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Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
Amphetamine (AMP) 1000 or 500 ng/mL
Secobarbital (BAR) 300 ng/mL
Buprenorphine (BUP) 10 ng/mL
Oxazepam (BZO) 300 ng/mL
Cocaine (COC) 300 or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Methamphetamine (MET) 1000 or 500 ng/mL
Morphine (MOP/OPI) 300 or 2000 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 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard 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 is the recommended confirmatory method.

Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
Amphetamine (AMP) 1000 or 500 ng/mL
Secobarbital (BAR) 300 ng/mL
Buprenorphine (BUP) 10 ng/mL
Oxazepam (BZO) 300 ng/mL
Cocaine (COC) 300 or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Methamphetamine (MET) 1000 or 500 ng/mL
Morphine (MOP/OPI) 300 or 2000 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 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard 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 Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard 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 singleuse 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.

Here's a breakdown of the acceptance criteria and study details for the Dochek® Multi-Drug Urine Test Dipcard, based on the provided FDA 510(k) summary:

This device is an in-vitro diagnostic test, not an AI/ML device, so many of the requested criteria (e.g., number of experts, adjudication, MRMC study, training set) typically apply to AI/ML software. Therefore, I will adapt the response to describe the data provided for this type of diagnostic device.

Acceptance Criteria and Device Performance for Dochek® Multi-Drug Urine Test Dipcard

This device is a qualitative immunoassay for the detection of various drugs in human urine. The acceptance criteria and performance are primarily based on its analytical accuracy (precision, specificity, and comparison to a gold standard) and usability.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of qualitative immunoassay, the primary acceptance criteria revolve around the device's ability to correctly classify samples as positive or negative at and around the specified cutoff concentrations. The "performance" is demonstrated through the observed concordance with confirmatory methods (LC-MS/MS) and its precision.

• AMP (1000 ng/mL): Lot I: 13-/37+, Lot II: 14-/36+, Lot III: 13-/37+ (out of 50 tests)
• BAR (300 ng/mL): Lot I: 14-/36+, Lot II: 12-/38+, Lot III: 14-/36+
• COC (300 ng/mL): Lot II: 13-/37+, Lot III: 12-/38+
• MDMA (500 ng/mL): Lot I: 10-/40+, Lot II: 10-/40+, Lot III: 11-/39+
  All samples ≥ +25% cutoff consistently showed "0-/50+" (0 negative, 50 positive). All samples ≤ -25% cutoff consistently showed "50-/0+" (50 negative, 0 positive). |
  | Analytical Specificity | Minimal or no cross-reactivity with structurally unrelated compounds at specified concentrations. Acceptable cross-reactivity with structurally related compounds. | Extensive cross-reactivity tables provided (pages 13-22 in original document) for all 16 drugs. Many structurally related compounds showed cross-reactivity, requiring careful interpretation of results (e.g., Amphetamine panel detects other amphetamine-like substances). Many non-structurally related compounds showed no interference at 100 µg/mL. |
  | Interference | Urinary pH (4-9) and Specific Gravity (1.000-1.035) should not affect results. Substances commonly found in urine should not interfere. | pH levels of 4-9 and specific gravity levels of 1.000-1.035 did not affect assay results. Over 100 non-structurally related compounds (e.g., acetaminophen, ibuprofen, glucose) showed no interference at 100 µg/mL. (Pages 22-23) |
  | Method Comparison (Accuracy) | High concordance with a confirmed analytical method (LC-MS/MS) for both negative and positive samples, especially around the cutoff concentrations. | High concordance with LC-MS/MS. For each drug, 80 clinical samples (40 negative, 40 positive) were tested. The detailed tables (pages 24-27) show the breakdown of positive/negative calls by the dipcard vs. LC-MS/MS concentrations (drug-free, low negative, near cutoff negative, near cutoff positive, high positive). While some discordant results (false positives/negatives near cutoff) were observed, they are typical for qualitative immunoassay screening tests designed to be highly sensitive around the cutoff. The device generally performed as expected for a qualitative screening test. |
  | Lay Person Usability | Lay users should be able to correctly interpret the device results and understand the instructions for use. | High (≥90%) correct result interpretation by lay users across various drug concentrations for the majority of tests. The "Percentage of correct results" for samples +/- 25% of cutoff varied (e.g., BAR 95%, BUP 90% for -25% cutoff; BUP 95% for +25% cutoff), indicating some variability by lay users near the cutoff, which is expected for visual interpretation of a qualitative test. All participants found the instructions easy to understand and follow, with a Flesch-Kincaid Grade Level of 7. (Pages 28-33) |
  | Stability | The device should demonstrate stability over its claimed shelf life. | Demonstrated stability at 2-30°C for 36 months based on real-time stability study. |

