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The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy 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. Each test 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.

This document provides details on the performance characteristics of the CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup. Since this is an in vitro diagnostic device (specifically, a drug screening test), the acceptance criteria and study design are typically focused on analytical performance (accuracy, precision, analytical specificity) rather than a multi-reader multi-case (MRMC) comparative effectiveness study, which is more common for imaging AI. Similarly, "human readers improving with AI vs without AI" is not applicable here as the device is the test, not an aid to human interpretation of another modality.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for qualitative drug screening tests like this is accurate detection around a specific cutoff concentration. The reported performance demonstrates the device's ability to correctly classify samples as positive or negative relative to these cutoffs.

Table of Acceptance Criteria and Reported Device Performance (Analytical Precision/Reproducibility)

The "Acceptance Criteria" column represents the desired performance for a qualitative assay around its cutoff. For positive results, this means detecting drug concentrations above the cutoff, and for negative results, it means not detecting concentrations below the cutoff. The provided precision data shows the number of positive (+) and negative (-) results out of 50 tests for various concentrations relative to the cutoff. An ideal performance would show 100% positive for concentrations above cutoff and 100% negative for concentrations below, with roughly 50/50 split at the cutoff itself (due to inherent variability).

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The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs above 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 or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. It is for in vitro diagnostic use only.

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 or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided FDA 510(k) Clearance Letter details the performance of the AssureTech Quick Cup Tests and AssureTech Multi-drug Urine Test Cup for qualitative and simultaneous detection of various drugs in human urine.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria:

1. Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices like these, acceptance criteria are typically related to the accuracy of the qualitative detection (positive vs. negative) compared to a gold standard, particularly around the established cutoff concentrations. The performance is assessed through analytical studies (precision, specificity, interference) and comparison studies with a confirmatory method.

Here's a table summarizing the implicit acceptance criteria based on the precision and lay-user studies, and the reported device performance. The acceptance criterion is inferred as the ideal performance for these types of tests, where results near or above the cutoff should be positive, and results significantly below should be negative. The performance data below is extracted from the "Precision" and "Lay-user study" sections.

Table of Acceptance Criteria and Reported Device Performance

Note: The precision study for AMP300, MET300, and TML100 used 3 lots, with "50-/0+" meaning 50 negative results and 0 positive results, and "50+/0-" meaning 50 positive results and 0 negative results. For the 'Cutoff' concentration, it shows a mix of positive and negative results, which is expected due to the nature of qualitative assays around the threshold.

2. Sample Sizes and Data Provenance

• Precision Study:

  • For AMP300, MET300, and TML100: Each drug had 8 concentrations (spanning -100% to +100% of cutoff, plus the cutoff). For each concentration, tests were performed two runs per day for 25 days, for 3 different lots.
    • This means 50 observations per concentration per lot (2 runs/day * 25 days/run).
    • Total observations per drug for all 3 lots: 8 concentrations * 50 observations/concentration * 3 lots = 1200 observations per drug.
  • Data for other drugs refer to previous 510(k) clearances (K243996, K201630, K181768, K180349, K170049, K161044, K153465, K152025, K151211).
  • Data Provenance: Retrospective, as samples were "prepared by spiking drug in negative samples" and confirmed by LC/MS. No specific country of origin is mentioned, but typically for FDA submissions, studies are conducted under GLP (Good Laboratory Practice) guidelines, often in the US or by international labs adhering to comparable standards.

• Comparison Studies (Clinical Samples):

  • For AMP300, MET300, and TML100: The tables show data broken down by "Negative" (presumably drug-free), "Low Negative" ( +50%). The sum of the positive and negative results across these categories for each operator represents the number of clinical samples tested for that drug.
    • AMP300: 5 (Negative) + 15 (LN) + 19 (NCN) + 24 (NCP) + 16 (HP) = 79 samples per operator. (Operator 1)
    • MET300: 4 (Negative) + 13 (LN) + 23 (NCN) + 20 (NCP) + 20 (HP) = 80 samples per operator. (Operator 1)
    • TML100: 2 (Negative) + 18 (LN) + 18 (NCN) + 19 (NCP) + 20 (HP) = 77 samples per operator. (Operator 1)
    • Total (approximate, as numbers vary slightly between operators): ~79+80+77 = ~236 clinical samples for AMP300, MET300, TML100 combined.
  • Data for other drugs refer to previous 510(k) clearances.
  • Data Provenance: Retrospective, using "unaltered clinical samples." No specific country of origin is mentioned.

