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The Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit-Qualitative is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to a Fentanyl test result, particularly when a preliminary positive result is obtained.

The Healgen® Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to detect test results from in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or point-of-care setting.

The AccuFluor Fentanyl FIA Test Kit-Qualitative is a rapid fluorescence immunoassay based on the principle of competitive binding, which uses fluorescent microspheres-labeled antibody as the indicator marker to qualitatively detect fentanyl in human urine. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1.0 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody coated fluorescence particles will then be captured by immobilized Fentanyl conjugate, and the signal will be detected in the test line (T) region to show a negative result. The signal will not be detected in the test line (T) region if the Fentanyl level exceeds 1.0 ng/mL because all the binding sites for the anti-Fentanyl antibodies will be saturated and the result will show as positive. To serve as a procedural control, a signal will be detected at the control line (C) region indicating the proper volume of specimen has been added and membrane wicking has occurred. The test is interpreted by the Healgen® Immunofluorescence analyzer OG-H180 and the result will be interpreted by the analyzer.

The provided FDA 510(k) clearance letter pertains to the Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative and the Healgen® Immunofluorescence Analyzer (OG-H180). This document outlines the general regulatory approval and provides some performance characteristics, but it is not a comprehensive study report detailing all aspects of the acceptance criteria and the full study that proves the device meets those criteria.

Specifically, the document does not explicitly state "acceptance criteria" as a defined set of metrics and thresholds prior to presenting performance data. Instead, it presents results from various analytical performance studies which are implicitly used to demonstrate equivalence to a predicate device. Similarly, it does not describe "human expert ground truth establishment," "adjudication methods," or "MRMC comparative effectiveness studies" because these are typically relevant for AI/ML-based diagnostic devices utilizing image interpretation or complex decision support, which is not the primary function described for this immunoassay and analyzer.

This device is an in vitro diagnostic (IVD) test for qualitative detection of fentanyl in urine, which relies on a chemical reaction read by an analyzer. Therefore, the "study" described is a series of analytical performance tests, rather than a clinical study with human readers and ground truth established by medical experts in the way that would be done for an AI radiology device, for example.

Despite these limitations in the provided text for certain categories, I will extract and infer information where possible based on the provided document and common IVD device clearance practices.

Acceptance Criteria and Device Performance for Healgen® AccuFluor Fentanyl FIA Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not explicitly list pre-defined "acceptance criteria" with specific numerical thresholds for all metrics. However, based on the provided performance data, here's an interpretation of the implied criteria and the reported performance. The "acceptance criteria" inferred here are based on what constitutes successful demonstration of performance for an IVD device of this type, often aiming for high accuracy, precision, and lack of interference, especially around the cutoff concentration.

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

• Analytical Precision: 60 replicates per concentration (6 replicates/day for 10 days) per lot, across 9 concentration levels, for 3 device lots. Total: 60 * 9 * 3 = 1620 individual tests.
• Interference: Samples with various interfering substances were tested, each at both drug-free and ±50% Cut-Off spiked fentanyl concentrations, using three batches of device. (Exact number of tests not specified, but implies a comprehensive set).
• Specificity: Various drug metabolites and other compounds tested, each using three batches of device. (Exact number of tests not specified).
• Effect of Urine Specific Gravity and pH: Samples across the specified ranges were tested at -50% and +50% Cut-Off levels by three different operators using three device lots. (Exact number of tests not specified).
• Method Comparison (Clinical Samples): 80 unaltered clinical samples (40 negative, 40 positive). These samples were run at three different testing sites.
• Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It does state they were "unaltered clinical samples," implying they were retrospective real-world samples collected from patients. It does not indicate if they were prospective.

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

• Not Applicable in the traditional sense for this device. For this IVD device, the primary ground truth for its performance studies (precision, specificity, method comparison) is established by analytical gold standards, specifically:
  • LC/MS-MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) for confirming fentanyl concentrations in precision studies and as the comparator method in the method comparison study.
  • This is a highly accurate and precise laboratory method for quantifying drug concentrations, and its results are considered the "ground truth" for chemical concentration data.
• There were "three different operators" for the specific gravity/pH study, but these are not "experts" in the sense of medical professionals establishing a clinical diagnosis ground truth. They are laboratory personnel performing the test.

4. Adjudication Method for the Test Set

• Not Applicable in the traditional sense. Given that the ground truth is established by LC-MS/MS, there is no human "adjudication" process like consensus reading by multiple radiologists for image interpretation. The LC-MS/MS results serve as the definitive reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on complex interpretation tasks) is not applicable to a qualitative immunoassay and analyzer like the Healgen AccuFluor Fentanyl FIA Test Kit, which determines the presence or absence of a substance based on a fluorescent signal. The device performance is assessed on its analytical accuracy against a gold standard method.

