but then showing -75% and +75% in the table). Each concentration likely involved multiple replicates over 25 days across 3 lots and 6 operators.
     • The tables show results for 6 concentrations per lot, with 50 results per concentration (e.g., 50-/0+ means 50 negative, 0 positive). With 3 lots and 6 operators, performing 9 samples for 25 days per device, this is a very large number of total tests, difficult to sum precisely from the given table format for all concentrations. However, for a given concentration and lot, it appears 50 tests were performed (e.g., 50-/0+).
   • Cut-off Verification: 125 samples tested per drug (equally distributed at -50%, -25%, Cut-Off, +25%, +50% cut-off). Tested using three different lots of each device by three different operators.
   • Interference & Effect of Specific Gravity/pH: Not explicitly stated, but implies a similar number of samples at 25% below and 25% above cut-off for each interference/pH/SG factor.
   • Comparison Studies (Clinical Samples):
     • Amphetamine: 87 samples
     • Cocaine: 80 samples
     • Oxazepam: 80 samples
     • Methamphetamine: 81 samples
     • Morphine: 81 samples
     • Marijuana: 82 samples
   • Lay-User Study: For each drug, 20 samples were tested at each of 7 concentration levels (total 140 samples per drug type).
   • Data Provenance: Not explicitly stated regarding country of origin for the clinical samples. The precision samples were prepared by spiking drug in negative samples. The clinical samples were "unaltered clinical samples." The studies were performed "in-house" and at "three intended user sites" (for the lay-user study). The document refers to Shanghai Venture Bio-Tech CO., Ltd. in China, suggesting an origin in China for the test execution, though clinical samples might be from other regions. The studies are prospective in nature, as they involve testing samples under controlled conditions to evaluate device performance.

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

   • For the Precision Study, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is considered the preferred confirmatory method for drug testing, thus a highly accurate and objective ground truth method. The document states: "Each drug concentration was confirmed by GC/MS."
   • For the Method Comparison Studies (Clinical Samples), the ground truth was also established by GC/MS results. The samples were "compared to GC/MS results."
   • For the Lay-User Study, the concentrations of the samples were also confirmed by GC/MS.
   • The document does not explicitly state the number or qualifications of experts (e.g., radiologists) involved in establishing ground truth, as the ground truth here is analytical (GC/MS) rather than expert consensus on medical images.

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

   • No adjudication method (like 2+1 or 3+1 expert consensus) is mentioned. The ground truth for all performance studies (precision, method comparison, lay-user study) was based on GC/MS, which is an objective chemical method and generally does not require human adjudication in the same way image interpretation might. For the clinical sample comparison, the device results were simply compared against the GC/MS result.

4. 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 to the described device. The device is a rapid diagnostic test (lateral flow immunoassay) for detecting drugs in urine, not an AI-assisted diagnostic tool for human readers interpreting medical images. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

   • This is generally applicable because the device itself is a standalone test that produces a visible result (lines on a cassette). Its performance is evaluated independently.
   • The "Comparison Studies" with clinical samples and the "Precision Studies" are forms of standalone performance evaluation for the device when operated by trained laboratory personnel.
   • The "Lay-user study" also assesses the device's standalone performance, but crucially, it evaluates how well untrained individuals can interpret the device's results.

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

   • The primary ground truth used for all performance evaluations (precision, clinical comparison, lay-user study samples) was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the laboratory gold standard for confirming drug presence and concentration.

7. The sample size for the training set:

   • The document describes a medical device (rapid immunoassay cassette), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI/ML model development. The device's "training" corresponds to its chemical and physical design and manufacturing process.

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

   • Not applicable, as there is no AI/ML training set. The ground truth for the testing of these devices was established using GC/MS.

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The OralTox® Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone in human oral fluid at the cutoff concentrations listed below and their metabolites:

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to detect intermittent dosing of Oxycodone. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive.