• Lay-User Study:

  • Sample Size: 280 lay persons tested the device.
    • Configuration 1: 66 male + 74 female = 140 lay persons.
    • Configuration 2: 87 male + 53 female = 140 lay persons.
  • Data Provenance: Retrospective, samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." Confirmed by LC/MS. Conducted "at three intended user sites." No specific country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth (Clinical Samples)

• Ground Truth Establishment for Clinical Samples: LC/MS (Liquid Chromatography/Mass Spectrometry) is stated as the preferred confirmatory method and was used to confirm the concentrations of the samples. This is an objective chemical method, considered the gold standard for drug detection and quantification in urine.
• Experts: The comparison studies were performed "in-house with three laboratory assistants." While these individuals are performing the rapid tests, the ultimate ground truth is established by the LC/MS results. The "laboratory assistants" are not explicitly designated as "experts" in establishing ground truth, but rather as trained users of the device whose results are compared to the LC/MS gold standard.

4. Adjudication Method for the Test Set (Clinical Samples)

• The document states that "Operators ran unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results."
• There were three operators. The "Discordant Results" tables show discrepancies between the rapid test results and the LC/MS results, sometimes across multiple operators for the same sample.
• No explicit adjudication method (e.g., 2+1, 3+1) for the rapid test results themselves is described. The comparison seems to be a direct comparison of each operator's rapid test result against the LC/MS ground truth, and then discrepancies are noted. The LC/MS data serves as the final, objective ground truth.

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

• This document describes performance characteristics of an in-vitro diagnostic device (a qualitative urine drug test cup).
• No MRMC comparative effectiveness study was performed in the context of comparing human readers (e.g., radiologists interpreting images) with and without AI assistance. This type of study design is specific to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices in imaging, which is not applicable to a lateral flow immunoassay like the AssureTech Quick Cup Tests.

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

• Given this is a physical immunoassay test cup, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not directly apply in the same way it would for a software-based AI device.
• The "Comparison Studies" with laboratory assistants and the "Lay-user study" assess the device's performance when interpreted by human users. The device itself, by producing a visual result (line/no line), is the "algorithm." Its performance is inherently tied to human interpretation of that visual output. The precision and specificity studies represent the analytical performance of the device itself.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision, Specificity, pH/SG Effect): The ground truth was established by spiking known concentrations of drugs into negative urine samples, with concentrations confirmed by LC/MS.
• Comparison Studies (Clinical Samples): The ground truth was established by LC/MS results on unaltered clinical urine samples. LC/MS is a highly accurate chemical analytical method.
• Lay-User Study: Ground truth was established by spiking known concentrations of drugs into drug-free pooled urine specimens, confirmed by LC/MS.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for a traditional in-vitro diagnostic device (immunoassay). It does not mention any artificial intelligence (AI) or machine learning (ML) components that would typically require a "training set" in the computational sense.
• The terms "training set" and "test set" are common in AI/ML validation. For a traditional medical device, the studies described (precision, interference, specificity, comparison, lay-user) serve as the "validation set" against pre-defined performance criteria.
• Therefore, N/A for "training set" in the context of AI/ML.

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

• N/A (as above, no "training set" in the AI/ML context).
• However, if we consider how the device itself was developed, the ground truth for optimizing its performance (e.g., antibody binding, membrane characteristics) would have relied on highly controlled experiments with known concentrations of analytes, likely confirmed by advanced analytical chemistry methods like LC/MS. This process is part of the extensive R&D and quality control that precedes a 510(k) submission.

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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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The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, 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 cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive 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 Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs.

This drug test cup may contain any combination of the drug tests listed in the table above.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive 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.