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

• Yes, the performance presented is primarily standalone. The Healgen® Immunofluorescence Analyzer (OG-H180) automatically interprets the fluorescent signal from the test kit. The performance data (precision, specificity, interference, method comparison) directly reflects the analytical capability of the device and test kit combination, without any human interpretation or intervention in the final "positive" or "negative" determination. A human loads the sample and the device performs the analysis and provides the result.

7. The Type of Ground Truth Used

• Analytical Gold Standard (LC-MS/MS): This is the primary method used to establish the true concentration of fentanyl in samples for precision studies and as the comparative reference for clinical samples.
• Spiked Samples: For analytical performance studies (precision, interference, specificity), known concentrations of fentanyl or interfering substances were added to negative urine samples, establishing a controlled ground truth.

8. The Sample Size for the Training Set

• Not explicitly stated in the document, and likely not applicable in the typical AI/ML sense. This device is an immunoassay, not an AI/ML diagnostic algorithm that undergoes a "training" phase with a large dataset. Immunoassays are based on biochemical principles and do not "learn" from data in the same way. Performance is optimized during development and validated analytically.

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

• Not Applicable / Not Described. As it's not an AI/ML device relying on a training set, the concept of establishing ground truth for training does not apply here. The analytical performance is characterized through rigorous testing under controlled conditions and comparison to established reference methods (like LC-MS/MS).

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The LZI Fentanyl III Enzyme Immunoassay is intended for the qualitative determination of fentanyl in human urine at the cutoff value of 1 ng/mL when calibrated against fentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Fentanyl III Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between the drug in the sample and the drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. The drug-labeled G6PDH conjugate is traceable to a commercially available fentanyl standard and referred to as fentanyl-labeled G6PDH conjugate. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of a drug in the sample, fentanyl-labeled G6PDH conjugate is bound to the antibody, and the enzyme activity is inhibited. On the other hand, when the free drug is present in the sample, the antibody would bind to the free drug; the unbound fentanyl-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Fentanyl III Enzyme Immunoassay is a kit comprised of two reagents, R1 and R2, which are bottled separately but sold together within the kit.

The R1 solution contains mouse monoclonal anti-fentanyl antibody, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with fentanyl in buffer with sodium azide (0.09%) as a preservative.

The provided FDA 510(k) Clearance Letter for the LZI Fentanyl III Enzyme Immunoassay details the device's acceptance criteria (in terms of performance characteristics) and the study results that demonstrate the device meets these criteria.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the satisfactory performance demonstrated in the various studies, aiming to prove substantial equivalence to the predicate device. The performance characteristics sections show the device meets the expected qualitative and quantitative accuracy, precision, and specificity.

• Negative by LC/MS analysis: 35 negatives, 0 positives by EIA.
• ** 50% above cutoff) by LC/MS:** 0 negatives, 61 positives by EIA.

Overall, 35/35 true negatives, 83/83 true positives (excluding near-cutoff positives and positives above cutoff). The remaining 32 discrepant samples (20 + 12) were positive by EIA but negative by LC/MS for fentanyl, indicating cross-reactivity with norfentanyl as a contributing factor. |
| Precision | Consistent and reliable qualitative results (positive/negative) across multiple runs and days, especially around the cutoff concentration. | Precision: 1 ng/mL Cutoff (N=88 total replicates over 22 days):

