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The LZI Methadone II Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay is 300 ng/mL for methadone. The assay is designed for prescription use on automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GCMS or LC/MS) or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (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 test result is positive.

The LZI Methadone II Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between methadone in the sample and methadone labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the methadone concentration in the sample is measured in terms of enzyme activity. In the absence of methadone in the sample, methadone-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free methadone is present in the sample, antibody would bind to free methadone; the unbound methadone-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 Methadone II Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

The Ri solution contains mouse monoclonal anti-methadone 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 methadone in buffer with sodium azide (0.09 %) as a preservative.

The LZI Methadone II Enzyme Immunoassay is an in-vitro diagnostic test for qualitative and semi-quantitative determination of methadone in human urine, with a cutoff of 300 ng/mL. The device's performance was evaluated through various studies demonstrating its precision, linearity, accuracy against LC/MS, cross-reactivity with other substances, and interference from endogenous compounds and pH levels.

Here is a summary of the acceptance criteria and reported device performance from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Studies (Qualitative & Semi-quantitative):
  • Within Run: 22 data points (2 replicates, 1 run/day for 22 days) for each concentration level (0 ng/mL, 75 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL, 450 ng/mL, 525 ng/mL, 600 ng/mL).
  • Total Precision: 88 data points (2 replicates, 2 runs/day for 22 days) for each concentration level.
  • Provenance: Samples were prepared by spiking a methadone standard into a pool of negative human urine. Therefore, this data is from controlled laboratory conditions, not directly from patients.
• Method Comparison - Clinical Samples (Accuracy Study):
  • Sample Size: A total of ninety-four (94) unaltered clinical samples.
  • Provenance: Samples were collected by Lin-Zhi International, Inc. (LZI) and from the University of California, San Francisco (UCSF). This indicates human clinical data.
• Linearity: Serially diluted methadone spiked urine, each run in 10 replicates for a range of 0 to 1000 ng/mL.
• Cross-reactivity and Endogenous Compound Interference: Various concentrations of each substance spiked into pooled negative human urine. (Not specified if replicates were performed for all, but for structurally unrelated compounds, it states "All samples were tested in replicates.")
• Specific Gravity and pH Interference: Urine samples (negative and spiked with methadone) adjusted to different specific gravity and pH levels respectively.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth.
For the accuracy studies with clinical samples, the ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an independent and highly sensitive analytical chemistry method. This method itself acts as the "gold standard" or "ground truth" for drug concentration determination, rather than relying on human expert interpretation of the test results.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for concentrations (precision, linearity, cross-reactivity, interference studies) was determined analytically. For clinical samples, the ground truth for methadone concentration was established by LC/MS, acting as an objective reference standard. No human adjudication process involving multiple readers is described for the test results.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic assay for chemical analysis, not an imaging device or AI diagnostic tool that typically involves human reader interpretation. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.

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

Yes, the studies presented are all standalone performance evaluations of the LZI Methadone II Enzyme Immunoassay device itself, without human interpretation in the results. The device outputs a quantitative or qualitative result, which is then compared against established ground truths (e.g., LC/MS, spiked concentrations).

7. The Type of Ground Truth Used

• For Precision, Linearity, Cross-reactivity, and Interference Studies: The ground truth was established by preparing urine samples with known, spiked concentrations of methadone or other compounds.
• For Method Comparison (Accuracy) with Clinical Samples: The ground truth for methadone and methadone metabolite concentrations was established using LC/MS (Liquid Chromatography/Mass Spectrometry).

8. The Sample Size for the Training Set

The document describes performance studies, which represent a test set. It does not mention a specific "training set" or "validation set" in the context of an algorithm or machine learning. For an immunoassay, the "training" typically refers to the assay development and optimization process, not a separate data set in the same way as an AI model.

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

As noted above, the concept of a "training set" for an algorithm with specific ground truth establishment is not directly applicable to this immunoassay device in the provided document. The development and optimization of the immunoassay (analogous to "training" in AI) would involve establishing reactivity to methadone and minimal cross-reactivity via laboratory experiments and chemical principles, rather than a distinct training data set with ground truth in the AI sense.

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The ARK EDDP Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of EDDP in human urine at cutoff concentrations of 100 ng/mL and 300 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.

The semiquantitative mode is for the purpose of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method, such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), or (2) permitting laboratories to establish quality control procedures.

The ARK EDDP Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed positive 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.

The ARK EDDP Assay is a homogeneous enzyme immunoassay technique used for the analysis of EDDP in human urine. The assay is based on competition between EDDP in the specimen and EDDP labeled with recombinant glucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. As the latter binds antibody, enzyme activity decreases. In the presence of EDDP from the specimen, enzyme activity increases and is directly related to the EDDP concentration. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme NAD functions only with the bacterial enzyme used in the assay.

The ARK EDDP Assay consists of reagents R1 anti-EDDP rabbit antibody with substrate and R2 EDDP derivative labeled with bacterial recombinant G6PDH enzyme.

Here's a breakdown of the acceptance criteria and study details for the ARK EDDP Assay, based on the provided FDA 510(k) summary:

This document describes a medical device, the ARK EDDP Assay, which is an immunoassay for the qualitative and/or semi-quantitative determination of EDDP (a methadone metabolite) in human urine. The study presented is a non-clinical performance evaluation, as indicated by "Brief Description of Nonclinical and Clinical Data" and the nature of the tests (Precision, Analytical Recovery, Analytical Specificity, Interference, etc.). No clinical study involving human patients or human readers in an MRMC setting is described.

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

The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with specific pass/fail values for each performance characteristic. Instead, performance is evaluated against expected behaviors for an in vitro diagnostic (IVD) device of this type. The inferred acceptance criteria are that the device should demonstrate acceptable precision, accurate analytical recovery, appropriate cross-reactivity and interference profiles, and good agreement with a gold standard (GC/MS) in method comparison for qualitative and semi-quantitative results.