The OralTox Oral fluid Drug Test is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine, Phencyclidine. Oxycodone and Methadone (target analytes) in human oral fluid. The products are single-use in vitro diagnostic devices. Each test kit contains a test cup, a package insert and a sample collection sponge. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the OralTox® Oral fluid Drug Test, a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of several drugs in human oral fluid. This submission is a 510(k) premarket notification, indicating the device is intended to be substantially equivalent to previously marketed devices.

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

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device are related to its analytical performance in detecting specific drugs at defined cutoff concentrations. The studies performed focus on demonstrating the accuracy and reliability of the device in comparison to a confirmed analytical method (LC/MS/MS).

Table of Acceptance Criteria and Reported Device Performance (Methadone and Oxycodone - as these were the focus of new data in this submission)

• Lot 1 (Methadone):
  -100% to -50% cut-off: 60-/0+ (100% negative)
  -25% cut-off: 54-/6+ (90% negative, 10% positive)
  Cut-off: 49+/11- (81.7% positive, 18.3% negative)
  +25% to +100% cut-off: 55+/5- (91.7% positive), 60+/0- (100% positive)
• Lot 2 (Methadone): Similar performance, with 55-/5+ at -25% cut-off and 48+/12- at cut-off.
• Lot 3 (Methadone): Similar performance, with 55-/5+ at -25% cut-off and 50+/10- at cut-off.

Method Comparison (Methadone):

• Drug Free &

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The Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites:

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry (LC/MS/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 OralTox Oral fluid Drug Test is immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Opiates and Phencyclidine (target analytes) 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.

The document provided is a 510(k) summary for the Premier Biotech Inc. OralTox Oral Fluid Drug Test. It describes the device, its intended use, and the performance studies conducted to demonstrate substantial equivalence to a predicate device.

Key takeaway for the Acceptance Criteria and Study:

The acceptance criteria for this device, a qualitative drug test, are primarily established through analytical performance studies, specifically assessing precision/reproducibility around the cutoff concentrations, and method comparison studies against a reference method (LC/MS/MS). The device's performance is demonstrated by the percentage of correct results for samples at various concentrations relative to the defined cutoff values.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria as a percentage or specific threshold for "correct results" within the tables. However, based on the presentation of "The percentage of correct results (%)", the implicit acceptance criterion is a high percentage of agreement with the LC/MS/MS reference method, especially for drug-free samples, samples less than half the cutoff, and high positive samples (where 100% agreement is consistently achieved). For "near cutoff" samples, some deviation is expected due to the nature of a qualitative test and the inherent variability around the cutoff.

Here's a consolidated table of reported device performance based on the "Method Comparison Studies" for each drug:

Note: There appears to be a typo in the "Cannabinoids" table for "Drug-Free" in the "No. of Negative" column (327 instead of 359). Assuming the percentage is truly 100%, the negative count should be 359.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • The "Method Comparison Studies" involved a total of 852 samples across all drug types. The sample sizes for each drug category within these studies are detailed in the table above, ranging from 477 (Phencyclidine) to 852 (Methamphetamine, although the overall total is stated as 852, so these numbers represent the number of samples relevant to each specific drug).
  • For the "Precision-Reproducibility-Cut-Off" studies, 60 tests were performed for each concentration of each drug across 3 lots (2 runs per day for 10 days per device lot, resulting in 2x10x3 = 60 tests per concentration). There were 9 concentrations tested for each drug, leading to 540 tests per drug type for this study (60 x 9).
• Data Provenance: The document does not specify the country of origin of the data. It mentions that the "Method comparison studies for the Oral fluid Drug Test were performed at three testing sites." The data appears to be prospective as samples were tested using the OralTox device and compared to LC/MS/MS results.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of "experts" in the context of establishing ground truth for the test set. The ground truth was established by Liquid Chromatography/Mass Spectrometry (LC/MS/MS), which is a highly accurate analytical method, not human expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by LC/MS/MS, a machine-based analytical method, there was no human "adjudication" process needed. The comparison was direct between the device's qualitative result and the quantitative LC/MS/MS result interpreted against the cutoff.