Deepblue Home Muti-Drug Urine Test Cup and Deepblue Muti-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. Each test 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 provided FDA 510(k) clearance letter details the performance characteristics of the Deepblue Multi-Drug Urine Test Cup and Deepblue Home Multi-Drug Urine Test Cup. This information allows us to describe the acceptance criteria and the study that proves the device meets these criteria.

It's important to note that this device is a qualitative lateral flow immunoassay for initial drug screening, not a diagnostic imaging AI, so the criteria and study methodology differ significantly from those for an AI-powered diagnostic tool. Specifically, there are no references to AI assistance, human readers, or image adjudication, as these are not relevant to this type of device.

Acceptance Criteria and Device Performance for Deepblue Multi-Drug Urine Test Cups

The acceptance criteria for this type of qualitative immunoassay are primarily based on its analytical performance, specifically its ability to correctly identify the presence or absence of target drugs at specified cutoff concentrations. This is demonstrated through precision/reproducibility studies, analytical specificity (cross-reactivity and interference), and method comparison studies against a gold standard (LC-MS/MS).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the successful demonstration of performance in the analytical and method comparison studies. The goal is to achieve high agreement rates with the confirmatory method (LC-MS/MS) and consistent results at and around the cutoff concentrations.

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AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid 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 devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.

The provided document describes the analytical and user performance of the "AllTest Multi-Drug Rapid Urine Test Cup" and "AllTest Multi-Drug Urine Test Cup" for detecting various drugs in human urine.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or agreement. However, the performance studies demonstrate that the device is designed to correctly identify drug presence/absence relative to a defined cutoff concentration. For qualitative drug tests, a common expectation is high agreement rates for samples significantly above or below the cutoff, with some variability allowed for samples near the cutoff.

The reported device performance can be summarized from the precision and lay person studies. The precision studies show ideal performance at concentrations far from the cutoff (100% agreement), and expected variability (around 50% positive/negative calls) at the cutoff concentration. The lay person study similarly shows very high agreement (typically 90-100%) for samples adequately far from the cutoff concentration.

Since no explicit quantitative acceptance criteria are given in the provided text, the reported performance is presented in relation to the ideal behavior of a qualitative assay around its cutoff.

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The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocanabinol in human oral fluid. 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 insted analytes in anycombination, up to a maximum of 6 analytes. The tests provide only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test 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® Oral fluid Multi-Drug Test Kit (Cube) is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The LYHER® Oral fluid Multi-Drug Test Kit (Cube) device consists of a cube device, an oral fluid collection swab and a package insert.

The document describes the analytical performance studies for the LYHER® Oral fluid Multi-Drug Test Kit (Cube), a rapid lateral flow immunoassay. The device is designed to detect d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine, and Delta-9-Tetrahydrocannabinol in human oral fluid.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" as a pass/fail threshold for performance, but rather presents the results of precision-reproducibility studies across various concentrations relative to the cut-off. The performance is summarized by the number of positive and negative results at each concentration.

To construct a table of "acceptance criteria" (inferred as target performance, though not explicitly defined as such) and reported performance, we can focus on the precision-reproducibility studies around the cut-off and the comparison study data. For the comparison study, the implicit acceptance criterion is that the device accurately identifies samples as positive or negative relative to the LC/MS confirmation.

Inferred Acceptance Criteria (Conceptual) and Reported Device Performance

Note on Acceptance Criteria: The document provides raw performance data. For a qualitative immunoassay, the "acceptance criteria" are usually demonstrated by a high rate of negativity well below the cutoff, a high rate of positivity well above the cutoff, and a predictable transition zone around the cutoff concentration. The data presented supports this.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:

  • Precision-Reproducibility-Cut-Off Study: For each drug, 9 concentration levels were tested. For each concentration, there were 2 runs per day for 30 days, across 3 device lots, and by 3 operators.
    • This means 9 concentrations * 2 runs/day * 30 days * 3 lots * 3 operators = 4860 total tests per drug analyte for the precision study.
    • Each concentration within each operator/lot combination was tested 60 times (2 runs/day * 30 days). So for each specific concentration, lot, and operator, n=60.
  • Comparison Studies (Method Comparison):
    • Negative oral fluid: 360 samples (across all operators and sites for each drug).
    • Positive oral fluid at various ranges:
      • +50% cut off: For D-Amphetamine, 183 samples. For Cocaine, 186 samples. For d-Methamphetamine, 189 samples. For Morphine, 180 samples. For Phencyclidine, 192 samples. For Delta-9-Tetrahydrocannabinol, 195 samples.
    • The total number of samples for the comparison study for each drug is 360 (negatives) + (sum of the positive ranges for that drug). For example, for D-Amphetamine: 360 + 93 + 74 + 180 + 183 = 890 samples. This applies similarly to other drugs.