• 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL, 0.75 ng/mL: 88/88 Negative (100% agreement).
• 1 ng/mL (Cutoff): 4 Neg / 84 Pos (95.5% Positive, 4.5% Negative - demonstrating near-cutoff variability, which is expected for qualitative assays at the cutoff).
• 1.25 ng/mL, 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 88/88 Positive (100% agreement). |
  | Cross-Reactivity (Specificity) | Minimal or no false positives from structurally unrelated compounds. Acceptable cross-reactivity with fentanyl metabolites and structurally related compounds as defined by the assay's intended specificity. | Fentanyl and Metabolites: Fentanyl (100%), Norfentanyl (40%).
  Structurally Related Compounds: Varying levels of cross-reactivity (e.g., Acetyl fentanyl 25%, Acryl fentanyl 100%, Thiofentanyl 200%). Many substances showed "ND" (Not Detected) at high concentrations (e.g., 100,000 ng/mL).
  Structurally Unrelated Pharmacological Compounds: No interference (all Neg/Neg/Pos results for 0 ng/mL Fentanyl, -50% Cutoff, +50% Cutoff respectively) at 100,000 ng/mL for almost all listed compounds, except Dextromethorphan, which showed interference at 20,000 ng/mL (Neg/Pos/Pos) but was acceptable at 15,000 ng/mL (Neg/Neg/Pos). This demonstrates good specificity against common drugs. |
  | Interference | Test performance (positive/negative results) should not be significantly affected by common endogenous substances or preservatives found in urine, or by varying specific gravity and pH within physiological ranges. | Endogenous and Preservative Compound Interference: No interference observed for most compounds (e.g., Acetone, Ascorbic acid, Bilirubin, Glucose, Hemoglobin) at high concentrations (e.g., 100,000 mg/dL), showing Neg/Neg/Pos results for 0 ng/mL, -50% Cutoff, +50% Cutoff respectively. Boric acid showed interference at 1,000 mg/dL (Neg/Neg/Neg), indicating a potential issue if present at high concentrations. This is a known interference for certain urine assays.
  Specific Gravity Interference: No interference observed across the range of 1.000 to 1.030 (all Neg/Neg/Pos).
  pH Interference: No major interference observed between pH 3 to pH 11 (all Neg/Neg/Pos). |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Precision Study: 88 replicates for each concentration level (0 ng/mL to 2 ng/mL fentanyl).
  • Method Comparison (Clinical Samples): 150 unaltered clinical samples.
  • Cross-Reactivity: Duplicates for each compound and concentration tested.
  • Interference (Endogenous/Preservative): Duplicates for each compound and concentration tested.
  • Specific Gravity/pH Interference: Duplicates for each specific gravity/pH level and fentanyl concentration.
• Data Provenance:
  • The clinical samples for the Method Comparison study were obtained by LZI and "through collaboration with various clinical laboratories across the United States and Canada." This indicates a prospective and/or retrospective collection of real-world clinical samples from diverse geographical regions. The nature (retrospective/prospective) of the collection for these specific 150 samples isn't explicitly stated but "clinical samples" usually implies samples collected from patients.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth.
• Qualifications of Experts: Not explicitly stated. However, for LC/MS confirmation, it implicitly relies on the expertise of the laboratory personnel performing and interpreting the LC/MS (Liquid Chromatography-Mass Spectrometry) analysis, which is a gold standard for chemical identification and quantification. These would typically be trained analytical chemists or lab technicians with experience in mass spectrometry.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set in the typical sense of multiple human readers or reviewers resolving discrepancies.
• For the Method Comparison study, the "ground truth" was established independently by LC/MS. Discrepancies between the EIA result and the LC/MS result were reported and attributed to norfentanyl cross-reactivity. This is a comparison against a reference method, not a subjective adjudication by experts.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI algorithms where human interpretation is a primary component and AI aims to augment or replace it. This document describes an in vitro diagnostic (IVD) assay, an enzyme immunoassay, which is an automated lab test. Its performance is evaluated against a reference standard (LC/MS), not against human reader performance.

6. Standalone Performance

• Yes, standalone performance was done. The entire submission details the performance of the LZI Fentanyl III Enzyme Immunoassay as a standalone device. The qualitative accuracy, precision, cross-reactivity, and interference studies all evaluate the algorithm/device's performance independently in generating a preliminary analytical result from a urine sample. It does not involve human-in-the-loop performance; rather, it provides a result that a clinician then interprets in conjunction with other clinical data.

7. Type of Ground Truth Used

• The primary type of ground truth used for the quantitative confirmation of fentanyl concentration in the clinical samples (Method Comparison study) was LC/MS (Liquid Chromatography-Mass Spectrometry) analysis. This is considered a highly specific and sensitive reference method for drug quantification.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set. The described studies are verification and validation activities for a modified assay (Special 510(k) for an existing predicate device, LZI Fentanyl II). For IVD assays, "training" often refers to the internal development and optimization of the assay performed by the manufacturer, which precedes the formal V&V studies presented for regulatory submission. The reported studies are the test set performance.

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

• Since the training set size is not explicitly stated, the method for establishing ground truth for it is also not explicitly described. However, it is highly probable that internal development and optimization of the assay would have utilized similar rigorous analytical methods, likely LC/MS or other established analytical techniques, to calibrate and refine the assay's performance against known concentrations of fentanyl and its metabolites. This would be part of the manufacturer's design control and development process.