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

Not applicable. This device is a qualitative in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

6. Standalone Performance (Algorithm Only)

The performance described in the "Analytical Performance" and "Comparison Studies" sections represents the standalone performance of the OralTox Oral Fluid Drug Test. This device is an immunochromatographic assay; it does not involve a separate "algorithm" in the typical sense of AI/ML. The results presented are the device's ability to correctly classify samples based on its chemical/biological reaction, without human interpretation beyond reading the visual result.

7. Type of Ground Truth Used

The primary ground truth used for the comparison studies was Liquid Chromatography/Mass Spectrometry (LC/MS/MS). For the precision studies, samples were prepared by spiking known concentrations of drugs into negative oral fluid samples, and these concentrations were confirmed by LC/MS/MS. This is considered an analytical, highly accurate method for determining drug concentrations.

8. Sample Size for the Training Set

The concept of "training set" is not applicable here. This device is a chemical assay, not a machine learning or AI model that requires a training set. Its "performance" is based on its inherent analytical characteristics determined through laboratory testing with controlled and real-world samples.

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

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

In summary: The OralTox Oral Fluid Drug Test demonstrates its acceptance criteria through robust analytical and method comparison studies, relying on LC/MS/MS as the gold standard for ground truth. The device's performance is shown to be highly accurate, especially for drug-free and high-positive samples, with expected variability around the defined cutoff concentrations.

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AssureTech 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 tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup 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.

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

AssureTech Methamphetamine Tests are immunochromatographic assays for the qualitative determination of d-Methamphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Strip format, a Cup format, a Dip Card format and a Turn Key Split Cup 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.

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

AssureTech Phencyclidine Tests are immunochromatographic assays for the qualitative determination of Phencyclidine in human urine at cut-off concentration of 25 ng/mL. The tests are available in a Strip format, a Dip Card format and a Turn Key Split Cup 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.

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

The AssureTech Methamphetamine Tests, AssureTech Phencyclidine Tests, and AssureTech Marijuana Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Methamphetamine, Phencyclidine and Marijuana (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.

The provided text describes the analytical and user performance of various AssureTech drug tests (Methamphetamine, Phencyclidine, and Marijuana) across different formats (Strip, Dip Card, Cup, Turn Key Split Cup). The information outlines specific studies conducted to demonstrate the device meets acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in percentages (e.g., "must achieve 90% accuracy"). Instead, it presents results for concentrations at or around the cut-off, and above/below it, demonstrating the device's ability to correctly identify positive and negative samples.

Here's a table summarizing the reported device performance for Methamphetamine, Phencyclidine, and Marijuana tests, based on the precision and comparison studies, which effectively serve as a demonstration of meeting implied acceptance criteria for qualitative immunoassay performance.

Implicit Acceptance Criteria: The device should consistently provide correct qualitative results (positive or negative) around and beyond the defined cut-off concentrations, as confirmed by a gold standard (GC/MS). For concentrations significantly below the cut-off, the device should report negative, and for concentrations significantly above, it should report positive. At the cut-off itself, there might be some variability, but a strong trend toward expected results is desired. The lay-user study indicates a high percentage of correct results.

Reported Device Performance (Excerpted and Summarized):

2. Sample Sizes and Data Provenance:

• Precision Studies: Samples were prepared at various concentrations around the cut-off (-100%, -75%, -50%, -25%, cut-off, +25%, +50%, +75%, +100%). For each concentration level, 50 tests were performed (2 runs per day for 25 days). This implies 450 tests per lot per device type for each drug (9 concentration levels * 50 tests). With 3 lots per device and 4 device formats for each of the 3 drugs, the total number of precision tests is substantial (e.g., 450 * 3 lots * 4 formats * 3 drugs = 16,200).

• Comparison Studies (Expert Review): For each drug and each device format, 80 unaltered clinical samples were used (40 negative and 40 positive). These were "blind labeled."