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

• Precision Studies:
  • Target Concentrations: 9 levels for each cutoff (0.0 to 200.0 ng/mL for 100 ng/mL cutoff; 0.0 to 600.0 ng/mL for 300 ng/mL cutoff).
  • Replicates: Quaduplicate twice a day for 20 days.
  • Total Sample Size per Cutoff (for precision): 9 levels * 4 replicates * 2 (times/day) * 20 days = 1440 individual readings for the qualitative precision tables. (Note: The table summary states N=160 for each concentration level, implying 160 results for each of the 9 spiked levels.)
  • Data Provenance: Drug-free, negative human urine (spiked with EDDP). The country of origin is not specified but is likely the U.S. as it's an FDA submission. This is a prospective study (laboratory testing).
• Analytical Recovery:
  • Target Concentrations: 12 levels (50.0 to 1000.0 ng/mL).
  • Replicates: N=6 for mean concentration calculation.
  • Total Sample Size: 12 levels * 6 replicates = 72 individual readings.
  • Data Provenance: Drug-free, negative human urine (spiked with EDDP). Prospective laboratory testing.
• Analytical Specificity (Cross-reactivity):
  • Number of Compounds Tested: 7 structurally related compounds.
  • Sample Size: Each compound tested at minimum concentration for positive result (or highest tested) at both cutoff levels. Implies multiple tests per compound, but specific N is not given per compound; typically, this would be triplicate.
  • Data Provenance: Drug-free, negative human urine (spiked with compounds). Prospective laboratory testing.
• Interference (Structurally Unrelated, Endogenous Substances, Specific Gravity, pH):
  • Number of Compounds/Conditions Tested: Numerous (tens of compounds + SG and pH conditions).
  • Sample Size: Each compound/condition tested at two EDDP levels (±25% of cutoff). Implies multiple tests per condition, but specific N is not given per condition; typically, this would be triplicate.
  • Data Provenance: Drug-free, negative human urine (spiked with EDDP and interferent). Prospective laboratory testing.
• Method Comparison:
  • Sample Size: 109 unaltered clinical human urine specimens.
  • Data Provenance: "unaltered clinical human urine specimens that are not individually identifiable." Country of origin not specified, but usually implies local (US) clinical samples. Described as "clinical human urine specimens," suggesting these were collected from actual patients, making this a retrospective evaluation of real-world samples.

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

The ground truth for this diagnostic device is established by Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), which are highly accurate analytical chemistry techniques considered the gold standard for drug confirmation in urine. These methods are performed in laboratories by trained laboratory professionals (analytical chemists, toxicologists). The document states the GC/MS confirmatory method was performed by a "licensed reference laboratory."

• Number of experts: Not explicitly stated, as GC/MS analysis is a scientific measurement, not typically an "expert reader" interpretation process like image analysis. The "experts" are the qualified laboratory personnel operating and interpreting the GC/MS results.
• Qualifications of experts: Implied to be qualified laboratory professionals with expertise in analytical chemistry and toxicology, as they work in a "licensed reference laboratory." Specific certifications or experience years are not given.

4. Adjudication method for the test set

Not applicable. The ground truth is established by a definitive analytical method (GC/MS). There is no "adjudication" in the sense of reconciling disagreements among multiple human readers for an image-based or qualitative assessment. The GC/MS provides a quantitative concentration, which is then used to determine positive/negative relative to the cutoffs. Any "discordance" (like the one noted in the method comparison for Sample 51) is a direct comparison between the immunoassay result and the GC/MS result, not a result of human reader discrepancy requiring 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay designed to provide an automated analytical result (qualitative or semi-quantitative concentration of EDDP). It is not an imaging AI device that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Yes, the primary performance evaluation is standalone. The ARK EDDP Assay is an automated immunoassay performed on clinical chemistry analyzers. The results (qualitative positive/negative or semi-quantitative concentration) are generated by the assay system (reagents + analyzer) without human interpretive input for the result itself. The results are then reported to a clinician for medical interpretation in conjunction with other clinical information. The precision, analytical recovery, specificity, interference, and method comparison studies all represent the "algorithm only" or "device only" performance.

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

The ground truth used is definitive analytical method (Gas Chromatography/Mass Spectrometry - GC/MS). For in vitro diagnostic assays measuring specific chemical compounds, GC/MS is considered the most accurate and reliable "truth" method.

8. The sample size for the training set

This document does not specify a separate "training set" sample size. For an immunoassay like the ARK EDDP Assay, the "training" (development and optimization) phase would involve numerous laboratory experiments to select reagents, optimize assay conditions, and establish initial performance characteristics. This is distinct from machine learning model training sets. The studies presented (precision, analytical recovery, specificity, interference, method comparison) are performance validation studies for the final device, not datasets used to train an algorithm.

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

Not applicable in the context of an immunoassay. The "ground truth" for developing an immunoassay would be established by controlled spiking experiments using certified reference materials of the analyte (EDDP) in a known matrix (drug-free human urine), and confirming those concentrations using methods like GC/MS or LC-MS/MS, or by gravimetric/volumetric preparation. The goal is to ensure the assay accurately measures the target compound.

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The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GCMS or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (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 test result is positive.

The LZI Methadone Metabolite (EDDP) (100 and 300) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay at the cutoff values of 100 ng/mL and 300 ng/mL.

The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay is a homogeneous enzyme immunoassay with ready-to-use liquid reagents. The assay is based on competition between EDDP in the sample and EDDP labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the EDDP concentration in the sample is measured in terms of enzyme activity. In the absence of EDDP in the sample, EDDP-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free EDDP is present in the sample, antibody would bind to free EDDP; the unbound EDDP-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 Methadone Metabolite (EDDP) Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

The Ri solution contains mouse monoclonal anti-methadone metabolite antibody, glucose-6phosphate (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 methadone metabolite in buffer with sodium azide (0.09 %) as a preservative.

The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 100 ng/mL cutoff contain 0, 50, 75, 100, 125, 250, 500 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.

The LZI Methadone Metabolite (EDDP) Enzyme Immunoassay calibrators and controls designated for use at the 300 ng/mL cutoff contain 0, 150, 225, 300, 375, 600, and 1000 ng/mL of methadone metabolite (EDDP) in human urine with sodium azide (0.09 %) as a preservative. These five calibrators and two controls are sold as individual bottles.

The provided document is a 510(k) premarket notification for the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay and Calibrators. It focuses on demonstrating substantial equivalence to a predicate device, rather than establishing acceptance criteria and proving conformance to them in the same way a de novo or PMA submission might.

Therefore, the acceptance criteria are largely implied by the comparison to the predicate device and the analytical performance data presented. The study aims to show that the new device performs comparably to the predicate and provides accurate results for methadone metabolite detection.

Here's an attempt to extract the requested information based on the provided text, with notable limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Studies:

  • For each concentration level tested (e.g., 0, 25, 50, 75, 100, 125, 150, 175, 200 ng/mL for 100 ng/mL cutoff, and similarly for 300 ng/mL cutoff), there were N=22 samples for "Within Run" analysis and N=88 samples for "Total Precision" analysis. This suggests 4 runs (88/22).
  • Total number of unique samples for precision is not explicitly stated as distinct samples across all concentrations, but it's at least 9 concentrations x 22 samples for within-run and 9 concentrations x 88 for total precision for each cutoff. These are likely replicates of specific concentrations rather than 88 unique patient samples.
  • Data Provenance: Not specified (e.g., country of origin). Likely laboratory-prepared spiked samples for precision. Retrospective or Prospective is not stated but typically spiked samples are prepared for the study.

• Method Comparison - Clinical Samples:

  • 100 ng/mL Cutoff: N=87 clinical unaltered samples.
  • 300 ng/mL Cutoff: N=84 clinical unaltered samples.
  • Data Provenance: "clinical unaltered samples." Not specified (e.g., country of origin, retrospective or prospective), but implies real patient samples.