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BioSieve™ Fentanyl FIA Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ ToxiSmart FIA Reader.

It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.

BioSieve™ ToxiSmart FIA Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader can be used in a laboratory or in a point-of-care setting.

This test uses a lateral flow design with location-dependent lines and zones. BioSieve™ ToxiSmart FIA Reader scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad. Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the cutoff value, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigenantibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures fluorescence signal is weaker than the cutoff fluorescence signal. When the samples do not contain fentanyl antigen or levels below the cutoff value, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal is stronger than the cutoff fluorescence signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of goatanti-rabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BioSieve™ Fentanyl FIA Test Kit and BioSieve™ ToxiSmart FIA Reader.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a table format. However, the performance characteristics tested and summarized imply the criteria for acceptable performance. The study aims to demonstrate that the device performs as expected for a qualitative immunoassay for fentanyl in urine, particularly around the 1.0 ng/mL cutoff.

The reported device performance is presented in several sections:

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

• Precision Study Test Set: For each of 9 concentrations (e.g., -100% cutoff, cutoff, +100% cutoff), 6 runs per day for 10 days per device lot were performed. With 3 lots, this suggests: 9 concentrations * 6 tests/run * 10 days * 3 lots = 1620 individual tests (results reported as sums across these).
• Interference Study Test Set: Numerous interfering substances were tested with 3 batches of each device for drug-free urine and target fentanyl urine at -50% and +50% Cut-Off levels. The exact number of tests per substance is not specified, but it implies a substantial number.
• Specificity (Cross-Reactivity) Test Set: Various drug metabolites and opioid compounds were tested using three batches of device. The number of individual tests per compound is not explicitly stated.
• Effect of Urine Specific Gravity and pH Test Set: Urine samples across the specified ranges were spiked at -50% and +50% Cut-Off. Tested by three different operators per lot of device, with a total of three lots. The exact number of individual tests is not specified.
• Method Comparison Test Set: 80 unaltered clinical samples (40 negative and 40 positive based on an internal classification) were used per site across three different testing sites. This totals 240 clinical samples.
• Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "unaltered clinical samples" for the method comparison study, implying they were retrospective if they were already collected clinical samples. The precision study samples were "prepared by spiking fentanyl in negative samples," indicating these were artificially contrived samples, not naturally occurring clinical specimens, and were conducted in a controlled lab setting.

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

• For the Precision Study, "Each fentanyl concentration was confirmed by LC/MS-MS." LC/MS-MS (Liquid Chromatography/Mass Spectrometry) is a highly accurate analytical chemistry method, typically considered a gold standard for quantifying substances in biological samples. This method itself provides the "ground truth" and does not typically involve human "experts" in the sense of clinicians or radiologists reading results.
• For the Method Comparison Study, "The samples were blind labeled and compared to LC-MS/MS results." Again, LC-MS/MS is the ground truth. No human experts (e.g., radiologists) were used to establish the ground truth; it was established by an analytical instrument method.
• No information is provided about the qualifications of the operators who performed the tests on the BioSieve™ device at the three sites, nor is there mention of a panel of experts for subjective adjudication.

4. Adjudication Method for the Test Set

• None in the context of human expert adjudication. The ground truth for quantitative accuracy and comparative performance was established by LC-MS/MS, a definitive analytical method, not by human consensus or adjudication. The BioSieve™ device provides a qualitative result (positive/negative), which is then compared against the quantitative LC-MS/MS value relative to the 1.0 ng/mL cutoff.

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

• No, an MRMC study was not done. This device is a quantitative/qualitative immunoassay read by an instrument (BioSieve™ ToxiSmart FIA Reader), not interpreted by human readers in the same way an imaging AI would be. The "operators" in the method comparison study are likely technicians performing the test, not interpreting complex outputs. Therefore, a study on human reader improvement with AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in essence. The BioSieve™ ToxiSmart FIA Reader is an automated instrument that reads the test strip and displays results. The results presented for precision, interference, specificity, and comparison studies demonstrate the standalone performance of the BioSieve™ Fentanyl FIA Test Kit and the BioSieve™ ToxiSmart FIA Reader system. The device produces a qualitative result directly from the sample, without human interpretation of the signal beyond observing the final positive/negative display.

7. Type of Ground Truth Used

• LC-MS/MS (Liquid Chromatography/Mass Spectrometry): This highly accurate analytical method was used to confirm fentanyl concentrations in precision samples and as the reference method for clinical samples in the method comparison study. It provides objective, quantitative biochemical data, which is then translated to the qualitative positive/negative ground truth based on the 1.0 ng/mL cutoff.