• Lay-user Study: 1638 lay persons participated. They were given blind-labeled urine samples from various concentration levels (Negative, +/-75%, +/-50%, +/-25% of the cutoff). The tables show results for 21 samples per concentration level, for each drug and each device type. Considering there are 7 concentration levels listed, and assuming all 4 formats for all 3 drugs were tested, this amounts to a significant number of samples tested by lay users (21 samples/level * 7 levels * 4 formats * 3 drugs = 1,764 total sample tests, which broadly aligns with "1638 lay persons").

• Data Provenance: The document states "Method comparison studies... were performed in-house..." and "Lay-user study was performed at three intended user sites." The country of origin is not explicitly stated for the clinical samples, but the submitting company is based in Hangzhou, China. The studies appear to be prospective as samples were prepared at specific concentrations and tested.

3. Number of Experts and Qualifications:

• Expert Review (Comparison Study): Three laboratory assistants ("Viewer A", "Viewer B", "Viewer C") were used to read the devices. Their specific qualifications (e.g., years of experience) are not provided in this excerpt, only their role as "laboratory assistants."
• Ground Truth Establishment: The ground truth for the test set (clinical urine samples) in the comparison studies was established using Gas Chromatography/Mass Spectrometry (GC/MS), which is stated as the "preferred confirmatory method" and considered a gold standard for drug detection. For precision studies, samples were "prepared by spiking drug in negative samples" and "Each drug concentration was confirmed by GC/MS."

4. Adjudication Method for the Test Set:

• No explicit adjudication method (e.g., 2+1, 3+1 consensus) is described for the "Viewer" results in the comparison studies. The results for each "Viewer" are presented independently. Discordant results are specifically listed, indicating individual discrepancies rather than a pooled or adjudicated outcome from the laboratory assistants.

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

• No MRMC comparative effectiveness study was done in the context of human readers improving with AI vs. without AI assistance. This document describes the performance of a standalone in vitro diagnostic device (immunochromatographic assay) and its comparison to a gold standard (GC/MS), along with a lay-user study. It does not involve AI assistance for human readers.

6. Standalone (Algorithm Only) Performance:

• The devices themselves are qualitative immunochromatographic assays which provide a visual result (line appears or not). Therefore, their performance, as described in the precision and comparison studies, is essentially standalone performance. There isn't an "algorithm" in the typical AI sense; the "algorithm" is the biochemical reaction and visual interpretation of the test strips/cups. The results tabulated for the "Viewers" (laboratory assistants) and "Lay persons" represent human interpretation of these standalone devices.

7. Type of Ground Truth Used:

• The primary ground truth used for validating the device performance is Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate chemical method for confirming the presence and concentration of specific substances in urine samples.
• For the lay-user study, the ground truth was also established by GC/MS of the prepared urine samples.

8. Sample Size for the Training Set:

• This document describes performance validation studies for a medical device (AssureTech drug tests), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device operates based on fixed immunochromatographic principles. The "precision" and "comparison" studies serve as validation of the device's inherent design and manufacturing consistency.

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

• As there is no AI algorithm training set, this question is not applicable. The device's operational principles are based on biochemical interactions, not learned patterns from a training dataset.

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Wondfo Methamphetamine Urine Test (MET 300) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use.

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.

Wondfo Oxazepam Urine Test (BZO 200) is an immunochromatographic assay for the qualitative determination of Oxazepam in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use.

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.

Immunochromatographic assays for Methamphetamine and Oxazepam Urine Tests use a lateral flow, one step system for the qualitative detection of D(+)-Methamphetamine and Oxazepam (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. Oxazepam is part of the Benzodiazepine class of drugs of abuse.

Here's a summary of the acceptance criteria and study details for the Wondfo Methamphetamine Urine Test (MET 300) and Wondfo Oxazepam Urine Test (BZO 200), based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for drug testing devices like these are typically based on the accurate classification of samples relative to a defined cut-off concentration. While explicit "acceptance criteria" percentages are not directly stated in the document, the precision and comparison studies demonstrate the device's ability to correctly identify samples around the cut-off.

The reported performance indicates that:

• For concentrations below -25% Cut-Off, all samples were reported as Negative.
• For concentrations at and above +25% Cut-Off, all samples were reported as Positive.

