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Pocguide Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

The single or multi-test panels can consist of up to the above listed analytes in any combination. The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive 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.

For over-the-counter use. For in vitro diagnostic use only

Pocguide™ Multi-Drug Test Panel and Pocguide™ Multi-Drug Test Panel OTC are immunochromatographic assays that use a lateral flow system for the qualitative detection of single drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic devices.

This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.

The provided document describes the Pocguide Multi-Drug Test Panel and Pocguide Multi-Drug Test Panel OTC, which are in vitro diagnostic devices for qualitative and simultaneous detection of various drugs in human urine.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of qualitative diagnostic device are typically related to its analytical performance, specifically precision (reproducibility) around the cutoff concentration, and its ability to correctly identify positive and negative samples when compared to a confirmed method (method comparison).

Acceptance Criteria (Implied based on study design and regulatory context for qualitative drug tests):

• Precision/Reproducibility: A high percentage of agreement (e.g., typically >80%) for samples near the cutoff (e.g., +/- 25% cutoff, cutoff itself) over multiple lots and runs, and 100% agreement for samples far from the cutoff (e.g., +/- 100% cutoff).
• Method Comparison: High overall agreement (sensitivity and specificity) with a gold standard confirmatory method (LC/MS or GC/MS) for clinical samples, especially for true positive and true negative samples. Acceptable performance for samples near the cutoff where some discordance is expected due to the nature of qualitative assays.
• Analytical Specificity (Cross-Reactivity): No significant cross-reactivity with common substances or structurally similar compounds to avoid false positives.
• Interference: No interference from common physiological substances found in urine.
• Lay-User Study (for OTC devices): High agreement with trained professionals and ease of use for the intended lay user.

Reported Device Performance (from "Precision/Reproducibility" and "Method Comparison" sections):

• AMP 500: 82.0% Positive, 18.0% Negative
• BUP 10: 84.0% Positive, 16.0% Negative
• BAR 300: 82.7% Positive, 17.3% Negative
• And similar ranges for other drugs listed in Table 2. Each drug showed similar performance around the cutoff. |
  | Method Comparison | AMP 1000 ng/mL, AMP 500 ng/mL, BAR 300 ng/mL, etc. | Excellent agreement for Drug-Free, Low Negative, and High Positive Samples: Typically 100% correct classification by the device for these categories (e.g., "Viewer A Positive" for High Positive by LC/MS and "Viewer A Negative" for Drug-Free by LC/MS are 100% for almost all drugs).
  Expected Discordance Near Cutoff: As anticipated for qualitative tests, some samples near the cutoff (especially -25% and +25%) show mixed results (discordance) between the device and LC/MS, as detailed in Table 5 and Table 6 (Discordant results). These are typically within acceptable ranges for qualitative tests, acknowledging the inherent variation around a precise cutoff. |
  | Analytical Specificity | AMP, BUP, BAR, etc. | Tested numerous substances. Most showed no cross-reactivity or very low percentages at very high concentrations, indicating good specificity. Specific cross-reactivity percentages are provided in Table 3. |
  | Interference | N/A - broadly tested | No interference observed for a wide range of common substances and physiological conditions (urine specific gravity 1.000-1.035, pH 4-9) as listed in Tables 4. |
  | Lay-User Study | All Configuration 1 & 2 Drugs | Agreement (%):
• -100%, -75%, -50% Cutoff: 100% negative calls.
• +25%, +50%, +75% Cutoff: Mostly 100% positive calls, some 95% for +25% cutoff.
• -25% Cutoff: 95% negative calls for most drugs.
• Raw numbers show 19/20 or 20/20 correct calls for most categories.
  Ease of Use: All participants indicated instructions were easy to understand and follow (Flesch-Kincaid Grade Level 7). |