8. Sample Size for the Training Set

• Not specified. The document describes performance validation studies for regulatory submission (510(k)). It does not provide details about a specific "training set" for an AI algorithm because the BioSieve™ ToxiSmart FIA Reader is not described as an AI-powered device in the typical sense of a deep learning model that requires a labeled training dataset. It's a fluorescence immunoassay reader. The "development modes" refer to how the test is run (Standard vs. Quick), not algorithmic training.

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

• Not applicable. As noted above, the device is an immunoassay system and reader, not explicitly an AI/machine learning algorithm requiring a training set with established ground truth in the context of typical AI development. The document describes analytical validation, not algorithmic training.

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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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The Rapid Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL.

The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Rapid Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL.

The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl at or above the cut-off concentration of 1 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

The provided document describes the Co-Innovation Biotech Co.,Ltd. Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard, which are rapid screening tests for the qualitative detection of Fentanyl (FYL) in human urine at a cut-off concentration of 1 ng/mL. The document includes performance data to demonstrate substantial equivalence to a predicate device (K220046 Superbio Fentanyl Urine Detection Kit).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for accuracy, sensitivity, or specificity. However, the precision study and accuracy study demonstrate performance relative to the cut-off concentration. The implied acceptance criteria are that the device should accurately detect fentanyl around the 1 ng/mL cut-off and exhibit minimal interference and cross-reactivity. The precision study illustrates the device's ability to classify samples correctly relative to the cut-off, and the accuracy study compares device results to LC/MS reference results.

• 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL: 100% negative (60/60 for each lot).
• 0.75 ng/mL (-25% cutoff): 4/60 (Lot 1), 4/60 (Lot 2), 2/60 (Lot 3) positive results (majority negative).
• 1 ng/mL (cutoff): 34/60 (Lot 1), 34/60 (Lot 2), 36/60 (Lot 3) positive results (near 50% positive/negative as expected at cutoff).
• 1.25 ng/mL (+25% cutoff): 56/60 (Lot 1), 58/60 (Lot 2), 56/60 (Lot 3) positive results (majority positive).
• 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 100% positive (60/60 for each lot).

Rapid Fentanyl (FYL) Test Dipcard:

• 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL: 100% negative (60/60 for each lot).
• 0.75 ng/mL (-25% cutoff): 4/60 (Lot 1), 2/60 (Lot 2), 6/60 (Lot 3) positive results (majority negative).
• 1 ng/mL (cutoff): 36/60 (Lot 1), 34/60 (Lot 2), 32/60 (Lot 3) positive results (near 50% positive/negative as expected at cutoff).
• 1.25 ng/mL (+25% cutoff): 54/60 (Lot 1), 56/60 (Lot 2), 56/60 (Lot 3) positive results (majority positive).
• 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 100% positive (60/60 for each lot). |
  | Accuracy (Agreement with Reference Method) | High agreement with a confirmed analytical method (LC/MS). | Rapid Fentanyl (FYL) Test Strip & Dipcard:
• Discordant results for both devices and all sites: One positive at 0.76 ng/mL (LC/MS result, below cutoff) and one negative at 1.04 ng/mL (LC/MS result, above cutoff).
• Drug-free: 27/27 negative calls by device.
• Less than half cutoff: 5/5 negative calls by device.
• Near Cutoff Negative (0.5-1 ng/mL): 7/8 negative calls by device, 1/8 positive call (at 0.76ng/mL).
• Near Cutoff Positive (1-1.5 ng/mL): 8/9 positive calls by device, 1/9 negative call (at 1.04ng/mL).
• High Positive (>1.5 ng/mL): 31/31 positive calls by device. |
  | Cross-reactivity | Minimal cross-reactivity with structurally similar compounds. | Fentanyl analogs showed varying degrees of cross-reactivity, some as low as 1.2 ng/mL (Acetyl fentanyl), while Norfentanyl and Acetyl norfentanyl showed very low (0.01%) cross-reactivity at 10,000 ng/mL. This indicates the device can detect some fentanyl analogs at relevant concentrations. |
  | Interference | No interference from common opioids, medications, or endogenous substances. | None of the tested opioids, commonly ingested medications, or substances (at specified concentrations) were shown to interfere with the test. |
  | Effect of urinary pH | Consistent results across a range of urinary pH. | Varying ranges of pH (3 to 9) did not interfere with performance. |
  | Effect of urinary specific gravity | Consistent results across a range of urinary specific gravity. | Varying ranges of urinary specific gravity (1.000 to 1.040) did not affect the test result. |