• Data Provenance: The document states "Method comparison studies for the LYHER Oral fluid Multi-Drug Test Kit(Cube) were performed at three testing sites with three operators at each site." The location of these sites is not explicitly mentioned (e.g., country of origin), but the submitter is based in China. The data origin is prospective as samples were prepared by spiking known concentrations into negative oral fluid for analytical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Ground Truth Establishment: The ground truth for the test set for both the precision and comparison studies was established by Laboratory Confirmed Concentrations, specifically using LC/MS (Liquid Chromatography/Mass Spectrometry). For the precision study, it states: "Each drug concentration was confirmed by LC/MS." For the method comparison studies, it states: "Operators tested the samples using the candidate device and the results were compared to LC/MS results."
• Number of Experts/Qualifications: LC/MS is a laboratory analytical method, not reliant on subjective expert interpretation like radiological imaging. Therefore, there were no "experts" in the sense of human annotators (e.g., radiologists) involved in establishing the ground truth via consensus or adjudication. The "experts" would be the qualified laboratory personnel performing and interpreting the LC/MS results, whose qualifications are implicit given the professional standards for such testing.

4. Adjudication method for the test set

• Since LC/MS is used to establish quantitative drug concentrations, and the device provides a qualitative "positive" or "negative" result based on a defined cutoff, there is no expert adjudication method (like 2+1, 3+1) mentioned or necessary. The device's result is compared directly to the LC/MS result relative to the established cut-off.

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 this device. This is a qualitative diagnostic test (immunoassay) for drug detection in oral fluid, not an AI-powered image analysis device that assists human readers. The "operators" mentioned are performing the test, not interpreting complex medical images.

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

• This device is a standalone test (a rapid lateral flow immunoassay), essentially an "algorithm only" in the sense that its chemical reactions produce a visual result (line presence/absence). Human interaction involves collecting the sample, applying it to the device, and visually interpreting the presence or absence of test lines. There isn't a separate "algorithm" that operates outside of the device itself to interpret the results. The performance data presented measures the device's inherent analytical accuracy against known concentrations and LC/MS.

7. The type of ground truth used

• The ground truth used for both precision and comparison studies was laboratory-confirmed drug concentrations via LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and quantitative analytical method, considered a gold standard for drug detection and quantification.

8. The sample size for the training set

• This device is a lateral flow immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance is based on the inherent chemical and biological properties of the reagents and test strip design. Therefore, the concept of a "training set" for model development is not applicable. The studies described are analytical validation studies, not AI model training.

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

• As explained in point 8, there is no "training set" for an AI model. The ground truth for the analytical validation (which is analogous to testing the device's inherent design performance) was established by LC/MS confirmation of spiked drug concentrations in oral fluid.

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AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of:

est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

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

Device Name: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the performance characteristics demonstrated in the studies, particularly the agreement/precision at and around the cutoff concentrations, and the specificity. Since this is an in vitro diagnostic (IVD) device, the "performance" here refers to its accuracy in detecting the target analytes and its overall reliability in a diagnostic context. This is fundamentally about how well the device matches a known, established ground truth.

• Agreement at -100%, -75%, -50% Cutoff: Generally 100% negative agreement.
• Agreement at +50%, +75% Cutoff: Generally 100% positive agreement.
• Agreement at -25% and +25% Cutoff: Ranged from 85.0% to 95.0% negative/positive agreement, respectively, demonstrating expected variability around the cutoff.
  All participants found the instructions easy to understand and follow (Flesch-Kincaid Grade Level 7). |

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

• Precision/Reproducibility Study:

  • Sample Size: For each drug and each concentration (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100% of cutoff), tests were performed in 2 runs per day for 25 days, using 3 lots of test cups. This means for each concentration and drug, there were 50 tests per lot (2 runs/day * 25 days) and 150 tests across 3 lots.
  • Data Provenance: Urine samples spiked with target drugs into drug-free urine. The drug concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study, not from actual patients.

