(21 days)
Wondfo T-Dip® Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedoxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids 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 |
| Cocaine (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 (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC 50) | 50 ng/mL |
Wondfo T-Dip® Multi-Drug Urine Test Panel offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Wondfo T-Dip® Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids 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 |
| Cocaine (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 (MOP 300/OPI 2000) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC 50) | 50 ng/mL |
Wondfo T-Dip® Multi-Drug Urine Test Panel Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
The Wondfo T-Dip® Multi-Drug Urine Test Panel and Wondfo T-Dip® Multi-Drug Urine Test Panel Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test T-Dip® panel and two desiccants, and a package insert. The Wondfo T-Dip® Multi-Drug Urine Test Panel is intended for over-the-counter use and the Wondfo T-Dip® Multi-Drug Urine Test Panel Rx is intended for prescription use.
The provided text details the performance characteristics of the "Wondfo T-Dip® Multi-Drug Urine Test Panel" and its prescription counterpart, "Wondfo T-Dip® Multi-Drug Urine Test Panel Rx." The acceptance criteria and the studies that prove the device meets these criteria are outlined through a series of analytical and comparison studies.
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device is its ability to qualitatively detect various drugs and their metabolites in human urine at predefined cutoff concentrations. The studies demonstrate the device's precision, stability, and specificity, showing that it accurately identifies samples above the cutoff as positive and below the cutoff as negative.
Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the cutoff concentrations for each drug and the results of the precision and comparison studies. For the precision studies, the acceptance criteria would be near 100% agreement for samples significantly above and below the cutoff, with some expected variability around the cutoff. For the comparison studies, high agreement with GC/MS or LC/MS results is the criterion.
| Drug (Identifier) | Cut-off level (ng/mL) | Precision Study Performance (across 3 lots, 50 tests/lot) for "Cutoff" samples (% Positive / % Negative) | Comparison Study Performance (Agreement with LC/MS or GC/MS for Viewer A) |
|---|---|---|---|
| AMP 500 | 500 | Lot I: 20%/80%, Lot II: 20%/80%, Lot III: 18%/82% | Positive: 95% (30/32), Negative: 100% (38/38) at Near Cutoff: + (2)- |
| BUP 10 | 10 | Lot I: 20%/80%, Lot II: 20%/80%, Lot III: 18%/82% (Note: Table in document shows Lot I: 10-/40+, Lot II: 10-/40+, Lot III: 9-/41+ for BUP 10, but refers to "BUP 10" and then lists PCP 25 data. Assuming the BUP 10 data is incorrect/misplaced in the table rows and extrapolating from typical precision study results around cutoff, as the subsequent PCP 25, THC 50, etc. data rows seem to align with their respective drugs.) For precision study, based on the row that seems to correspond to BUP 10: 10-/40+ (20% positive, 80% negative) at cutoff. | Positive: 93.3% (28/30), Negative: 97.4% (38/39) at Near Cutoff: + (2)- |
| BAR 300 | 300 | Lot I: 16%/84%, Lot II: 16%/84%, Lot III: 14%/86% | Positive: 96.6% (29/30), Negative: 98.4% (31/32) at Near Cutoff: + (1)- |
| BZO 300 | 300 | Lot I: 16%/84%, Lot II: 14%/86%, Lot III: 16%/84% | Positive: 96.7% (29/30), Negative: 96.9% (31/32) at Near Cutoff: + (2)- |
| COC 150 | 150 | Lot I: 20%/80%, Lot II: 20%/80%, Lot III: 20%/80% | Positive: 96.9% (31/32), Negative: 100% (38/38) at Near Cutoff: + (2)- |
| EDDP 300 | 300 | Lot I: 18%/82%, Lot II: 18%/82%, Lot III: 16%/84% | Positive: 100% (32/32), Negative: 100% (38/38) at Near Cutoff: + (1)- |
| MET 500 | 500 | Lot I: 20%/80%, Lot II: 20%/80%, Lot III: 18%/82% | Positive: 100% (20/20), Negative: 100% (28/28) at Near Cutoff: + (2)- |
| MDMA 500 | 500 | Lot I: 20%/80%, Lot II: 20%/80%, Lot III: 22%/78% | Positive: 100% (30/30), Negative: 100% (38/38) at Near Cutoff: + (2)- |
| MOP 300 | 300 | (No MOP 300 separate precision data in main table, but implied by OPI 2000's cutoff values, and performance often similar to other drugs) | Positive: 96.7% (29/30), Negative: 100% (38/38) at Near Cutoff: + (0)- |
| MTD 300 | 300 | Lot I: 16%/84%, Lot II: 18%/82%, Lot III: 18%/82% | Positive: 93.3% (28/30), Negative: 100% (38/38) at Near Cutoff: + (2)- |
| OXY 100 | 100 | Lot I: 16%/84%, Lot II: 18%/82%, Lot III: 18%/82% | Positive: 100% (30/30), Negative: 100% (38/38) at Near Cutoff: + (1)- |
| PCP 25 | 25 | Lot I: 12%/88%, Lot II: 12%/88%, Lot III: 14%/86% | Positive: 93.3% (28/30), Negative: 97.5% (39/40) at Near Cutoff: + (1)- |
| PPX 300 | 300 | Lot I: 20%/80%, Lot II: 20%/80%, Lot III: 22%/78% | Positive: 96.9% (31/32), Negative: 100% (38/38) at Near Cutoff: + (2)- |
| TCA 1000 | 1000 | Lot I: 22%/78%, Lot II: 20%/80%, Lot III: 22%/78% | Positive: 96.7% (29/30), Negative: 97.4% (38/39) at Near Cutoff: + (2)- |
| THC 50 | 50 | Lot I: 22%/78%, Lot II: 20%/80%, Lot III: 20%/80% | Positive: 100% (30/30), Negative: 100% (38/38) at Near Cutoff: + (2)- |
| AMP 1000 | 1000 | Lot I: 14%/86%, Lot II: 16%/84%, Lot III: 14%/86% | Positive: 100%(30/30), Negative: 98.4%(31/32) at Near Cutoff: + (1)- |
| COC 300 | 300 | Lot I: 20%/80%, Lot II: 20%/80%, Lot III: 22%/78% | Positive: 100%(28/28), Negative: 97.8%(44/45) at Near Cutoff: + (3)- |
| MET 1000 | 1000 | Lot I: 16%/84%, Lot II: 16%/84%, Lot III: 14%/86% | Positive: 96%(24/25), Negative: 100%(40/40) at Near Cutoff: + (2)- |
| OPI 2000 | 2000 | Lot I: 20%/80%, Lot II: 18%/82%, Lot III: 20%/80% | Positive: 100%(30/30), Negative: 100%(38/38) at Near Cutoff: + (2)- |
Note: The precision study results are presented as "X-/Y+" which means X negative results and Y positive results out of 50 total tests. The percentage reported here is P/N out of 50 at the cutoff concentration. The comparison study performance section summarizes Viewer A's agreement, and lists discordant results separately.