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

• Precision Study (Test Set):
  • Sample Size: 1620 observations in total (3 lots x 9 concentrations x 60 determinations/lot for each device type). Each concentration tested in 3 replicates daily for 10 non-consecutive days with 3 aliquots per location (2 operators per location, 3 locations).
  • Data Provenance: Drug-free human urine spiked with target fentanyl at various concentrations. The document does not specify the country of origin but implies laboratory-controlled samples, not patient data. Retrospective, as urine samples were collected and then spiked.
• Accuracy Study (Test Set):
  • Sample Size: 80 clinical urine specimens.
  • Data Provenance: Clinical urine specimens. The country of origin is not specified. Retrospective.

3. Number of Experts (or Reference Method) and Qualifications to Establish Ground Truth for the Test Set:

• Precision Study: Ground truth was established by precise spiking of fentanyl into drug-free urine at known concentrations, confirmed by LC/MS. No human experts were involved in establishing the ground truth for these spiked samples, as the concentration was analytically determined.
• Accuracy Study: Ground truth was established by LC/MS (Gas Chromatography/ Mass spectrometry or Liquid chromatography/Mass spectrometry) analysis of the clinical urine specimens. LC/MS is the "preferred confirmatory method" and considered the gold standard for quantitative drug testing. The qualifications of the LC/MS operators or analysts are not specified.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense of expert adjudication.

• In the precision study, known concentrations (LC/MS confirmed) served as the reference.
• In the accuracy study, LC/MS served as the reference method. Discordant results were analyzed by comparing the device's reading to the objective LC/MS concentration around the cutoff.

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

• No MRMC comparative effectiveness study was done in the context of human readers improving with AI vs. without AI assistance. This device is a rapid, screening test (immunochromatographic assay) and is not an AI-powered diagnostic imaging or interpretative device that augments human reader performance.
• However, the precision study did involve multiple operators (6 operators at 3 Point-of-Care sites) reading the results, although it wasn't designed as a comparative effectiveness study of human reader improvement. Each operator independently read the samples.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

• Yes, this device is a standalone test. The "Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl... The tests can be performed without the use of an instrument." The results are visually interpreted by a human operator, but the device itself does not involve an algorithm or AI. It functions as a direct chemical/immunological reaction.

7. Type of Ground Truth Used:

• Precision Study: Known concentrations of Fentanyl in urine, confirmed by LC/MS.
• Accuracy Study: Quantitative results from LC/MS analysis of clinical urine specimens.

8. Sample Size for the Training Set:

This information is typically not applicable or explicitly stated for rapid, immunoassay-based tests like the one described. These devices are developed through chemical and biological formulation and optimization rather than machine learning training on a "training set" of data. The document describes analytical validation studies, which are performance evaluations, not algorithm training.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of immunochromatographic device. The development process would involve optimizing reagent concentrations, membrane properties, and other manufacturing parameters to achieve the desired sensitivity and specificity, typically guided by analytical testing against known standards.

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Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:

Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug UrineTest Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

For over-the-counter use.

Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:

Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

For prescription use only.

The subject device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup. Multi-Drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Multi-Drug Urine Test devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The provided document is a 510(k) Summary for the Shanghai Accurature Diagnostics Co., Ltd. Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card. It describes the device's indications for use, its substantial equivalence to a predicate device, and performance data from various studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" for precision or agreement. However, it indicates a "qualified" result for percentage agreement among positives and negatives in the comparison study (Section 10.1). For precision (Section 10.7), it states a cutoff coincidence rate of 79% (which is >55%) and a ±25% cutoff coincidence rate of 88% (which is >84%), both deemed "qualified." For the lay user study, the percentages of agreement for specific concentrations are presented. Given that these devices are screening tools, the implicit acceptance criteria would be high agreement rates (ideally 100% or very close) for negative and strongly positive samples, and reasonable agreement around the cutoff concentrations.