• Analytical Specificity/Interference Study:

  • Sample Size: Not explicitly stated as a total number, but drugs and interfering compounds were spiked into drug-free urine samples and tested using 3 lots of devices for each interference condition.
  • Data Provenance: Laboratory prepared urine samples (drug-free urine spiked with various compounds).

• Method Comparison Study:

  • Sample Size: 80 unaltered urine clinical samples (40 negative and 40 positive) for each drug.
  • Data Provenance: Unaltered clinical urine samples. The country of origin is not specified but it is an in-house study.

• Lay Person Study:

  • Sample Size: 280 lay persons.
  • Data Provenance: Urine samples prepared by spiking drug(s) into drug-free pooled urine specimens. The concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study designed to evaluate user comprehension and ease of use, not true clinical performance with patient samples.

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

• Precision/Reproducibility, Analytical Specificity/Interference, Lay Person Study: Ground truth was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and standardized analytical method for drug concentration determination. No human experts were explicitly stated to establish this ground truth, as it's an objective chemical analysis.

• Method Comparison Study: Ground truth was established by LC-MS/MS. Similar to the above, this is an objective analytical method.

4. Adjudication Method for the Test Set

• For the Method Comparison Study, the device results were compared directly to the LC-MS/MS results. There is no mention of an adjudication process (e.g., 2+1, 3+1 expert review) for the ground truth itself, as LC-MS/MS is considered the definitive truth.
• For the Lay Person Study, the "ground truth" for the expected positive/negative call was based on the known spiked concentrations confirmed by LC-MS/MS. The participants' interpretations of the device results were then compared to this established truth. There was no adjudication of the lay person's reading, but rather an assessment of their accuracy against the known sample content.

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, an MRMC comparative effectiveness study was not done.
• This device is a qualitative lateral flow immunochromatographic assay ("rapid test cup") for in vitro diagnostic use, intended for direct reading by a user (either professionals or lay persons). It does not involve AI or human readers interpreting complex images or data assisted by AI.
• The closest analogy is the "Lay Person Study," which assesses how well lay users can interpret the results without assistance on complex outputs, but there is no AI component.

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

• Yes, in spirit, the analytical performance studies (precision, specificity, stability) and the LC-MS/MS ground truth in the method comparison study represent "standalone" performance. The device itself (the immunochromatographic strip) is the "algorithm," and its chemical reactions are assessed according to established scientific principles, independent of human interpretation prior to result line formation.
• However, the final reading of the lines on the rapid test cup is still a human-in-the-loop step, even for laboratory personnel in the precision and method comparison studies, and especially for lay users in their study. The intent of these "rapid test" types of devices is precisely for direct human interpretation.

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

• The primary ground truth used across all analytical and method comparison studies was LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and quantitative laboratory method used for definitive drug detection and concentration measurement.

8. The Sample Size for the Training Set

• This submission describes a premarket notification (510(k)) for an in vitro diagnostic device. Unlike AI/ML devices, these types of products typically do not involve "training sets" in the machine learning sense.
• The manufacturing process, antibody selection, and assay design for these immunochromatographic tests are developed and refined through internal R&D, often using a range of samples and iterations. The document does not describe a formal 'training set' analogous to those used for AI algorithms. The data presented are for validation and verification of the finished device.

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

• As noted above, a "training set" in the AI/ML context is not applicable here. The development of the reagents and test design would have relied on standard laboratory practices for developing highly specific and sensitive immunoassays, with positive and negative controls and calibration against known concentrations, usually verified by gold-standard analytical methods like LC-MS/MS.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

Notes on the tables below:

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

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

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

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

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

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

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

2. Sample Size and Data Provenance

Precision Study:

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

Method Comparison Study:

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

Lay Person Study:

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

3. Number of Experts and Qualifications for Ground Truth

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone Performance Study

Yes, standalone performance was conducted for the device.

