(41 days)
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)
| Drug | Lot Number | Drug Concentration Categories (relative to Cutoff = 1 ng/mL) | Reported Performance (Negative/Positive) | Implied Acceptance Criteria |
|---|---|---|---|---|
| FTY | Lot I | +100%, +75%, +50%, +25% | 0-/50+ (100% Positive) | 100% Positive |
| Cutoff (1 ng/mL) | 12-/38+ (76% Positive) | High % Positive | ||
| -25%, -50%, -75% | 50-/0+ (100% Negative) | 100% Negative | ||
| -100% | 50-/0+ (100% Negative) | 100% Negative | ||
| FTY | Lot II | +100%, +75%, +50%, +25% | 0-/50+ (100% Positive) | 100% Positive |
| Cutoff (1 ng/mL) | 11-/39+ (78% Positive) | High % Positive | ||
| -25%, -50%, -75% | 50-/0+ (100% Negative) | 100% Negative | ||
| -100% | 50-/0+ (100% Negative) | 100% Negative | ||
| FTY | Lot III | +100%, +75%, +50%, +25% | 0-/50+ (100% Positive) | 100% Positive |
| Cutoff (1 ng/mL) | 11-/39+ (78% Positive) | High % Positive | ||
| -25%, -50%, -75% | 50-/0+ (100% Negative) | 100% Negative | ||
| -100% | 50-/0+ (100% Negative) | 100% Negative |
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.
| Drug | LC-MS/MS Result Category | Device Result | Viewer A | Viewer B | Viewer C | Implied Acceptance Criteria |
|---|---|---|---|---|---|---|
| FTY | Drug-Free ( +50% Cutoff) | + | 13 | 13 | 13 | |
| - | 0 | 0 | 0 |
Summary of Discordant Fentanyl Results (FTY 1 ng/mL):
| Drug | Operator | Sample ID | LC-MS/MS Result (ng/mL) | Dochek Result (Viewer) | Expected Result (based on Cutoff=1 ng/mL) | Discordance type |
|---|---|---|---|---|---|---|
| FTY | Viewer C | F046 | 0.945 | + | - | False Positive |
| FTY | Viewer A, B, C | F062 | 1.012 | - | + | False Negative |
| FTY | Viewer A, C | F083 | 1.020 | - | + | False Negative |
| FTY | Viewer B | F049 | 1.044 | - | + | False Negative |
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).
| Drug (Cutoff shown) | Results Category | Drug Concentration Categories (relative to Cutoff) | Reported Performance (% Correct Results) | Implied Acceptance Criteria (Typically ≥95% at +/-25% cutoff, 100% elsewhere) |
|---|---|---|---|---|
| AMP (1000 ng/mL) | Correct | -100%, -75%, -50%, -25% | 100% | 100% |
| +25%, +50%, +75% | 100% | 100% | ||
| BAR (300 ng/mL) | Correct | -100%, -75%, -50%, -25% | 100% | 100% |
| +25% | 95% | high % (e.g., ≥90%) | ||
| +50%, +75% | 100% | 100% | ||
| ... similar data for many drugs ... | ||||
| FTY (1 ng/mL) | Correct | -100%, -75%, -50% | 100% | 100% |
| -25% | 95% | high % (e.g., ≥90%) | ||
| +25%, +50%, +75% | 100% | 100% |
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.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).