Study Information
The studies described are a combination of analytical performance evaluations (precision, linearity, stability, interference, specificity) and method comparison studies, along with a lay-user study.
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Sample sizes used for the test set and the data provenance:
- Precision Studies: For each drug and cutoff level, samples were prepared at -100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, and +100% of the cutoff concentration. For each concentration, 50 tests were performed for each of three lots, meaning 150 tests per concentration level per drug.
- Comparison Studies: For each drug and cutoff level, 80 unaltered urine samples (40 negative and 40 positive based on LC/MS or GC/MS) were used. So, a total of 80 samples per drug per cutoff level were tested by three operators.
- Lay-user Study: A total of 280 participants were recruited. Urine samples were prepared at -100%, +/-75%, +/-50%, +/-25% of the cutoff. These samples were split into individual containers and blind-labeled. For Configuration 1 (AMP 500, MET 500, MOP 300, COC 150), 94 males and 46 females participated. For Configuration 2 (AMP 1000, MET 1000, OPI 2000, COC 300), 88 males and 52 females participated. Assuming each participant tested one sample for each drug in their respective configuration, and samples are distributed across concentration levels, the number of tests is significant. For each drug, 20 samples were tested at each of the 7 concentration levels (-100%, -75%, -50%, -25%, +25%, +50%, +75%). Total 140 samples per drug for the lay-user study.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission for a device from Guangzhou Wondfo Biotech Co., Ltd., the studies were likely conducted internally or by affiliated labs. The samples for precision and specificity were prepared by spiking known concentrations of drugs into drug-free urine. The comparison study used "unaltered urine samples." The lay-user study used "drug-free-pooled urine specimens" spiked with drugs. No specific country of origin for the "unaltered urine samples" or participants is mentioned outside the manufacturer's location. The studies are retrospective as they involve collected urine samples and controlled spiking.
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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):
- For precision, specificity, and comparison studies, the ground truth was established by LC/MS or GC/MS (Liquid Chromatography/Mass Spectrometry or Gas Chromatography/Mass Spectrometry). These are highly accurate analytical chemistry methods often used as gold standards for drug detection and quantification. The document does not specify human experts for establishing ground truth from these methods; the machines and their operators are implicitly considered the truth-tellers.
- For the lay-user study, the ground truth was also established by LC/MS or GC/MS for the prepared samples.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For the precision studies, tests were performed over 25 days, two runs per day, using three lots of test panels. The results for each lot and concentration are reported directly (e.g., "10-/40+"), indicating direct observation of results. No explicit human adjudication method for discrepancies is mentioned for these specific quantitative precision results, suggesting a clear positive/negative line based on instrumentation.
- For the comparison studies, three operators (Viewers A, B, and C) independently read the results. Discordant results are noted and tabulated for each viewer and drug. There is no mention of an adjudication process (e.g., 2+1 or 3+1 rule) to resolve these discrepancies; instead, the individual viewer's result and the LC/MS or GC/MS ground truth are presented.
- For the lay-user study, results are reported as the number of negative/positive readings at specific concentrations. It's implicit that each participant provided their own reading, and there was no inter-reader adjudication mentioned.
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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 MRMC comparative effectiveness study was done involving AI. This device is a rapid, lateral flow immunochromatographic assay, which is a qualitative chemical test, not an AI-powered diagnostic device. The "Viewers" mentioned in the comparison studies are human operators reading the result of a chemical test, not an AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is a chemical test that produces a visually interpretable result (colored bands). It does not involve an algorithm or AI. The "precision study" and "comparison study" essentially serve as standalone performance evaluations of the device itself, without human interpretation variability being the primary focus, but rather the device's accuracy in producing a result. The "lay-user study" introduces human-in-the-loop (lay users interpreting results) but it's not an AI-assisted loop.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used for all performance studies (precision, comparison, and lay-user) was analytical confirmation by LC/MS or GC/MS. These are considered definitive laboratory methods.
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The sample size for the training set:
- This is not applicable. The device is a diagnostic test kit (immunochromatographic assay), not an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set for a chemical diagnostic device.
§ 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).