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

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

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

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The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. 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 in vitro diagnostic use only.

The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. 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 in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP. Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the FDA 510(k) premarket notification for AssureTech Panel Dip Tests and Quick Cup Tests, which are in vitro diagnostic devices for qualitative and simultaneous detection of various drugs of abuse in human urine. The document focuses on demonstrating substantial equivalence to a predicate device (K181768).

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily related to its analytical performance, specifically its ability to accurately detect the presence or absence of target drugs at specified cutoff concentrations. The device is a qualitative test, meaning it provides a "positive" or "negative" result, rather than a quantitative measurement.

The study demonstrates performance through:

• Precision: Consistency of results across multiple runs and lots, especially near the cutoff concentrations.
• Specificity: Ability to react only with the target drug/metabolite and not with other substances or structurally similar compounds.
• Interference: Lack of false positives/negatives due to common interfering substances in urine, or variations in urine specific gravity and pH.
• Method Comparison: Agreement of device results with a known, more precise reference method (LC/MS).
• Lay-user study: Evaluation of the device's performance when used by non-professionals, assessing ease of use and accuracy of interpretation.

Here is a table summarizing the reported device performance for Fentanyl (FYL), Norfentanyl (NFYL), and as an example for another drug, Amphetamine (AMP) from the "Lay-user study" data. The document does not explicitly state numerical "acceptance criteria" for each performance metric, but rather presents the results of the studies conducted to show sufficient performance for regulatory clearance. The implicit acceptance criterion for a qualitative test like this is generally very high accuracy, especially around the cutoff, and a low rate of false positives/negatives.

Table of Performance for Key Drugs (Fentanyl, Norfentanyl, Amphetamine)

Precision Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
The precision data is presented for three lots and various concentrations relative to the cutoff. The data shows very high consistency. For instance, for Fentanyl:

• At -100%, -75%, -50% cut off (negative range), all 50 tests across 3 lots consistently yielded negative results (50-/0+).
• At +25%, +50%, +75%, +100% cut off (positive range), all 50 tests consistently yielded positive results (50+/0-).
• At the cutoff concentration, the device shows variability, as expected for tests near the decision threshold. For Fentanyl Panel Dip, results were 28+/22-, 29+/23-, 28+/22- for Lot 1, 2, 3 respectively (meaning some tests were positive and some negative at the cutoff). This variability is inherent for qualitative tests around the cutoff and implies that some samples at the cutoff may read positive and others negative, which is acceptable performance for a qualitative test. Similar patterns are observed for Quick Cup Fentanyl, Panel Dip Norfentanyl, and Quick Cup Norfentanyl.

Method Comparison Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
This study compared the device results against LC/MS, the preferred confirmatory method. The results are presented in tables showing agreement across different concentration ranges (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive).

Example for FYL (Fentanyl) - Panel Dip, Operator 1:

• Negative (LC/MS 0): Device: 0 Positive, 1 Negative (1 discordant result here, sample 1484, LC/MS 0.78 ng/mL, Device: +)
• Low Negative (LC/MS +50%): Device: 20 Positive, 0 Negative

Lay-User Study (Selected data for AMP, FYL, NFYL):
This study evaluates the percentage of correct results when used by lay persons at various concentrations relative to the cutoff.

Example for AMP (Amphetamine):

• Negative (100% below cutoff): 100% correct (0 positive, 20 negative)
• Low Negative (-75% to -25% Cutoff): 100% correct negative for -75% and -50%, but 0 positive/20 negative for -25% cutoff.
• Positive (+25% to +75% Cutoff): Generally high correctness (95%-100%). For +25% cutoff, 95% correctness (19 positive, 1 negative).