Here's a summary of the reported performance from the comparison study, which appears to be the primary study for establishing initial performance characteristics:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Comparison Study (Section 10.1): The sample size is not explicitly stated as a single number. The tables show "agreement among positives" and "agreement among negatives" for each drug with percentages. While not directly stated, the implication is that a sufficient number of samples were tested to generate these percentages. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
• Precision Study (Section 10.7): For each drug, the study tested "drug free," "-75%Cut off," "-50%Cut off," "+100% cutoff," "+75%Cut off," and "+50%Cut off" samples. The number of samples per concentration is not explicitly given, but the results for "-75%Cut off," "-50%Cut off," "drug free" samples were all negative, and "+100% cutoff," "+75%Cut off," "+50%Cut off" samples were all positive. The specific number of samples at the cutoff and ±25% cutoff concentrations that led to the "79%(>55%)" and "88%(>84%)" coincidence rates, respectively, is not provided.
• Lay User Study (Section 10.8):
  • Test Cup: 603 laypersons. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff levels. Each layperson was given 1 blind-labeled sample.
  • Test Dip Card: 300 laypersons. Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff levels. Each layperson was given 1 blind-labeled sample.
  • Data Provenance: Not specified (e.g., country of origin or retrospective/prospective). However, the study involved "three intended user sites" and "diverse educational and professional backgrounds."

3. 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)

• Lay User Study (Section 10.8): The ground truth for the lay user study was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly reliable analytical chemical method. This is not dependent on human expert interpretation of the test results themselves, but rather on instrument analysis. The samples were "spiking drug free-pooled urine specimens" with known concentrations, and these concentrations were "confirmed by LC/MS." Therefore, the ground truth is analytical, not expert consensus on the device's outcome.
• For other studies like the Comparison Study and Precision, the method for establishing ground truth isn't explicitly detailed, but generally, for drug screening devices, analytical methods (like GC/MS or LC/MS) are considered the gold standard for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• No information on adjudication methods such as 2+1 or 3+1 is provided. The studies appear to rely on objective measures (percentages of agreement with an assumed or analytically confirmed truth). For the lay user study, the ground truth was analytical (LC/MS), eliminating the need for reader adjudication.

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

• This question is not applicable to the provided document. The device is a lateral flow immunochromatographic assay (a rapid drug test), not an AI-powered diagnostic system or an imaging modality that would involve human readers interpreting images. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. The device is a physical diagnostic kit (test cup/dip card) that provides a qualitative result (presence or absence of a line). It is not an algorithm, and its performance is inherently "standalone" in that it produces a result without further computational analysis. The "human-in-the-loop" aspect for this device involves a person performing the test and visually interpreting the lines, particularly in the over-the-counter (OTC) use case. The lay user study evaluates this "human-in-the-loop" performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The primary type of ground truth used, particularly for the lay user study, was analytical chemical confirmation, specifically LC/MS (Liquid Chromatography-Mass Spectrometry). For the precision study, samples were prepared at specific concentrations relative to the cutoff, implying a known, analytically verified concentration as the ground truth. This is considered a highly objective and accurate method for determining the presence and concentration of substances.

8. The sample size for the training set

• The document describes performance studies, cross-reactivity, interference, and a lay user study. It does not mention a "training set" in the context of machine learning or algorithm development. The device is a lateral flow immunoassay, which does not involve a training set as would be found in AI/ML applications. The studies described are for validation of the physical test device.

9. How the ground truth for the training set was established

• As there is no "training set" for this type of device, this question is not applicable. The underlying principles of the immunoassay are based on chemical reactions, not on data learned from a training set.

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The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.

Here's an analysis of the acceptance criteria and study details from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly defined by the performance observed in the precision and method comparison studies. The document states that for precision, all test results for samples at and below -25% of the cut-off were negative, and all results for samples at and above +25% of the cut-off were positive. This indicates the device accurately identifies samples substantially below and above the cut-off.

For the method comparison, the device's performance is presented through the concordance with GC/MS results, with discordant results explicitly listed. The overall performance is demonstrated by the number of samples correctly identified as negative or positive across various concentration ranges relative to the cut-off.

Since the document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or overall agreement percentage), the performance reported in the tables below represents how the device met the implied expectation of accurate qualitative detection around the cut-off.

• Samples at/above +25% cut-off: All Positive | - Samples at/below -25% cut-off: All Negative
• Samples at/above +25% cut-off: All Positive |
  | Method Comparison (Qualitative Performance around Cut-off) | | | |
  | AMP | 1000 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes:
• Negative Urine, +50% cut-off: 17 Pos, 0 Neg
  (Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
  | COC | 300 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes:
• Negative Urine, +50% cut-off: 5 Pos, 0 Neg
  (Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
  | MET | 1000 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes:
• Negative Urine, +50% cut-off: 16 Pos, 0 Neg
  (Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
  | OPI | 2000 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes:
• Negative Urine, +50% cut-off: 8 Pos, 0 Neg
  (Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
  | PCP | 25 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes:
• Negative Urine, +50% cut-off: 8 Pos, 0 Neg
  (Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |
  | THC | 50 | Concordance with GC/MS for negative, positive, and near-cut-off samples. | Cassettes:
• Negative Urine, +50% cut-off: 15 Pos, 0 Neg
  (Similar results for Dipcards & Cups with minor variations, see original tables for full detail.) |