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Precision/Reproducibility: For each drug and each cutoff, 50 samples were tested at each concentration level (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%). This was done across 3 lots, so $50 \text{ samples/level} \times 9 \text{ levels} \times 3 \text{ lots} = 1350$ tests per drug. (For AMP alone, this would be $1350 \times 2 \text{ cutoffs} = 2700$ tests).
  • Method Comparison: 100 unaltered clinical samples were used for each target drug (40 negative, 40 positive, and an additional 20 samples around the cutoff as seen in the breakdown of results). So, for 13 drug analytes, this would be $13 \times 100 = 1300$ clinical samples.
  • Cross-Reactivity / Interference: Specific numbers for each substance are not given, but samples were spiked at various concentrations and tested using three lots of each device.
  • Lay-User Study: For Configuration 1, 140 participants (58 male, 82 female). For Configuration 2, 140 participants (56 male, 84 female). Each participant tested 1 blind-labeled sample. For each drug within each configuration, 20 samples were prepared per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75%).
• Data Provenance: The document does not explicitly state the country of origin for the data. The consulting firm is in Shanghai, China, and the applicant's address is Irvine, CA, USA. Given the FDA 510(k) submission, it's implied that the data is intended to be representative and valid for the US market. The studies are described as retrospective as they involve samples prepared at specific concentrations or existing clinical samples compared to a gold standard.

3. Number of Experts and their Qualifications

• For Precision/Reproducibility, Cross-Reactivity, Interference, and Method Comparison: The document does not explicitly state the number of "experts" used to establish ground truth or interpret results. These are quantitative/analytical laboratory tests where the ground truth (concentration by LC/MS or GC/MS) is established by analytical instrumentation. The "Viewers" (A, B, C) mentioned in the Method Comparison section appear to be individuals performing the visual interpretation of the device results, not necessarily independent experts establishing ground truth. Their qualifications are not specified but are implied to be trained laboratory personnel.
• For Lay-User Study: No "experts" were used to establish ground truth for the lay-user study. The ground truth for the samples used in this study was established by LC-MS/MS confirming the spiked drug concentrations.

4. Adjudication Method for the Test Set

• For Precision/Reproducibility, Cross-Reactivity, Interference: No adjudication method is described. The results are reported as counts of positive/negative readings against a known (spiked) concentration.
• For Method Comparison: No explicit "adjudication" among multiple readers is described. Results for the candidate device were observed by "Viewer A, B, C." The comparison is directly between the "Candidate Device Result" (presumably individual Viewer results, though aggregated in Table 5) and the LC/MS reference method. The discordant results in Table 6 specify which viewers made the discordant call (e.g., "Viewer A, B," "Viewer C"). This suggests independent readings by three viewers, but no formal adjudication process to resolve disagreements among them is mentioned; the individual viewer calls are presented relative to the ground truth.
• For Lay-User Study: No adjudication method is mentioned. The tables report the number of positive/negative results per concentration.

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

• No MRMC comparative effectiveness study was done. The study design is an analytical performance study and a comparison study against a laboratory reference method, along with a lay-user study for OTC claims. It assesses device performance in a standalone or simulated user setting, not direct human reader improvement with AI assistance. The device is a lateral flow immunoassay, not an AI-powered diagnostic.

6. Standalone (Algorithm Only) Performance

• This question is not applicable as the device is a lateral flow immunochromatographic assay, not an algorithm or software-based diagnostic. Its performance is inherent to the chemical reactions on the test strip and visual interpretation, not an algorithm.

7. Type of Ground Truth Used

• The primary ground truth used for performance evaluation (Precision/Reproducibility, Method Comparison, Lay-User Study) is analytical confirmation by Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions (LC-MS/MS), which are stated as the "preferred confirmatory methods." This is a highly accurate and quantitative method for determining drug concentrations.

8. Sample Size for the Training Set

• This question is not applicable. The device is a qualitative diagnostic test based on immunoassay principles, not a machine learning or AI-based device that requires a "training set" in the computational sense. The development of the immunoassay itself relies on antigen-antibody binding characteristics and optimization, not a deep learning model.

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

• This question is not applicable for the same reasons as #8. The "ground truth" for developing the test and optimizing its performance would be established through standard immunoassay R&D processes, involving controlled experiments with known concentrations of analytes and cross-reactants, guided by established analytical chemistry principles.

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PocguideTM Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier) Amphetamine (AMP) Buprenorphine (BUP) Secobarbital (BAR) Oxazepam (BZO) Benzoylecgonine (COC) 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) Methamphetamine (MET) Methylenedioxymethamphetamine (MDMA) Morphine (OPI2000/MOP300) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP) Nortriptyline (TCA) Marijuana (THC)
Cut-off level 1000 ng/mL or 500 ng/mL 10 ng/mL 300 ng/mL 300 ng/mL 300 ng/mL or 150 ng/mL 300 ng/mL 1000 ng/mL or 500 ng/mL 500 ng/mL 2000 ng/mL or 300 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL 1000 ng/mL 50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive 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.