• Cross-reactivity: The sample sizes are implied by the "Spiked []" concentrations for each cross-reactant. Each cross-reactant was tested at a specific concentration. This is generally a set of controlled laboratory-prepared samples.

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

• Ground Truth Method: The primary ground truth for the clinical sample method comparison and for validating the calibrators/controls is Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS).
• Number/Qualifications of Experts: The document does not specify the number of experts or their qualifications involved in establishing the GC/MS or LC/MS ground truth. This is a common characteristic of device submissions where a recognized "gold standard" analytical method (like GC/MS or LC/MS for drug testing) is used, and the expertise is assumed to be inherent in the execution of that method by a qualified laboratory.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method involving multiple human readers or a formal adjudication process beyond using GC/MS/LC/MS as the confirmatory method. The presented data primarily compares the EIA results directly to LC/MS results. For the two discordant samples at the 100 ng/mL cutoff, their LC/MS concentrations are noted, but no further "adjudication" is detailed in the text beyond acknowledging the discrepancy.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the document. This type of study typically assesses human reader performance with and without AI assistance for tasks like image interpretation. This submission is for an in vitro diagnostic (IVD) immunoassay, not an AI-powered diagnostic imaging device.

6. Standalone Performance Study (Algorithm Only)

• Yes, this entire submission is essentially a standalone performance study of the "algorithm" (the LZI Methadone Metabolite (EDDP) Enzyme Immunoassay). The performance characteristics (precision, method comparison, cross-reactivity) demonstrate the device's analytical performance without human intervention in the interpretation of the raw assay signal, as it's designed for automated clinical chemistry analyzers. The "EIA Result" is the output of the device itself.

7. Type of Ground Truth Used

• The primary ground truth used is confirmatory analytical chemistry methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). These are considered highly accurate and specific "gold standards" for drug quantification.

8. Sample Size for the Training Set

• The document does not explicitly describe a "training set" in the context of an AI/machine learning model. This is an IVD device, where performance is established through analytical validation studies (precision, accuracy, interference, cross-reactivity) using predefined reagents and methods. The device's "algorithm" is the enzymatic reaction and spectrophotometric measurement, which is inherently deterministic, not a learned model in the AI sense.
• The calibrators are used for the calibration of the assay (0, 50, 100, 250, 500 ng/mL for 100 ng/mL cutoff; 0, 150, 300, 600, 1000 ng/mL for 300 ng/mL cutoff), which is analogous to "setting up" the device for accurate measurement.

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

• As there is no "training set" in the AI/ML context, this question is not directly applicable. For the calibrators, their concentrations are precisely defined (e.g., 100 ng/mL or 300 ng/mL of methadone metabolite (EDDP)). These are manufactured with known concentrations in a human urine matrix. The "ground truth" for calibrators is therefore their known, manufactured concentration.

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First Sign Drug of Abuse MDMA Tests are immunoassay tests. The test can detect MDMA in human urine. The cut-off value is 500 ng/mL.. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. If you want to get a confirmed result, you must use a more specific chemical method. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign Drug of Abuse EDDP Tests are immunoassay tests. The test can detect EDDP in human urine. The cut-off value is 300 ng/mL. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. If you want to get a confirmed result, you must use a more specific chemical method. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign Drug of Abuse Nortriptyline Tests are immunoassay tests. The test can detect Nortriptyline in human urine. The cut-off value is 1,000 ng/mL. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. If you want to get a confirmed result, you must use a more specific chemical method. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign™ Drug of Abuse MDMA Test, First Sign™ Drug of Abuse EDDP Test and First Sign™ Drug of Abuse Nortriptyline Test are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of MDMA, or EDDP or Nortriptyline in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of 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 performance characteristics of three drug of abuse tests: First Sign® Drug of Abuse MDMA Test, First Sign® Drug of Abuse EDDP Test, and First Sign® Drug of Abuse Nortriptyline Test. These are qualitative immunoassay tests designed to detect specific drugs in human urine.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria thresholds in terms of specific percentages for accuracy, sensitivity, or specificity. However, the performance is reported through various studies, and the implied acceptance criteria are that the device performs reliably at and around the defined cut-off values, and that lay users can operate the device effectively.

Below is a table summarizing the reported device performance, categorized by drug:

First Sign® Drug of Abuse MDMA Test

First Sign® Drug of Abuse EDDP Test

First Sign® Drug of Abuse Nortriptyline Test

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

• Precision Studies:

  • For each drug (MDMA, EDDP, Nortriptyline) and each format (Cup, Dip Card): 9 concentration levels (from -100% cut-off to +100% cut-off).
  • At each concentration level: 50 tests (2 runs/day for 25 days).
  • Total for precision per drug/format: 9 concentrations * 50 tests/concentration = 450 tests.
  • Total for precision across all 3 drugs and 2 formats: 3 * 2 * 450 = 2700 tests.
  • Data Provenance: "Prepared by spiking drug in negative urine samples." This suggests laboratory-controlled samples, likely from a US lab given the FDA submission. Retrospective, as samples were prepared and then tested.

• Cut-off Verification Studies:

  • For each drug and format: 4 concentration levels ( -50% cut-off, cut-off, +25% cut-off, +50% cut-off).
  • Total of 150 samples "equally distributed" meaning approximately 37-38 samples per concentration level. These were tested using three different lots.
  • Data Provenance: Laboratory-controlled samples, likely from a US lab. Retrospective.

• Interference and Specificity Studies:

  • The document implies that these were conducted with spiked samples in drug-free urine, testing against three lots of each device for all formats. No specific sample numbers are given for individual interference compounds or cross-reactants, but the method suggests a systematic laboratory study.
  • Data Provenance: Laboratory-controlled samples, likely from a US lab. Retrospective.

• Effect of Urine Specific Gravity and Urine pH:

  • Urine samples with varying specific gravity and pH were spiked with target drugs at 25% below and 25% above cut-off levels. Tested using three lots of each device for all formats. No specific sample number provided, but implies a comprehensive set to cover the specified ranges.
  • Data Provenance: Laboratory-controlled samples, likely from a US lab. Retrospective.

• Comparison Studies (Clinical Samples):

  • For each drug and each format: 80 unaltered clinical samples (40 negative, 40 positive).
  • Total for comparison studies across all 3 drugs and 2 formats: 3 * 2 * 80 = 480 clinical samples.
  • Data Provenance: "Unaltered clinical samples" implies real human urine samples from an unspecified source (likely US-based for FDA submission). The study is retrospective, as samples were collected and then tested.

• Lay-User Study:

  • For each drug: 280 lay persons.
  • Each participant tested one blind-labeled urine sample. There were 7 concentration levels tested (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off).
  • For each concentration and format (Dip Card / Cup): 20 samples.
  • Total samples given to lay users per drug: 7 concentrations * 20 samples/concentration * 2 formats = 280 samples. This matches the 280 lay persons.
  • Data Provenance: Laboratory-prepared urine samples (spiked drug into drug-free pooled urine). This is a prospective simulation of real-world use with prepared samples. The study was performed at "three intended user sites". Given the FDA submission, these are likely US sites.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Urine SG/pH Studies:

  • The ground truth (drug concentration) for all these studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted reference method for drug quantification in toxicology. The document does not specify a separate "expert" for interpreting GC/MS results, as the instrument provides quantitative values which are then used to prepare samples.