This suggests an implied acceptance criterion of 100% agreement for samples sufficiently far from the cut-off. For samples at the cut-off, a high percentage of positive results is expected, though not necessarily 100% due to inherent variability allowed around the cut-off.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: For each drug (MET 300 and BZO 200) and each format (Cup, Dip Card), 8 concentrations were tested (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100% of cut-off).
     • Each concentration was tested two runs per day for 25 days across 3 lots of the device. This means for each distinct drug/format (e.g., MET 300 Cup), there were: 8 concentrations x 2 runs/day x 25 days/run x 3 lots = 1200 tests.
     • The exact number of unique "samples" is not explicitly stated beyond "samples prepared by spiking drug in negative samples." It implies contrived samples.
   • Cut-off Verification: 150 samples were used (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off). These were tested using three different lots of each device by three different operators. (150 samples x 3 lots x 3 operators = 1350 tests per drug)
   • Interference Study: "drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level" were spiked with potential interferents. These were tested using three batches of each device for both Dip Card and Cup formats. The number of unique samples is not specified.
   • Specificity Study: Various compounds were tested against three batches of each device for both Dip Card and Cup formats. The number of unique samples is not specified.
   • Urine Specific Gravity and pH Effect: Urine samples with varying specific gravity (1.0001.035) or pH (49) were spiked at -25% and +25% of Cut-Off. These were tested using three batches of each device for both Dip Card and Cup formats. The number of unique samples is not specified.
   • Comparison Studies:
     • MET 300: 80 unaltered clinical samples were used (40 negative and 40 positive). These were tested by three laboratory assistants.
     • BZO 200: 80 unaltered clinical samples were used (40 negative and 40 positive). These were tested by three laboratory assistants.
   • Data Provenance: The study was performed "in-house" and used "unaltered clinical samples" for the comparison studies. The country of origin of these clinical samples is not specified, but the submitter is from Guangzhou, P.R. China. The samples were likely retrospective, as they were "blind labeled" and then retrospectively compared to GC/MS results.

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

   • Ground Truth Establishment: For the comparison studies, the ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is considered the "preferred confirmatory method" and is an objective, analytical gold standard rather than expert consensus.
   • No "experts" in the clinical sense (e.g., radiologists) were used to establish the ground truth; it was established by chemical analysis.

3. Adjudication method for the test set:

   • For the comparison studies, the Wondfo results from each of the three "viewers" (laboratory assistants) were individually compared to the GC/MS ground truth. There is no mention of an adjudication process among the viewers' interpretations of the Wondfo device to reach a single "device" result; each viewer's interpretation stands separately. The GC/MS results serve as the objective truth against which each viewer's reading of the rapid test is compared.

4. 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 was not done.
   • This device is a rapid diagnostic test based on immunochromatography, not an AI-based imaging or interpretive device. Therefore, there is no AI component, and no effect size for human readers with and without AI assistance is applicable or reported.

5. 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 in the context of AI.
   • This is a qualitative rapid diagnostic test where human observation of a colored line determines the result. While the chemical reaction is the "algorithm," the interpretation traditionally involves a human "in-the-loop." The precision studies and cut-off verification can be considered standalone performance in the sense that the device's chemical reactions perform consistently with known spiked concentrations, but the final reading is still noted as being performed by operators/viewers.

6. The type of ground truth used:

   • GC/MS (Gas Chromatography/Mass Spectrometry) was used as the ground truth for confirming drug concentrations in samples for the precision studies, cut-off verification, and method comparison studies. This is a highly accurate and objective analytical method.

7. The sample size for the training set:

   • The document describes performance studies for the device, which are typically analogous to validation or test sets. There is no mention of a "training set" in the context of machine learning or AI, as this is a traditional immunochromatographic assay.
   • The document implies that the device (likely the antibodies and reagent concentrations) was developed through an internal R&D process, but no specific dataset labeled as a "training set" with associated size is disclosed here.

