(104 days)
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:
| Study Type | Performance Metric | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Consistent qualitative results (positive or negative) across different lots and runs for samples at various percentages of the cutoff concentration. | For all drugs in the precision study, samples at +100%, +75%, +50%, and +25% cutoff consistently showed 0-/50+ (0 negative, 50 positive results) across all lots. Similarly, samples at -25%, -50%, -75%, and -100% cutoff consistently showed 50-/0+ (50 negative, 0 positive results) across all lots. For samples at the exact cutoff, there was a mix of positive and negative results, indicating appropriate assay performance around the cutoff (e.g., AMP 1000: 14-/36+, 13-/37+, 13-/37+ for lots I, II, III respectively). This demonstrates excellent reproducibility at concentrations sufficiently above and below the cutoff, with expected variability at the cutoff itself. |
| Analytical Specificity/Interference | Minimal cross-reactivity with non-target compounds and accurate results in the presence of various potentially interfering substances (e.g., pH, specific gravity). | The study provided detailed cross-reactivity percentages for a wide range of structurally similar and unrelated compounds. For many non-target compounds, results showed "Not detected" or very low cross-reactivity (e.g., l-Amphetamine: 2% for AMP 1000). For some compounds, higher cross-reactivity or even 100%+ was observed for related substances (e.g., Amobarbital: 3% for BAR 300, or Clonazepam: 20% for BZO 300), which is common in immunoassays and accounted for in the interpretation of preliminary results. Separately, the study found that pH levels of 4 to 9 and specific gravity levels of 1.003 to 1.035 did not affect assay results. |
| Method Comparison Study | High agreement with the reference method (LC-MS/MS) for both negative and positive samples, especially for samples further away from the cutoff. Minimal discordant results, with most discrepancies occurring near the cutoff concentration. | For each drug, 40 negative samples (including drug-free, low negative, and near cutoff negative) and 40 positive samples (including near cutoff positive and high positive) were tested. The tables show a high degree of concordance. For example: |
- 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
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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.
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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.
- Test Set Size:
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.
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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.
§ 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).