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Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations.
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a postive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Dochek® Multi-Drug Urine Test Cup Pro is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations.
Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device.
For in vitro diagnostic use only.
The test provides only preliminary results. 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. GC/MS or LC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Cup Pro and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic medical devices.
This device is a cup format, with the test strips integrated into the plastic cup provided, and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed in an aluminum foil pouch with two sachets of desiccant. The device is in a ready-to-use format and no longer requires assembly before use.

The provided text describes the Dochek® Multi-Drug Urine Test Cup and Dochek® Multi-Drug Urine Test Cup Pro, which are immunoassays for the qualitative determination of single or multiple drugs in human urine. The acceptance criteria and the studies performed to demonstrate performance are detailed below. It is important to note that the acceptance criteria are implied by the reported performance, as explicit criteria are not stated in terms of thresholds for sensitivity/specificity. Instead, the studies demonstrate accuracy and agreement against a reference method and other concentrations.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence to a predicate device and achieving certain performance levels in precision, accuracy against a reference method, and lay user comprehension.

Notes on the tables below:

• "Cutoff" refers to the specified ng/mL for each drug.
• "+" indicates a preliminary positive result (drug detected).
• "-" indicates a negative result (drug not detected).
• LC-MS/MS is the reference method for confirming drug concentrations.
• The "Percentage of correct results (%)" in the Lay User Study is derived from the reported counts of negative and positive results compared to the expected outcome given the drug concentration relative to the cutoff. For example, a sample at -100% cutoff should be negative, and a sample at +100% cutoff should be positive.

1.1. Precision/Reproducibility Study (Fentanyl (FTY) Example)

1.2. Method Comparison Study (Fentanyl (FTY) Example)

This study compares the device's results to LC-MS/MS, a highly accurate confirmatory method. The "Discordant results" highlight where the device deviated from the LC-MS/MS findings.

Summary of Discordant Fentanyl Results (FTY 1 ng/mL):

1.3. Lay Person Study (Configuration 1 & 2 - Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, OPI, MTD, OXY, PCP, PPX, TCA, THC, 6-MAM, FTY)

This study evaluates the device's performance when used by non-professionals. Results are generally expected to be 100% correct for samples at -100% and +100% of the cutoff, and high percentages for other concentrations (e.g., ≥90-95% for +/-25% of cutoff).

2. Sample Size and Data Provenance

Precision Study:

• Sample Size (Test Set): For Fentanyl, 50 tests were performed at each of the 9 concentration levels (+/-100%, +/-75%, +/-50%, +/-25% of cutoff, and cutoff) across 3 lots, for a total of 9 concentrations * 50 measurements * 3 lots = 1350 tests.
• Data Provenance: Samples were prepared by spiking target drug in drug-free urine samples. The source of the drug-free urine or spiked drugs is not explicitly stated in terms of country of origin. This was a prospective study, with samples specifically prepared for the testing.

Method Comparison Study:

• Sample Size (Test Set): 80 unaltered clinical urine samples were used for each drug (40 negative and 40 positive). For Fentanyl, this means 80 samples were tested.
• Data Provenance: Unaltered clinical urine samples. The country of origin of these clinical samples is not specified. This appears to be a retrospective study using existing clinical samples.

Lay Person Study:

• Sample Size (Test Set): 280 lay users participated.
  • Configuration 1: 140 users (68 male, 72 female).
  • Configuration 2: 138 users (74 male, 64 female).
  • Across 7 concentration levels (+/-100%, +/-75%, +/-50%, +/-25% of cutoff, and cutoff), with 20 samples per concentration level for each drug. This means for each drug, 7 * 20 = 140 results were generated by lay users.
• Data Provenance: Urine samples were prepared by spiking drug(s) into drug-free pooled urine specimens. The source of the drug-free pooled urine or spiked drugs is not explicitly stated in terms of country of origin. This was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• Precision Study: Ground truth for sample concentrations was confirmed by LC-MS/MS. This method is a highly qualified and generally accepted gold standard for drug concentration determination, not relying on human expert interpretation of the test result itself.
• Method Comparison Study: Ground truth was established by LC-MS/MS results. The operators in this study were "three operators" (presumably laboratory personnel or technicians, but their specific qualifications are not detailed). These operators read the device results, which were then compared to the LC-MS/MS ground truth.
• Lay Person Study: Ground truth for sample concentrations was confirmed by LC-MS/MS. The lay users themselves provided the device readings, and the percentage of correct results was calculated against the LC-MS/MS confirmed concentrations.