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

   • As no "training set" for an algorithm is described, this question is not applicable. The components of the assay (antibodies, drug-protein conjugates) would have been developed based on known chemical specificities and binding affinities, likely validated against known concentrations of analytes, but not in the format of a "ground truth for a training set" as it would be for an AI model.

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TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests.

This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/11-nor-△-THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.

The UNISCAN-DoA system includes UNISCAN-DoA scanner and mAMP/Opi/THC panel test.

The UNISCAN-DoA scanner is a scientific measurement device for color intensity of developed test strip. The color intensity of a test line is detected by the contact image sensor (CIS) inside the device.

The test strip of UNISCAN-DoA system is a one-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Methamphetamine, Opiates, and THC (Cannabinoid).

The device contains a membrane strip, which is pre-coated with drug-protein conjugate at the test region of the membrane strip. A wicking pad containing anti-drug monoclonal antibody-conjugate is placed at one end of the membrane. The device contains a control region which has a different antigen/antibody from the test region.

The assay relies on the competition for binding antibody between drug conjugate and free drug that may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for limited amount of antibody-colloidal gold conjugate. If the drug is present in the urine specimen, it will prevent the binding of drug conjugate to the antibody. Therefore, the color intensity of the test line is reduced. The higher the drug concentration is present in the urine specimen, the lower the color intensity is in the test line of a strip. The color intensity of a test line is inversely proportional to the drug concentration in the urine specimen. The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner. Once a developed test strip is inserted into the scanner and is scanned by the device, the color intensity of a test line is detected by the contact image sensor (CIS) inside the device and the signal is converted to drug concentration according to the stored calibration curve equation and its coefficients. The qualitative result is then displayed on the LCD screen of the device.

A control line is present at the control region to work as procedural control. This colored band should always appear at the control region regardless the presence of drugs or metabolite. The UNISCAN-DoA scanner automatically detects the color intensity of a control line. If the control line of an inserted test strip does not be detected by the device, "Strip is Failed!" will be displayed on the LCD screen of the device.

The provided text describes the UNISCAN-DoA system, which consists of a scanner and a mAMP/Opi/THC panel test for qualitative detection of Methamphetamine, Opiates, and THC in human urine. The performance is evaluated against GC/MS analysis.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a pass/fail threshold. However, it presents "Agreement among positives" and "Agreement among negatives" as key performance metrics. We can infer that high percentages in these categories are desirable for acceptance.

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

• Sample Size for Test Set:
  • mAMP: 97 urine specimens
  • Opi: 94 urine specimens
  • THC: 94 urine specimens
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions studies were conducted to evaluate performance.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human reader improvement with AI assistance. The device is a standalone immunoassay system, not an AI-assisted interpretation system for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was clearly done. The performance metrics (Agreement among positives/negatives) are reported for the UNISCAN-DoA system itself, comparing its results to a confirmed analytical method (GC/MS).

7. Type of Ground Truth Used

The ground truth used was Gas Chromatography/Mass Spectroscopy (GC/MS) analysis. This is stated as the recommended confirmatory method: "To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method."

8. Sample Size for the Training Set

The document does not provide information on a separate training set or its sample size. The calibration curve (which could be considered part of model training/fitting) is mentioned: "The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner." However, the data used for this calibration is not specified as a "training set" with details like sample size. It's more implied as part of the initial device development.

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

As mentioned above, the document does not explicitly detail a separate "training set" or how its ground truth was established. The calibration curve's coefficients are determined by "nonlinear regression based on the experimental data," but the specifics of this experimental data and its ground truth establishment are not provided for a distinct training phase. It's likely that standards and known concentrations were used, but not specified as a "training set" with ground truth in the context of the study reported.

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Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Acro Rapid MDMA Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL.

The provided text contains information about the Acro Biotech Rapid MDMA Urine Test and its FDA 510(k) clearance. However, it does not include the detailed study information required to fully answer your request regarding acceptance criteria and performance data. The document is an FDA clearance letter and an Indications For Use form, focusing on regulatory approval rather than a comprehensive study report.

Therefore, I cannot provide a complete answer with all the requested details. However, I can extract what is present and then indicate what information is missing.