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

The studies used unaltered clinical samples for the method comparison. The samples were collected and tested as follows for each analyte and device type (Cassette, Dipcard, Cup):

• AMP: 43 Negative urine samples, 0 samples +50% cut-off. (Total = 95 samples per operator/device)
• COC: 42 Negative urine samples, 0 samples +50% cut-off. (Total = 99 samples per operator/device)
• MET: 43 Negative urine samples, 0 samples +50% cut-off. (Total = 95 samples per operator/device)
• OPI: 45 Negative urine samples, 0 samples +50% cut-off. (Total = 96 samples per operator/device)
• PCP: 45 Negative urine samples, 2 samples +50% cut-off. (Total = 102 samples per operator/device)
• THC: 44 Negative urine samples, 4 samples +50% cut-off. (Total = 105 samples per operator/device)

The total number of unique samples is not directly reported, as these numbers represent the distribution of samples across different concentration ranges. Since "unaltered clinical samples" were used, this suggests they were retrospective in nature. The provenance (country of origin) of the data is not explicitly stated, but the applicant company is based in Hangzhou, China, suggesting the studies were likely performed there.

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

The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are "preferred confirmatory methods" as stated in the Indications for Use. The document does not specify the number of experts or their qualifications for operating these instruments or interpreting their results; it implies the use of standard laboratory practices for these confirmatory methods.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the test set results. The comparison is directly between the device's qualitative result (positive/negative) and the quantitative GC/MS or LC/MS result. Discordant results are noted but no further adjudication (e.g., by multiple experts reviewing the same case) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study evaluated the standalone performance of the device against a gold standard (GC/MS/LC/MS), not its effectiveness in assisting human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the studies conducted were standalone performance evaluations. The device (LYHER® Urine Multi-Drug Test Kit) is a rapid lateral flow immunoassay, which produces a visual result (line present or absent). The "operators" in the study simply interpret this visual result. The results presented are the device's performance as interpreted by an operator, not an AI algorithm. So, while it involves human interpretation of the device's output, it is a standalone performance of the device itself without additional AI assistance beyond the inherent design of the test kit.

7. The Type of Ground Truth Used

The ground truth used was quantitative analytical results from Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS). These are considered highly accurate confirmatory methods for drug detection and concentration.

8. The Sample Size for the Training Set

The document describes "Precision studies" involving spiking drugs into negative samples to achieve concentrations at various percentages around the cut-off. However, this is described as part of the analytical performance characterization and not as a "training set" for an algorithm. This device is a lateral flow immunoassay, not a machine learning or AI-based device, and therefore does not have a "training set" in the conventional sense of an AI model.

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

As this is not an AI/ML device, there isn't a "training set" that requires ground truth establishment. For the precision studies mentioned (which are part of analytical performance validation), the "ground truth" was established by spiking known concentrations of the target drug into negative urine samples. These spiked concentrations were then "confirmed by LC/MS" to ensure accuracy of the prepared samples.

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The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:

The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.

The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue® Drug Screen Fentany! / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only.

The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue® Drug Screen Fentany1 / Tramadol Cup Test detects and is calibrated against norfentany1, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated.

The test is not intended to differentiate between drugs of abuse and prescription use of Fentany/ Tramadol. The test is for in vitro diagnostic use only.

The Chemtrue® Multi-Panel Drug Screen Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentany, Marijuana, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Benzodiazepines, Antidepressants.

The Chemtrue® Multi-Panel Drug Screen Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Tricyclic Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Antidepressants.

The Chemtrue® Drug Screen Tests are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

The provided text describes the performance characteristics of the Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test and Dip Card Test. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay diagnostic devices typically involve high levels of agreement with a reference method, especially around the cutoff concentration. While explicit acceptance criteria ("Pass/Fail" thresholds) are not directly stated in the provided text, the reported performance demonstrates very high agreement.

Note: The tables below focus on the Fentanyl (FYL) and Tramadol (TML) tests as these are the new additions being evaluated in this submission. Previous analytes were cleared under older 510(k)s. The percentages under "Reported Device Performance" are calculated from the provided raw counts.

Method Comparison (Accuracy) Studies vs. LC/MS Reference Method

The agreement is calculated as (Number of correct results / Total number of samples in that category) * 100%.

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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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