2. Sample Size and Data Provenance:

• Test Set Sample Sizes:
  • Precision/Reproducibility: For each drug and each of the three lots, 50 tests were performed at each of the 9 concentration levels around the cutoff (total of 450 tests per lot per drug for analytical precision). This was repeated for multiple lots.
  • Method Comparison: 80 clinical urine samples were used for each drug. These 80 samples consisted of 40 negative and 40 positive samples, further categorized by their concentration relative to the cutoff (drug-free, low negative, near cutoff negative, near cutoff positive, high positive).
  • Lay Person Study: 140 participants (79 male, 61 female for Configuration 1; 73 male, 67 female for Configuration 2). For each drug and concentration level, 20 samples were tested by lay users.
• Data Provenance: The document generally indicates "in-house" studies for method comparison and precision. The clinical samples for method comparison were "unaltered urine clinical samples." The lay person study used pooled urine specimens spiked with drugs, confirmed by LC-MS/MS. The country of origin for the data is implied to be China, given the manufacturer's address (Guangzhou, China). The studies appear to be prospective in nature as they involved preparing samples and testing them using the device under controlled conditions to evaluate performance.

3. Number of Experts and Qualifications for Ground Truth:

• This device is a qualitative immunoassay, not an AI/ML algorithm requiring expert interpretation of images. Therefore, the concept of "experts" to establish ground truth in the same way as for imaging AI is not directly applicable.
• The ground truth for the analytical studies was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate chemical method considered the gold standard for quantitative drug identification and concentration determination in urine.
• For the method comparison study, "three operators" performed the tests. Their qualifications are not explicitly stated, but for a laboratory-based study of an immunoassay, these would typically be trained laboratory personnel or technicians.

4. Adjudication Method for the Test Set:

• Not applicable in the context of an immunoassay device. The results are physical readouts (presence/absence of a line).
• For the Method Comparison study, the device result (positive/negative) was compared directly to the quantitative LC-MS/MS result. Discordant results are individually listed (pages 27-28), showing which operators, if any, had differing readings from the LC-MS/MS ground truth. Since three operators independently read the same samples for the method comparison, consistency among them can be inferred, but formal "adjudication" is not described as they were simply recording what they observed.

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

• No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is specifically designed for AI-assisted diagnostic tools (often in imaging) to compare human performance with and without AI assistance.
• This device is a standalone diagnostic test; it does not "assist" human readers in the interpretation of complex data (like medical images).

6. Standalone (Algorithm Only) Performance:

• Yes, in a sense. The "Performance Characteristics" section details the device's inherent analytical performance (precision, specificity, and method comparison against LC-MS/MS). These studies evaluate the device's ability to detect drugs independently of human interpretation nuances (though human "operators" did conduct the tests, the output is a visual line).
• The "Lay Person Study" then evaluates the human interpretation of the device's output.

7. Type of Ground Truth Used:

• The primary ground truth used throughout the studies (precision, method comparison) was GC/MS or LC/MS (Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Mass Spectrometry) results. These are highly accurate, quantitative analytical chemistry methods considered definitive for drug presence and concentration.
• For the lay person study, the "ground truth" for the samples was also established by LC-MS/MS confirmation of spiked drug concentrations.

8. Sample Size for the Training Set:

• This device is a chemical immunoassay, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development. The device's performance is inherent to its biochemical design.

9. How Ground Truth for Training Set was Established:

• As stated above, no training set for an algorithm exists for this type of device. The scientific and engineering principles of immunoassay design and manufacturing determine its performance, which is then validated through the analytical and clinical studies described.

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