PocguideTM Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

The single or multi-test cups can consist of up to the above listed analytes in any combination.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive 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.

Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The document describes the analytical and user performance of the Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup, which are qualitative lateral flow immunochromatographic assays for detecting various drugs in human urine.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the analytical performance (e.g., specific percentages for precision or method comparison). Instead, it presents the results of these studies. For the lay user study, it presents agreement percentages.

However, based on the data presented, the implicit acceptance criteria for the qualitative detection of drugs would be high agreement (ideally 100% at concentrations sufficiently above or below the cutoff) for positive and negative samples, and a certain degree of variability (discordance) near the cutoff, which is expected for qualitative assays.

Here's a summary of the reported performance, primarily from the "Precision/Reproducibility" and "Method Comparison" sections:

Implicit Acceptance Criteria (based on typical assay performance and the provided data)

• Precision/Reproducibility: Consistent qualitative results (Positive/Negative) across multiple runs and lots, especially for concentrations sufficiently above or below the stated cutoff levels. Some variability (mix of positive and negative results) is expected and acceptable around the cutoff concentration, as this is the region where the device is designed to transition between positive and negative readings.
• Method Comparison (Accuracy vs. LC-MS/MS):
  • 100% agreement for Drug-Free samples (true negatives).
  • High agreement for "Low Negative" samples (true negatives well below cutoff).
  • High agreement for "High Positive" samples (true positives well above cutoff).
  • Expected discordance (mix of +/- results) for "Near Cutoff Negative" and "Near Cutoff Positive" samples.
• Lay Person Study: High percentage of agreement on results, demonstrating ease of use and accurate interpretation by lay users. High Flesch-Kincaid reading score/grade level for instructions indicating understandability.

Reported Device Performance

Precision/Reproducibility (See Tables in Section 12.A.a, e.g., Page 8)

• For concentrations at +100%, +75%, +50%, +25% cutoff: Across all drugs and lots, the device consistently reported 0 negative results and 50 positive results (0-/50+) which indicates 100% agreement for samples well above the cutoff.
• For concentrations at -25%, -50%, -75%, -100% cutoff: Across all drugs and lots, the device consistently reported 50 negative results and 0 positive results (50-/0+) which indicates 100% agreement for samples well below the cutoff.
• For the "Cutoff" concentration: As expected for a qualitative test, there was a mix of negative and positive results across all drugs and lots, ranging from 8-/42+ to 17-/33+ (e.g., for AMP 500 Lot 1, 12-/38+ means 12 negative and 38 positive results out of 50 total). This demonstrates appropriate performance around the threshold.

Method Comparison (Accuracy vs. LC-MS/MS) (See Tables in Section 12.B, e.g., Page 19-20)

• Drug-Free Samples: For all drugs and all three operators, the device consistently reported 0 positive results and showed 100% agreement (e.g., 0+ / 13- for AMP 500).
• Low Negative Samples (less than -50% of cutoff): For all drugs and all operators, the device consistently reported 0 positive results and showed 100% agreement (e.g., 0+ / 7- for AMP 500).
• High Positive Samples (greater than +50% of cutoff): For all drugs and all operators, the device consistently reported 100% positive results (e.g., 23+ / 0- for AMP 500).
• Near Cutoff Negative (Between -50% and cutoff) & Near Cutoff Positive (Between cutoff and +50%): As expected for a qualitative assay, there was a mix of positive and negative results in these ranges, indicating the test's activity around the cutoff. The discordant results table (Pages 22-23) provides specific examples of samples that differ from the LC-MS/MS result near the cutoff. For instance, for AMP 500, samples like AL243 (441.6 ng/mL) were read as Positive by the device, while AL036 (501.2 ng/mL) was read as Negative. This is typical for qualitative tests at the cutoff.