• Comparison Studies (Clinical Samples):

  • The ground truth for the 80 clinical samples per drug/format was established by GC/MS results.
  • The device results were interpreted by three different laboratory assistants. Their qualifications are not explicitly stated beyond "laboratory assistants," but it can be inferred they are trained professionals in a laboratory setting.

• Lay-User Study:

  • The ground truth for the prepared urine samples was established by GC/MS to confirm the spiked drug concentrations.
  • No "experts" were used to establish ground truth for how the lay users interpreted the test, as the study's purpose was to evaluate if lay users could correctly interpret the device results against the known (GC/MS confirmed) concentration.

4. Adjudication Method for the Test Set

• Precision Studies, Cut-off Verification, Interference, Specificity, Urine SG/pH Studies: The ground truth used was quantitative GC/MS results, which serves as a definitive reference standard. There's no indication of an adjudication process among multiple readers for these lab-controlled tests; the output of the device (positive/negative line) was compared directly to the GC/MS confirmed concentration.

• Comparison Studies (Clinical Samples): The document mentions "three different laboratory assistants" running the tests and comparing them to GC/MS results. It does not describe an adjudication method (like 2+1 or 3+1) among these three assistants where they would resolve discrepancies in their readings. Instead, individual discrepancies are noted in the "Discordant Results" tables for each viewer. This suggests independent assessment rather than a consensus-seeking or adjudicated process for the readers.

• Lay-User Study: Each lay user interpreted their own test result individually against the known GC/MS confirmed concentration. No adjudication among lay users was described.

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

• No, a typical MRMC comparative effectiveness study was not explicitly conducted as described for AI vs. human readers.
• The comparison studies did involve multiple readers (three laboratory assistants) reviewing clinical cases, which provides some multi-reader data. However, this was a standalone performance evaluation of the device being read by humans, not a comparison of human performance with vs. without AI assistance. The device itself is an immunoassay, not an AI algorithm providing assistance in interpreting complex images or data.
• Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone (Algorithm Only) Performance

• Yes, in essence, the "Analytical Performance" section (Precision, Cut-off, Interference, Specificity) represents the standalone performance of the devices. These studies evaluate the intrinsic performance of the immunoassay devices under controlled laboratory conditions, without human interpretation variability, by comparing the device's qualitative output (presence/absence of lines) against known, quantitatively confirmed drug concentrations.
• The "Comparison Studies" with laboratory assistants and "Lay-user studies" then evaluate the human-in-the-loop performance.

7. Type of Ground Truth Used

• All studies (Analytical, Comparison, Lay-User) consistently used Gas Chromatography/Mass Spectrometry (GC/MS) results as the gold standard ground truth.
• GC/MS is a laboratory-based, highly accurate, and quantitative method for identifying and measuring specific substances in a sample, making it a robust ground truth for drug testing.

8. Sample Size for the Training Set

• Not applicable. These are immunoassay devices (lateral flow tests), not machine learning or AI algorithms that require a "training set." The performance characteristics are derived from intrinsic chemical and physical properties, evaluated through these detailed analytical and clinical studies.

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

• Not applicable, as no training set was used.

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The AssureTech Buprenorphine Strip test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10ng/mL. This test is calibrated to Buprenorphine (calibrator). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.

The AssureTech Methadone Strip test is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 300ng/mL. This test is calibrated to Methadone (calibrator). The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. For in vitro diagnostic use only. The test is intended for over-the-counter and for prescription use.

The AssureTech Buprenorphine/Methadone Panel Dip test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech Buprenorphine/Methadone Quick Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL, and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech BuprenorphineMethadone Turn Key-Split Cup test is an immunochromatographic assay for the qualitative determination of Buprenorphine and Methadone in human urine at a Cut-Off concentration of 10ng/mL and 300 ng/mL, respectively. These tests are calibrated to Buprenorphine and Methadone (calibrators). The test may yield preliminary positive results when prescription drug Buprenorphine is ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Buprenorphine in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

The AssureTech Bunrenorphine Strip, AssureTech Methadone Strip, AssureTech Buprenorphine/Methadone Panel Dip, AssureTech Buprenorphine/Methadone Quick Cup and AssureTech Buprenorphine/Methadone Turn Key-Split Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Buprenorphine and/or Methadone (target analytes) in human urine. The Quick Cup format does not contain a turn-key for device activation. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The provided document is a 510(k) Premarket Notification for in vitro diagnostic devices designed to detect Buprenorphine and Methadone in human urine. It details the performance characteristics of these devices.

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

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The acceptance criteria are generally implied by the performance goals set for the device, particularly regarding concordance with GC/MS results and successful performance across various drug concentrations. The precision studies and comparison studies demonstrate the device's performance against these implicit criteria.

Note: The document doesn't explicitly state numeric "acceptance criteria" for accuracy (e.g., "must achieve 90% positive agreement with GC/MS at +25% cutoff"). Instead, the data is presented, and the conclusion states that the performance characteristics are "acceptable." We can infer the acceptance criteria from the observed performance and the nature of qualitative drug tests.

Here is a summary of the reported device performance from the "Precision" and "Comparison Studies" sections:

Precision Studies (Table Summarization):

• Test Setup: Samples at -100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% of the cut-off concentration. Confirmed by GC/MS. Blindly labeled. 2 runs per day for 25 days per device (total of 50 tests per concentration per lot). Three lots of each device were tested.
• Performance:
  • Buprenorphine: For all device types (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) across three lots:
    • All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ (50 negative, 0 positive) results.
    • All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- (50 positive, 0 negative) results.
    • Results at the "cut off" (0% cut-off, which should be 10 ng/mL) showed some variability, as expected for qualitative tests around the threshold. For example, for Buprenorphine Strip, Lot 1 showed 4-/46+ (4 negative, 46 positive) at cut-off, while Lot 2 showed 1-/49+. This indicates the ability to correctly identify samples near the cutoff, with some expected variation around the 50/50 mark.
  • Methadone: Similar trends were observed for Methadone across all device types and lots.
    • All true negative concentrations (-100% to -25% cut-off) consistently yielded 50-/0+ results.
    • All true positive concentrations (+25% to +100% cut-off) consistently yielded 50+/0- results.
    • Results at the "cut off" (0% cut-off, 300 ng/mL) showed variability, e.g., Methadone Strip, Lot 1 showed 2-/48+.