4. Adjudication Method for the Test Set

• Precision Study: The results are quantitative (counts of positive/negative) based on pre-defined concentrations. No adjudication method is explicitly described for subjective interpretation as the test is qualitative and the results are directly read as positive or negative by trained personnel (implied).
• Method Comparison Study: "Three operators" read the device results. The individual results for each viewer (A, B, C) are presented. There is no explicit adjudication method (e.g., 2-out-of-3 consensus) mentioned to derive a single device result per sample if the operators disagreed. The discordant results table shows instances where operators disagreed, or where the device result from an individual operator disagreed with LC-MS/MS.
• Lay Person Study: Lay users performed the tests independently. There is no mention of an adjudication process among lay users for their readings. Each participant provided a single result for their assigned sample/device.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned to quantify the improvement of human readers with AI assistance versus without AI assistance. The device is a lateral flow immunoassay, not an AI-powered diagnostic for image interpretation or similar tasks often associated with MRMC studies.

6. Standalone Performance Study

Yes, standalone performance was conducted for the device.

• Precision Study: The device's inherent precision was evaluated across different drug concentrations and lots, independent of human interpretation variability (though human reading is still involved for the qualitative result).
• Method Comparison Study: The device's performance against the gold standard (LC-MS/MS) was evaluated by three operators independently, representing a standalone assessment of the device's accuracy in a laboratory setting.
• Lay Person Study: This study specifically assessed the standalone performance of the device when used by the intended lay users, including their ability to follow instructions and interpret results correctly.

7. Type of Ground Truth Used

The primary ground truth used for evaluating the device's accuracy in all relevant studies (Precision, Method Comparison, Lay Person) was:

• LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry): This is a highly sensitive and specific analytical chemistry technique used to precisely confirm the presence and concentration of drugs and their metabolites in urine samples. This serves as the objective, quantitative ground truth for drug concentrations.

8. Sample Size for the Training Set

The provided document describes performance studies (precision, method comparison, lay person study) for the Dochek® Multi-Drug Urine Test Cup devices. These are immunoassay devices, not machine learning or AI-based devices that typically have "training sets" in the computational sense. The document does not describe any such training set for an algorithm. The development of the immunoassay itself relies on chemical and biological principles rather than algorithm training.

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

Since there is no "training set" in the context of a machine learning algorithm for this immunoassay device, this question is not applicable. The device's performance characteristics are inherent to its biochemical design.

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Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device .
It is intended for prescription use. For in vitro diagnostic use only.
The test provides only preliminary results. 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. GC/MS or LC/MS is the recommended confirmatory method.
Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table.
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. 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. GC/MS or LC/MS is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. The test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed with two 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 performance characteristics and studies for the Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup, which are immunoassays for the qualitative determination of single or multiple drugs in human urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a single table with numerical targets, but rather implied by the results of the performance studies. The overall acceptance criterion is that the device is "substantially equivalent" to predicate devices, based on various performance characteristics.

For semi-quantitative interpretation, such as precision studies, the acceptance typically involves a high percentage of correct results (e.g., ≥95% or 100%) for samples at certain concentrations relative to the cutoff. For samples at the cutoff, some variability is expected.

For qualitative comparisons with a reference method (LC-MS/MS), accuracy metrics like sensitivity and specificity (or agreement) are generally used, especially for samples near the cutoff.

Here's a summary of reported performance, correlating with typical acceptance considerations for such devices:

• AMP 1000: All drug-free, low negative, and most near cutoff negative samples were correctly identified as negative. All high positive samples were correctly identified as positive. Some near cutoff positive and negative samples showed discordant results, as expected due to the nature of qualitative cut-off assays (e.g., Viewer A for AMP 1000: 17 negative results for "Near Cutoff Negative" LC-MS/MS, and 3 positive results for "Near Cutoff Positive" LC-MS/MS, with 3 positive results for "Near Cutoff Negative" LC-MS/MS and 0 negative for "Near Cutoff Positive" LC-MS/MS). The discordant results detail section confirms that most discrepancies occurred very close to the cutoff (e.g., AMP 1000, 1014.625 ng/mL LC/MS/MS result but device read negative). This pattern was consistent across all drugs, demonstrating that the device performs as expected around the stated cutoffs. |
  | Lay Person Study | High percentage of correct results when used by laypersons, demonstrating ease of use and interpretability of instructions and results for OTC use. | For both configurations (OTC), a high percentage of correct results was observed across all drugs and drug concentrations (from -100% cutoff to +75% cutoff). For samples significantly above or below the cutoff (e.g., -100%, -75%, -50%, +50%, +75% cutoff), the correct identification rate was consistently 100%. For samples at -25% and +25% cutoff, the correct results ranged from 90% to 100% (e.g., AMP 1000 at -25% cutoff: 95% correct, at +25% cutoff: 100% correct). All participants found the instructions easy to understand and follow, corroborated by a Flesch-Kincaid reading Grade Level of 7 for the package insert. |

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

• Precision Study:

  • Test Set Size: For each drug and each concentration (-100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, +100%), 50 tests were performed (2 runs per day for 25 days). Given there are 9 concentrations and multiple lots (3-6), this means hundreds of tests per drug. With 16 drugs, this amounts to a substantial number of individual tests.
  • Data Provenance: The study was "carried out for samples... by spiked target drug in drug-free urine samples." This indicates a prospective, controlled laboratory study using simulated clinical samples, likely conducted at the manufacturer's location in Guangzhou, China.