Lay Person Study (See Tables in Section 12.C, e.g., Page 25-27)

• Agreement Percentages: For concentrations well below (-100%, -75%, -50% cutoff) and well above (+50%, +75% cutoff) the cutoff, the agreement with the expected result was consistently 100% for all drugs and configurations.
• Near Cutoff: At the -25% and +25% cutoff concentrations, there was slight variability, with agreement mostly at 95.00% (e.g., 19 negative out of 20 at -25% for AMP 500, or 19 positive out of 20 at +25% for AMP 500). This confirms appropriate performance around the cutoff by lay users.
• Instruction Clarity: "All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7," indicating strong performance against this unstated criterion.

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

• Precision/Reproducibility:
  • Sample Size: For each drug, 9 concentration levels were tested (from -100% cutoff to +100% cutoff, including the cutoff). For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. This means 50 tests per concentration per lot, totaling 450 tests per drug per lot for analytical precision. As there are multiple drugs/cutoffs, the total number of individual tests is substantial. (e.g., for AMP 500, 9 concentrations * 50 tests/concentration * 3 lots = 1350 individual tests for AMP 500 alone).
  • Data Provenance: The document doesn't explicitly state the country of origin. Samples were "prepared by spiking target drug in drug-free urine samples," suggesting controlled laboratory conditions rather than native clinical samples. The study appears to be prospective in nature, as it involves preparing samples and running specific experiments.
• Method Comparison Study:
  • Sample Size: 80 "unaltered urine clinical samples" were used for each drug (40 negative and 40 positive). These were compared across three operators. Thus, for each drug, 80 unique clinical samples were tested, with data collected from 3 operators, meaning 240 results per drug.
  • Data Provenance: "Unaltered urine clinical samples" suggests real-world urine specimens. The document doesn't specify the country of origin of these samples. It implies a retrospective use of collected samples or a prospective collection for this specific study.
• Lay Person Study:
  • Sample Size: 280 lay persons participated. Urine samples were prepared at 7 concentration levels per drug (from -100% to +75% cutoff).
  • Data Provenance: The study was likely conducted in a controlled environment as samples were "prepared by spiking drug(s) into drug free-pooled urine specimens." The location (country) of the lay user study is not specified, but it suggests a controlled, prospective study.

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

• Ground Truth for Precision/Reproducibility and Lay Person Study: "Each drug concentration was confirmed by LC-MS/MS." and "The concentrations of the samples were confirmed by LC-MS/MS." LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly accurate analytical chemistry technique. This is an objective, quantitative measurement; therefore, human expert subjective interpretation for ground truth establishment is not typically required.
• Ground Truth for Method Comparison Study: "The samples were blind labeled and compared to LC-MS/MS results." Again, LC-MS/MS is the ground truth, not human experts.

As such, for an in-vitro diagnostic device of this nature, the "ground truth" is established by highly precise analytical instruments (LC-MS/MS), not by human experts. Therefore, the number and qualifications of human experts establishing ground truth are not applicable in the traditional sense of medical image interpretation or clinical diagnosis.

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

Not applicable. The ground truth method (LC-MS/MS) for defining the precise concentration of drugs is an objective chemical analysis, not a subjective human interpretation requiring adjudication. For the device's output, it is a qualitative "positive" or "negative" reading based on visual lines, directly observable without complex adjudication. The method comparison study uses results from 3 operators, but their results are compared against the LC-MS/MS, not adjudicated against each other to define a 'truth'.

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 is an in-vitro diagnostic (IVD) device, specifically a point-of-care, qualitative multi-drug test cup, not an AI-assisted diagnostic tool for human image readers (like radiology AI). Therefore, an MRMC study related to AI assistance for human readers is not relevant to this product.

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

Not applicable. This is a physical, self-contained immunochromatographic test cup that provides a visual reading (lines appearing/disappearing). It does not involve a software algorithm that performs detection independently. Its performance is the "standalone" performance, as it relies on chemical reactions and visual interpretation.

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

The primary ground truth used for performance evaluation is Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions (LC-MS/MS), which are considered the preferred confirmatory methods for drug detection in urine. This is an objective, quantitative chemical analysis.

8. The sample size for the training set

Not applicable. This is a direct chemical/immunological assay device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven model development.

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

Not applicable, as there is no "training set" for this type of medical device. The device operates based on established chemical and immunological principles, not learning from data.

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