Detailed Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: For Fentanyl and Norfentanyl, the reported data is for 3 lots, with 2 runs per day for 25 days, for 9 concentrations (e.g., -100% cutoff, -75% cutoff, etc.). This implies 50 tests per concentration per lot (2 runs * 25 days), leading to 450 tests per drug type per lot (9 concentrations * 50 tests), and 1350 tests per drug type across all 3 lots. The data provenance implies these samples were prepared by spiking known concentrations of drug into negative samples, indicating a controlled laboratory environment. Data for other analytes was "reported in K181768" (the predicate device documentation), so the exact sample sizes are not explicitly stated in this document but are assumed to be similar.
   • Method Comparison Study: For Fentanyl and Norfentanyl, 80 unaltered clinical samples (40 negative and 40 positive based on LC/MS results) were used per drug. Each sample was tested by three laboratory assistants for each device type (Panel Dip and Quick Cup). This means 80 samples * 3 operators = 240 tests per drug for each device type. The data provenance is "in-house" and "unaltered clinical samples." The document does not specify the country of origin, but given the FDA submission, it's likely US-based or compliant with US standards. The study appears to be retrospective, using already collected clinical samples for comparison.
   • Lay-user Study: 280 lay persons were used for each device format (Panel Dip and Quick Cup, though the results summarized apply to the overall device type). Urine samples were prepared at 7 different concentrations (negative, +/-25%, +/-50%, +/-75%, +/-100% of cutoff). Each participant received one blind-labeled sample and one device. Assuming each person tested one sample, this implies 280 samples were tested for each specific drug evaluated by lay-users on each format. The data provenance: "samples were prepared by spiking drugs into drug-free pooled urine specimens" and confirmed by LC/MS. This is a controlled experimental set-up rather than real-world patient samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Precision Study: Ground truth was established by spiking known concentrations of drugs into negative samples and confirmed by LC/MS. No human experts were involved in establishing the ground truth directly for this part.
   • Method Comparison Study: The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is explicitly stated as the "preferred confirmatory method" and is considered a gold standard for drug detection and quantification in urine. No human expert readers established the ground truth; it was a laboratory instrument measurement. The study used three laboratory assistants to read the device results, but they were comparing their readings against the LC/MS truth, not establishing the truth themselves. Their qualifications are not specified beyond "laboratory assistants."
   • Lay-user Study: The ground truth was established by spiking known concentrations of drugs confirmed by LC/MS. No human experts established the ground truth of the samples. The study assessed the lay-users' ability to interpret the device results against this known truth.

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

   • Precision Study: No adjudication method mentioned as samples were prepared with known concentrations.
   • Method Comparison Study: No adjudication method was explicitly mentioned for the device results. Each of the three operators performed their own reads, and their individual results were compared to the LC/MS. Discordant results are noted for each operator.
   • Lay-user Study: No adjudication method was mentioned. Each lay user tested one sample against a pre-defined truth.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this report. This device is a rapid diagnostic test (lateral flow immunoassay), not an AI-assisted diagnostic tool for interpretation of medical images or other complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

   • This is a lateral flow immunoassay, which is a physical diagnostic device producing a visual result (colored lines). It does not involve an "algorithm" in the sense of a software-based AI or computational algorithm. The device itself is the "standalone" diagnostic. Its performance characteristics (precision, specificity, interference) are essentially its "algorithm only" performance. The method comparison study is akin to assessing the device's standalone performance against a gold standard. The lay-user study assesses human interpretation of the device's standalone output.

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

   • The primary ground truth for the analytical and method comparison studies was Liquid Chromatography-Mass Spectrometry (LC/MS), which is a highly accurate chemical method for detecting and quantifying substances.
   • For the precision and lay-user studies, the ground truth was based on spiked urine samples with known drug concentrations, which were then confirmed by LC/MS.

7. The sample size for the training set:

   • This document describes a 510(k) premarket notification for an in vitro diagnostic device (lateral flow immunoassay). Unlike AI/ML-driven devices that require extensive training data, such chemical-based devices are developed and optimized through chemical engineering and biological principles, not by "training" on datasets in the AI sense. Therefore, the concept of a "training set" with a statistical sample size as understood in machine learning is not applicable to this type of device. The development process involves chemical formulation and validation, not data training.

8. How the ground truth for the training set was established:

   • Since the concept of a "training set" as it pertains to AI/ML devices is not applicable, the establishment of ground truth for a training set is also not relevant in this context. The "ground truth" for the performance evaluation of the device relied on LC/MS results and carefully prepared spiked samples with known drug concentrations.

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