• Method Comparison Study:

  • Test Set Size: 80 "unaltered urine clinical samples" per drug (40 negative and 40 positive). With 16 drugs, this means 1280 clinical samples were tested.
  • Data Provenance: "in-house" study, using "unaltered urine clinical samples." The geographic origin of these clinical samples is not specified, but since the submitter is in Guangzhou, it's likely from China. It's a retrospective analysis of collected clinical samples, as they were "blind labeled" before testing.

• Lay Person Study:

  • Test Set Size:
    • Configuration 1: 78 male and 62 female participants (Total 140 participants). Each participant was given 1 blind-labeled sample. For each drug concentration (e.g., -100% cutoff to +75% cutoff), there were 20 samples tested (implying 20 participants per drug concentration level).
    • Configuration 2: 89 male and 51 female participants (Total 140 participants). Similar to Configuration 1, 20 samples were tested per drug concentration level.
  • Data Provenance: The study was conducted with participants from diverse educational and professional backgrounds, aged 21 to >50. The location is not explicitly stated but is implicitly tied to the manufacturer/clinical study site. The samples were "prepared at the following concentrations; -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens," then confirmed by LC-MS/MS and blind-labeled. This is a prospective study using simulated clinical samples.

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

• Ground Truth for Precision and Lay Person Studies: The ground truth was established by spiking known concentrations of target drugs into drug-free urine samples, and these concentrations were "confirmed by LC-MS/MS." This method uses an analytical standard as the ground truth. No human experts were used for establishing this type of ground truth, as it is based on precise laboratory measurements.

• Ground Truth for Method Comparison Study: The ground truth for the 80 "unaltered urine clinical samples" was established using LC-MS/MS results. LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly sensitive and specific analytical method and is considered the gold standard for confirmatory drug testing. Therefore, no human experts were needed to establish this ground truth; it's based on objective analytical data.

4. Adjudication Method for the Test Set

• Precision Study: No adjudication method mentioned as the results are quantitative counts of positive/negative for known concentrations.
• Method Comparison Study: The document lists results for three "Viewers" (A, B, C) who presumably interpreted the test cups. However, the final "Dochek Result" in the discordant table does not indicate an explicit adjudication between these viewers (e.g., 2 out of 3 agreement). Instead, it seems to imply the individual viewer's result that led to the discordance. For example, "Viewer A, B, C" indicates all three viewers had the same discordant result. "Viewer B, C" indicates these two had a discordant result, with Viewer A possibly having a concordant one. The data presented compares each viewer's result against the LC-MS/MS ground truth individually. There is no explicit mention of an adjudication process (e.g., 2+1, 3+1) for discrepant results among the viewers.
• Lay Person Study: Results are aggregated as counts of "Negative" and "Positive" for various concentrations. There's no mention of an adjudication method among laypersons for their individual interpretations, as each participant tested one blind-labeled sample. The study assesses the overall performance and ease of interpretation by individual lay users.

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

• No MRMC comparative effectiveness study was done. This device is a rapid immunoassay test cup, not an AI-powered diagnostic system requiring human interpretation with or without AI assistance. The "Viewers" in the method comparison study are likely laboratory personnel interpreting the test cup's visual lines, not "human readers" in the context of image interpretation with AI.

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

• Not applicable. This device is a manual immunoassay test cup, not an algorithm or software. It involves visual interpretation of control and test lines by a user.

7. The Type of Ground Truth Used

• For the precision studies and lay person studies, the ground truth was based on spiking known concentrations of drugs into drug-free urine samples, confirmed by LC-MS/MS. This is an analytical and laboratory-controlled ground truth.
• For the method comparison study, the ground truth was established by LC-MS/MS confirmation of "unaltered urine clinical samples." This is considered a gold standard analytical ground truth.

8. The Sample Size for the Training Set

• Not applicable. This device is an immunoassay test cup, not a machine learning or AI model that requires a training set.

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

• Not applicable, as this is not an AI/ML device requiring a training set.

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