Comparison Studies with GC/MS (Table Summarization using a general view as specific numerical acceptance criteria like sensitivity/specificity are not given, but concordance is key):

• Setup: In-house study with 80 unaltered clinical samples (40 negative, 40 positive) per drug per device type. Operators ran blind-labeled samples. GC/MS was the reference method. Each device type (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup) was evaluated for both Buprenorphine and Methadone.
• General Performance (Across all device types for Buprenorphine and Methadone):
  • Negative Samples: Consistently showed 10 Negative (from true negative GC/MS) and 20 Low Negative (GC/MS < -50% cut-off) results.
  • Near Cutoff Negative: Showed 8 or 9 Negative results and 1 or 2 Positive results (e.g., Buprenorphine Strip, Viewer A, had 8 Negative, 2 Positive). This indicates some "false positives" or reads as positive for samples slightly below the cutoff.
  • Near Cutoff Positive: Showed mostly Positive results (13-15 positive, 0-2 negative). This indicates some "false negatives" or reads as negative for samples slightly above the cutoff.
  • High Positive: Consistently showed 25 Positive results.
• Discordant Results: The tables explicitly list the GC/MS result and the device's viewer result for discordant samples (those where the device's reading did not match the GC/MS result, usually near the cutoff). For instance, for Buprenorphine Strip, sample 11178 (GC/MS 9.8 ng/mL, cutoff 10 ng/mL) was read as Positive by Viewer A, while sample 31718 (GC/MS 10.9 ng/mL) was read as Negative by Viewer A. This highlights the inherent variability near the cutoff for qualitative assays.

Lay-User Study (Table Summarization):

• Setup: 1113 lay persons at three user sites. Urine samples prepared at -100%, -75%, -50%, -25%, +25%, +50%, +75% of the cut-off. Confirmed by GC/MS. Blind-labeled. Each participant received 1 sample and 1 device.
• Performance (Overall, aggregated results across all device types show good agreement):
  • Buprenorphine Strip (Example):
    • -100%, -75%, -50% cut-off: 100% correct negative results.
    • -25% cut-off: 95% correct negative results (1 positive out of 21).
    • +25%, +50%, +75% cut-off: 95-100% correct positive results. (e.g., +25% cutoff, 20+/1- for Buprenorphine Strip, 95% correct).
  • Methadone Strip (Example): Similar strong performance to Buprenorphine.
    • -100%, -75%, -50% cut-off: 100% correct negative results.
    • -25% cut-off: 95% correct negative results (1 positive out of 21).
    • +25%, +50%, +75% cut-off: 95-100% correct positive results. (e.g., +25% cutoff, 20+/1- for Methadone Strip, 95% correct).
  • Panel Dip/Turn-Key/Quick Cup: Similar high percentages of correct results, with slight variations around the -25% and +25% cut-off points, as observed in the Strip tests.

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

• Test Set (Precision Studies): For each drug (Buprenorphine, Methadone), for each device type (Strip, Panel Dip, Turn-Key Split Cup, Quick Cup), and for each of the 3 lots, samples were tested across 8 concentration levels. Each concentration was tested 50 times (2 runs/day for 25 days). So, for one drug and one device type, it's 3 lots * 8 concentrations * 50 tests = 1200 tests. Given there are 4 device types, this would be 4800 tests for Buprenorphine and similarly for Methadone.
• Test Set (Comparison Studies): For each device type (e.g., Buprenorphine Strip), 80 unaltered clinical samples (40 negative and 40 positive) were used. This was done for each drug (Buprenorphine, Methadone) and for each of the 4 device types. So total: 4 (device types) * 2 (drugs) * 80 (samples) = 640 clinical samples.
• Test Set (Lay-user study): 1113 lay persons participated. Urine samples were prepared at 7 concentration levels. Each participant was provided with one blind-labeled sample and one device. Assuming each person tested one sample, the sample size for this test is 1113 unique sample-device readings. However, the data presented in the tables for the lay-user study shows 21 samples per concentration level, for each drug and device type. This means multiple subjects tested samples from the same concentration group.
• Data Provenance:
  • Precision and Interference/Specificity/Cut-off Studies: Samples were "prepared by spiking drug in negative samples" which were confirmed by GC/MS. This suggests controlled laboratory samples.
  • Comparison Studies: "unaltered clinical samples." The document does not specify the country of origin of these clinical samples, nor does it explicitly state if they were retrospective or prospective, but the phrasing "unaltered clinical samples" suggests real-world specimens.
  • Lay-user study: "Urine samples were prepared... by spiking drug(s) into drug free-pooled urine specimens." Again, controlled laboratory samples, not clinical samples. Three "intended user sites" were used, but their location/country is not specified.

3. Number of Experts and Qualifications to Establish Ground Truth

• Precision/Prepared Samples: The ground truth for these samples was established chemically by GC/MS (Gas Chromatography/Mass Spectrometry), which is stated as the "preferred confirmatory method" and the method used to "confirm" sample concentrations. No human experts are explicitly mentioned for establishing ground truth for these spiked samples, as GC/MS is a quantitative analytical method providing objective chemical concentrations.
• Comparison Studies (Clinical Samples): The ground truth for the 80 unaltered clinical samples was also established by GC/MS.
• Lay-user Study: Ground truth for these prepared samples was established by GC/MS.
• Qualifications of Experts: The document states that the GC/MS confirmation was done. This method itself provides the "ground truth." While laboratory personnel would operate the GC/MS, their specific qualifications for establishing ground truth (like radiologists for imaging studies) are not pertinent in this chemical assay context.

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1, 3+1) is described for the test set.
• For the precision studies, results were observed ("50-/0+", "4-/46+", etc.) across multiple runs and lots.
• For the comparison studies, "three laboratory assistants" operated the device, and their results (labeled Viewer A, B, C) were directly compared to the GC/MS truth. There is no mention of these "viewers" adjudicating their readings or a consensus process. Discordant results are simply listed.
• For the lay-user study, lay persons read the device results. The comparison is between the lay person's reading and the GC/MS-confirmed concentration.

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

• No, an MRMC comparative effectiveness study was not performed in the traditional sense as described for AI vs. human assistance. This is a qualitative drug test, not an AI imaging device where human readers interpret cases and AI provides assistance.
• The "Comparison Studies" involved "three laboratory assistants" (analogous to multiple readers), who read the results of the device on clinical samples. Their readings were compared against GC/MS. This is a form of multi-reader study, but it's evaluating the device's performance when read by different individuals, rather than AI assisting human interpretation.
• Therefore, an "effect size of how much human readers improve with AI vs. without AI assistance" is not applicable or provided.

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

• This device is a rapid immunochromatographic assay (a "dipstick" type test), not a software algorithm. Therefore, the concept of a "standalone" algorithmic performance without human interpretation does not apply. The device produces a visual result (lines appearing or not appearing), which requires human observation to interpret.

7. The Type of Ground Truth Used

• The primary ground truth used throughout the studies is Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate and widely accepted analytical method for confirming the presence and concentration of substances, making it a robust 'gold standard' for drug testing.