Information Extracted from the Provided Text:

• Device Name: Acro Biotech Rapid MDMA Urine Test
• Intended Use: Qualitative detection of MDMA in human urine at a cutoff of 500 ng/mL. It is a lateral flow, rapid immunoassay for laboratory use only.
• Result Type: Visual qualitative result.
• Preliminary Nature: Provides only a preliminary result; clinical consideration and professional judgment are needed. Confirmation with a more specific alternate chemical method (preferably GC/MS) is required for positive results.

Attempt to Answer Based on Limited Information (with significant gaps):

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

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

• Sample Size for Test Set: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).

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)

• Not provided. For a drug test, the ground truth is typically established by a reference method like GC/MS, not expert consensus on interpretation. However, the document does not detail this.

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

• Not applicable/Not provided. For a laboratory immunoassay, adjudication by human experts in the typical sense for imaging or clinical diagnosis is not usually conducted. The comparison is against a reference method.

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

• Not applicable. This device is a rapid immunoassay, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

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

• Yes, implicitly. As an immunoassay, its performance is evaluated in a "standalone" manner against a reference method (GC/MS). The document, however, does not provide performance results.

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

• The document implies that Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred method for confirmation, strongly suggesting this would be the ground truth used in performance studies.

8. The sample size for the training set

• Not applicable/Not provided. This is an immunoassay, not a machine-learning algorithm that requires a training set in the typical sense.

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

• Not applicable (see point 8).

Summary of Missing Information:

The provided document is a regulatory approval letter and indications for use. It does not contain:

• Specific performance metrics (sensitivity, specificity, accuracy, precision, cross-reactivity, interference studies) for the device.
• The sample sizes used in any validation studies.
• Details on how ground truth was established by the manufacturer's internal studies (though it implies GC/MS would be used for confirmation outside the scope of the rapid test).
• Any information regarding the design (prospective/retrospective), data provenance, or geographical origin of samples for performance studies.
• Any information related to multi-reader studies or AI assistance, as this is a qualitative immunoassay.

To obtain the detailed study information, one would typically need to consult the full 510(k) summary or submission dossier, which is publicly available on the FDA website for cleared devices but not included in this excerpt.

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TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drug or drug metabolite in urine at or above the stated cutoff concentrations:

Cutoff Concentrations:

• Amphetamines: 1000 ng/mL
• Benzodiazepines: 200 ng/mL
• Cocaine metabolite: 300 ng/mL
• Methamphetamine: 500 ng/mL
• Methamphetamine: 300 ng/mL
• Morphine: 300 ng/mL
• Morphine (M2K): 2000 ng/mL
• Phencyclidine (PCP): 25 ng/mL
• Tetrahydrocannabinols: 50 ng/mL

TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use in the qualitative detection of amphetamines (d,1-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), and methamphetamine (d-methamphetamine 300 ng/mL), morphine (morphine 300 ng/mL), and morphine (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL) and THC (11-nor-Δ'-THC-9-carboxylic acid 50 ng/mL).

The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber.

Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrance. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band.

When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative") result is the absence of a blue band.

An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

I am sorry, but I am unable to extract the detailed information requested regarding the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) summary for a medical device (drug test cups) and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and performance study results.

The document states the intended use and cutoff concentrations for various drugs, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for a test set.
• Information on experts used for ground truth, adjudication methods, or specific expert qualifications.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
• Results of a standalone algorithm performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

The text mentions that the assays are based on "microparticle capture inhibition" and describes the general principle of how the test works (formation/absence of a blue band). It also states that the modified devices "have the same intended use and incorporate the same fundamental scientific technology as the predicate devices."

To provide the requested information, a different type of document, such as a detailed study report or clinical trial summary, would be necessary.

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Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only.

This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL.

The provided text is an FDA 510(k) clearance letter for the Acro Rapid Methamphetamine Urine Test. It includes the device name, regulation information, significant equivalence determination, and indications for use. However, it does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or other specifics of performance testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is a clearance letter, not a performance study report.

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