(40 days)
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:
| Drug ( Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Benzoylecognine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (OPI2000/MOP300) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
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):
| Test Characteristic | Drug (Cutoff) Examples | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | AMP 500 ng/mL, BUP 10 ng/mL, etc. | +100%, +75%, +50%, +25% Cutoff: 100.0% Positive (Across all tested drugs and cutoffs) |
| -100%, -75%, -50%, -25% Cutoff: 100.0% Negative (Across all tested drugs and cutoffs) | ||
| Cutoff: |
- 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.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).