8. The Sample Size for the Training Set

• This document describes performance characteristics for a rapid immunochromatographic assay, which is a chemical and biological test, not a machine learning model.
• Therefore, there is no "training set" in the context of an AI/ML algorithm. The device's performance is inherent to its physical and chemical design and manufacturing process.

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

• As there is no "training set" for an AI/ML model, this question is not applicable.

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The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with cutoffs of 100 ng/mL, 300n g/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. This assay is calibrated against EDDP. This in-vitro device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.

The Immunalysis EDDP Specific Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate 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 applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis EDDP Urine Calibrators
The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers.

Immunalysis EDDP Urine Control Sets
The Immunalysis EDDP Urine Control Sets are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant fab antibodies to EDDP. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes EDDP derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
2. All of the Immunalysis EDDP Calibrators and Controls are liquid and ready to use. These calibrators and controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte as a mixture.

The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2, and LOW Control 3 and HIGH Control 3 are prepared by spiking known concentrations of EDDP into the negative calibrator matrix. These five calibrators and six controls are sold as individual bottles.

The provided document describes the Immunalysis EDDP Specific Urine Enzyme Immunoassay, along with its calibrators and control sets, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For qualitative results, the acceptance criterion generally implies a high level of agreement with the confirmatory method, especially around the cutoff concentrations. For semi-quantitative results, similar high agreement is expected. Precision studies demonstrate the device's ability to consistently produce the same value. Specificity and interference studies aim to show that the device accurately identifies EDDP without significant false positives or negatives due to other compounds or physiological conditions.

Below is a table summarizing the reported device performance for the Qualitative and Semi-Quantitative Method Comparison studies, which are key to assessing acceptance criteria:

Table: Acceptance Criteria and Reported Device Performance (Method Comparison)

For Precision/Cutoff Characterization, the acceptance criteria are generally that samples below the cutoff are consistently negative and samples above the cutoff are consistently positive. Samples at the cutoff are expected to show a mix of positive and negative results, indicating the cutoff acts as a boundary. The device demonstrated this behavior across all cutoffs (100, 300, 1000 ng/mL) for both qualitative and semi-quantitative analysis. For example, at the 100 ng/mL cutoff, concentrations below 100 ng/mL yielded 80 negative results out of 80 determinations, while concentrations above 100 ng/mL yielded 80 positive results out of 80 determinations. At the 100 ng/mL cutoff itself, there were a mix of positive and negative results as expected (e.g., 43 Negative / 37 Positive for qualitative, 10 Negative / 70 Positive for semi-quantitative).

The specificity and interference studies showed that many structurally non-similar compounds up to high concentrations did not interfere with the assay. Some structurally similar compounds (e.g., Methadone, Chlorpromazine, Methylphenidate, Diphenhydramine, (±)-alpha methadol) did show cross-reactivity at high concentrations, and these are noted in the labeling. Boric Acid was identified as an interferent and limitations added to the labeling. pH and Specific Gravity within tested ranges did not interfere.

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

• Sample Size (Method Comparison):
  • For the 100 ng/mL cutoff: 80 unique clinical urine samples (40 positive by LC/MS and 40 negative by LC/MS). (Table 31)
  • For the 300 ng/mL cutoff: 80 unique clinical urine samples (40 positive by LC/MS and 40 negative by LC/MS). (Table 34)
  • For the 1000 ng/mL cutoff: 80 unique clinical urine samples (40 positive by LC/MS and 40 negative by LC/MS). (Table 36)
• Sample Size (Precision/Cutoff Characterization): For each cutoff (100, 300, 1000 ng/mL) and each concentration level relative to the cutoff (e.g., -100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%), there were 80 determinations (20 days, 2 runs per day, in duplicate). This results in 9 concentration levels * 80 determinations = 720 determinations per cutoff. This was done for qualitative and semi-quantitative modes.
• Data Provenance: The Method Comparison study used "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This indicates the data is retrospective and its country of origin is not explicitly stated but is implicitly from the US given the FDA submission. The other studies (Precision, Specificity, Interference, Linearity/Recovery) appear to use spiked or prepared samples, not directly from patients.

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

• The document does not mention the use of experts to establish ground truth for the test set.
• Instead, the ground truth for the method comparison study was established using a "more specific alternate chemical method," specifically Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS). These are analytical laboratory techniques, not human expert interpretation.

4. Adjudication Method for the Test Set

• Since the ground truth was established by LC/MS, there was no human adjudication process described for the test set results. The device's results were directly compared to the LC/MS confirmation.

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 an in-vitro diagnostic assay (an enzyme immunoassay) for the detection of EDDP in urine, not an AI-based image analysis or diagnostic tool that involves human readers interpreting results with or without AI assistance.

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

• Yes, the performance data presented is for the device operating in a standalone manner. The "Test Device" results were compared directly against the LC/MS confirmation. The assay is performed on automated clinical chemistry analyzers.

7. The Type of Ground Truth Used

• The primary ground truth used for performance verification (Method Comparison) was LC/MS (Liquid Chromatography/Tandem Mass Spectrometry) Confirmation. This is a highly accurate chemical analytical method considered the gold standard for drug confirmation.
• For other studies (Precision, Specificity, Interference, Linearity/Recovery), the ground truth was based on known concentrations of EDDP or other compounds in prepared urine matrices.

8. The Sample Size for the Training Set

• The document does not describe a "training set" in the context of machine learning or AI. This is a traditional immunoassay device. The assay development process involves optimization, but there isn't a "training set" in the way it's defined for AI/ML models. For traditional assays, development involves iterative testing and refinement of reagents and protocols using various samples, but this is distinct from training an algorithm.

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

• As mentioned above, there is no explicit "training set" in the AI/ML sense. The "ground truth" for the calibrators and controls used in the assay itself is established by spiking known concentrations of EDDP into a synthetic urine matrix and verifying these concentrations through mass spectrometry.

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First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.

The tests may yield preliminary positive results even when prescription drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Methadone, Phencyclidine, and Oxycodone in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards 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 text describes the performance characteristics and studies for the "First Sign® Drug of Abuse Cup Test" and "First Sign® Drug of Abuse Dip Card Test" for Methadone, Phencyclidine, and Oxycodone.

The acceptance criteria for each drug are implicitly defined by the reported performance, specifically in the precision, cut-off verification, and comparison studies. For instance, in the precision study, at -100% to -25% of the cut-off, all results were expected to be negative, and at +25% to +100% of the cut-off, all results were expected to be positive, with some allowance for variation at the exact cut-off concentration.

Here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a separate table. However, the performance tables demonstrate the device's adherence to the expected behavior around the cut-off concentrations. The "Precision" section's implied criteria are 100% correct negatives for concentrations below -25% of the cut-off, 100% correct positives for concentrations above +25% of the cut-off, and a high percentage of correct results at +/-25% and at the cut-off values. The "Cut-off" section verifies the stated cut-off values.

Table: Acceptance Criteria (Implied from Precision and Cut-off Studies) and Reported Device Performance

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

• Precision Study:
  • Sample Size: For each drug and each format (Dip Card/Cup), 8 concentrations were tested across 3 lots, with samples run 2 times per day for 25 days by 3 different operators. This is not a simple count of unique clinical samples. It uses spiked samples. Each individual concentration point (e.g., -100% cut-off) had 50 measurements (2 tests/day * 25 days by each of 3 lots, but the values are given as 50-/0+ or 50+/0- for each lot, suggesting 50 replicates per lot at each concentration).
  • Data Provenance: The samples were "prepared by spiking drug in negative samples." The document does not specify the country of origin, but the testing was conducted "in-house." These are prospective, laboratory-prepared samples.
• Cut-off Verification Study:
  • Sample Size: 150 samples ("equally distributed at concentrations of -50% cut-off; cut-off; +25% cut-off; +50% cut-off"). These were tested using three different lots of each device by three different operators.
  • Data Provenance: Similar to precision study, these were laboratory-prepared samples ("spiked drug in negative samples"). No country of origin is specified.
• Comparison Studies (Clinical Samples):
  • Sample Size: 80 "unaltered clinical samples" for each drug (40 negative and 40 positive). This means 80 samples for Methadone, 80 for Phencyclidine, and 80 for Oxycodone, for both Dip Card and Cup formats (though the tables suggest the same samples were likely used for both formats for a given viewer).
  • Data Provenance: "in-house" studies, using "unaltered clinical samples." The origin of these clinical samples is not specified (e.g., country, retrospective/prospective).
• Lay-user Study:
  • Sample Size: 280 lay persons for Methadone, 280 for Phencyclidine, and 280 for Oxycodone devices. Each participant received 1 blind-labeled sample. The samples themselves were prepared at 7 different concentrations, with 20 samples per concentration. This means a total of 140 samples for each drug (7 concentrations * 20 samples/concentration) were tested by the lay-users.
  • Data Provenance: "Urine samples were prepared... by spiking drugs into drug free-pooled urine specimens." The study was performed "at three intended user sites." No country of origin is specified. These are prospective, laboratory-prepared samples.

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)

• Precision, Cut-off, and Lay-user Studies (Spiked Samples): The ground truth was established by the precise spiking of drugs into negative urine samples at known concentrations, confirmed by GC/MS (Gas Chromatography/Mass Spectrometry). This is an analytical chemistry method, and implicitly, the expertise lies in the laboratory personnel conducting these precise preparations and GC/MS confirmations. No further expert qualifications are provided.
• Comparison Studies (Clinical Samples): The ground truth was established by GC/MS results for each of the 80 unaltered clinical samples per drug. No details on the number or qualifications of the GC/MS experts are provided, but GC/MS is the "preferred confirmatory method" for drug of abuse tests.

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

• Precision Study: "All sample aliquots were blind-labeled and randomized by the person who prepared samples and did not take part in the sample testing." Tests were performed by "three different operators." The results are aggregated, but no specific adjudication method among operators is explicitly described. It appears each operator's results were simply recorded.
• Cut-off Verification Study: Tested by "three different operators." Similar to precision study, results are aggregated, no specific adjudication is mentioned.
• Comparison Studies: "three different laboratory assistants" ("Viewer A, B, C") tested the samples. The tables show individual viewer results, followed by a list of "Discordant Results." This implies that there wasn't a formal adjudication method (like 2+1 or 3+1) in place to yield a single "device" result, but rather a comparison of each viewer's interpretation against the GC/MS ground truth.
• Lay-user Study: Each "participant was provided with the package insert, 1 blind labeled sample and a device." The results appear to be individual lay person interpretations compared to the GC/MS ground truth, with no inter-lay user 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

• No, an MRMC comparative effectiveness study involving AI assistance was not done.
• The studies involved human readers (laboratory assistants, lay-users) interpreting the device results, and these devices are immunochromatographic assays (lateral flow tests), not AI software. Therefore, there is no "AI vs without AI assistance" component to these studies.

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

• No, a standalone algorithm-only performance study was not done. The devices are physical tests interpreted by humans (either trained laboratory personnel or lay-users). They do not involve an algorithm separate from human interpretation.

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

• For all studies (Precision, Cut-off, Comparison, Lay-user), the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) of the spiked or clinical urine samples. GC/MS is a highly accurate analytical method considered the gold standard for confirming drug concentrations.

8. The sample size for the training set

• The document implies that these studies (precision, cut-off, comparison, lay-user) represent the validation of the device. It does not mention a separate "training set" in the context of machine learning or algorithm development, as this medical device is an immunoassay, not an AI/ML product. The development process for such a test would involve internal R&D and optimization, but the specific term "training set" as used in AI/ML is not applicable here.

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

• As a traditional immunoassay device, there is no "training set" in the AI/ML sense. The ground truth for the analytical and clinical performance studies was established using GC/MS of urine samples with known (spiked) or confirmed (clinical) drug concentrations.

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Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. 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.

Wondfo Morphine Urine Test (MOP 100) is an immunochromatographic assay for the qualitative determination of Morphine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. 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.

Immunochromatographic assays for Methadone and Morphine Urine Tests use a lateral flow, one step system for the qualitative detection of Methadone and Morphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

Here's a summary of the acceptance criteria and study details for the Wondfo Methadone Urine Test (MTD200) and Wondfo Morphine Urine Test (MOP100), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "sensitivity must be >X%"). Instead, the precision study demonstrates performance at various concentrations relative to the cut-off, and the comparison study evaluates agreement with GC/MS. The implied acceptance criteria are that the device should accurately classify samples at and above the cut-off as positive, and samples below the cut-off as negative, with high consistency.

Wondfo Methadone Urine Test (MTD200)

Wondfo Morphine Urine Test (MOP100)

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

• Precision Study Test Set:
  • For each drug (MTD200, MOP100) and format (Cup, Dip Card): 3 lots x 9 concentrations x 50 tests/concentration = 1350 tests per drug/format.
  • Total for Precision Study: 1350 (MTD Cup) + 1350 (MTD Dip) + 1350 (MOP Cup) + 1350 (MOP Dip) = 5400 tests.
  • Data Provenance: Samples were prepared by spiking drugs into negative samples. The document states "Each drug concentration was confirmed by GC/MS." Implies prospective preparation in a controlled lab setting, likely within China (country of origin of the submitter).
• Cut-off Verification Test Set:
  • Total of 150 samples per drug/format (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off).
  • Tested using three different lots of each device by three different operators.
  • Total for Cut-off Verification: 150 (MTD) + 150 (MOP) = 300 samples (at least for the reporting of performance, though the number of individual tests would be 150 samples * 3 lots * 3 operators = 1350 tests per drug if each operator tested each sample with each lot).
  • Data Provenance: Samples prepared by spiking drugs in negative samples, confirmed by GC/MS. Controlled lab setting.
• Interference Study Test Set:
  • For each interfering substance: spiked into drug-free urine and target drug urine (at 25% below and 25% above Cut-Off level).
  • Tested using three batches of each device for both Dip Card and Cup formats.
  • The exact number of samples (unique urine samples) is not stated, but the number of tests performed would be substantial given the long list of interfering substances.
  • Data Provenance: Controlled lab setting.
• Specificity (Cross-Reactivity) Test Set:
  • Tested "drug metabolites and other components that are likely to interfere."
  • Used three batches of each device for both Dip Card and Cup formats.
  • Data Provenance: Controlled lab setting.
• Effect of Urine Specific Gravity and Urine pH Test Set:
  • Urine samples with specific gravity 1.0001.035 or pH 49, spiked with target drugs at ±25% Cut-Off level.
  • Tested using three batches of each device for both Dip Card and Cup formats.
  • Number of samples not explicitly stated but implies a range of samples covering the specified SG and pH range.
  • Data Provenance: Controlled lab setting.
• Method Comparison Study Test Set:
  • 80 unaltered clinical samples per drug (40 negative and 40 positive).
  • Total for Method Comparison: 80 (MTD) + 80 (MOP) = 160 clinical samples.
  • Data Provenance: "unaltered clinical samples." The country of origin is not explicitly stated, but given the submitter's country, it is likely China. The study is retrospective as the samples were collected and then tested.

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

• For the Precision, Cut-off, Interference, Specificity, and Effect of SG/pH studies, the ground truth was established by GC/MS confirmation of spiked concentrations. This implies a skilled analytical chemist or laboratory technician performed these confirmations.
• For the Method Comparison Study, the ground truth was GC/MS results. "GC/MS is the preferred confirmatory method." The qualifications of the personnel performing the GC/MS are not specified beyond this.

4. Adjudication Method for the Test Set

• There is no explicit adjudication method described for the interpretation of the Wondfo device results in the method comparison study. The study states "Operators ran 80 ... clinical samples. The samples were blind labeled and compared to GC/MS results."
• There were three "laboratory assistants" (referred to as Viewer A, B, C) who presumably interpreted the Wondfo test results. Each viewer's results are reported individually, indicating no consensus or adjudication process among them for the device readings. The comparison is then made against the single GC/MS ground truth.

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 study is a comparison of a diagnostic device (Wondfo test kit) against a gold standard (GC/MS), interpreted visually by human "viewers" or "operators." It does not assess human reader improvement with or without AI assistance, as the device itself is a simple immunochromatographic assay, not an AI-based system.

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

• Yes, in effect, a standalone performance was demonstrated for the Wondfo device, with human interpretation being the "standalone algorithm" here. The "operators" or "viewers" simply read the device results. There is no complex human-in-the-loop interaction beyond visual interpretation of lines. The performance metrics presented (precision, specificity, comparison to GC/MS) reflect the device's inherent analytical characteristics when interpreted by a human, rather than the impact of an "algorithm only" in the sense of a machine learning model.

7. The Type of Ground Truth Used

• The primary ground truth used across all studies (Precision, Cut-off, Interference, Specificity, Effect of SG/pH, and Method Comparison) was the Gas Chromatography/Mass Spectrometry (GC/MS) results.
• For spiked samples, the concentration was also analytically confirmed by GC/MS.

8. The Sample Size for the Training Set

• This information is not applicable as the Wondfo Methadone/Morphine Urine Test is an immunochromatographic assay, not an AI or machine learning-driven device that requires an explicit training set. The manufacturing process and quality control for the test strips would be developed using internal data and R&D, but this is not typically referred to as a "training set" in the context of AI/ML.

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

• This information is not applicable for the reasons stated above (not an AI/ML device).

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The Randox Laboratories Ltd. Methadone Assay Is an in vitro diagnostic test for the qualitative and semiquantitative detection of Methadone in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for methadone. The Randox Methadone Assay has been developed for use on the seems analysers, which includes the day to name and the seemer ". This in vitro diagnostic device is intended for prescription use only.

The semi-quantitative mode is for purposes of

• (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
• or
• (2) permitting laboratories to establish quality control procedures.
  This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatographimass spectrometry (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 proliminary result is positive.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. for a Methadone Assay, Multidrug Calibrator Set, and Multidrug Controls. Unfortunately, the document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets them.

The document primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• The device's regulation number, product code, and regulatory class.
• General controls provisions of the Act that apply to the device.
• Contact information for various FDA offices.
• The Indications for Use statement for the Methadone Assay, Multidrug Calibrator Set, and Multidrug Controls.

Missing Information

The document does not provide the following crucial details needed to address the request:

1. A table of acceptance criteria and the reported device performance: This would typically include metrics like sensitivity, specificity, accuracy, precision, limit of detection, etc., along with the predefined targets for these metrics.
2. Sample size used for the test set and the data provenance: There is no mention of the clinical or analytical study design, the number of samples, or their origin.
3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is integral to understanding the validation process.
4. Adjudication method: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is more common for imaging diagnostics involving human interpretation, which is not the case for an in vitro diagnostic assay like this one. Therefore, it is highly unlikely such a study was performed or would be relevant.
6. Standalone performance (algorithm only without human-in-the-loop performance): While the device is an IVD assay and its performance would inherently be "standalone" in terms of measurement, the document does not present the data.
7. Type of ground truth used: For an IVD assay, ground truth is usually established by a reference method (e.g., GC/MS), but this is not explicitly detailed with performance data. The "Indications for Use" does state that GC/MS is the preferred confirmatory method, implying it would be used for confirmation if a preliminary positive result is obtained.
8. Sample size for the training set: Not applicable for this type of 510(k) submission unless an AI/ML component was specifically part of the device's analytical engine, which is not indicated. These are typically validated through analytical and clinical performance studies, not AI-style training and test sets in the same way.
9. How the ground truth for the training set was established: See point 8.

In summary, this document only confirms the FDA's clearance of the device based on substantial equivalence and specifies its intended use and regulatory classification. It does not contain the detailed validation study results or acceptance criteria. To obtain this information, one would typically need to refer to the full 510(k) submission document or the device's labeling (Instructions for Use or Package Insert) which would contain the performance data.

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The Randox Laboratories Ltd. Methadone Metabolite Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of 2-ethylidene-1,5-diphenylpyrrolidine (EDDP) in human urine. The cut off for both the qualitative and semi-quantitative modes of the assay is 300ng/ml for EDDP. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of EDDP use or overdose. The Randox Metabolite Assay has been developed for use on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.

The semi-quantitative mode is for purposes of

• (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
• or
• (2) permitting laboratories to establish quality control procedures.

This assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (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 Randox EDDP Calibrator Set consists of liquid calibrators containing EDDP. There are 5 levels of calibrator. They have been developed for use in the calibration of EDDP assays on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.

The Randox EDDP Controls, level 1 and 2 are liquid controls containing EDDP. There are 2 levels of controls. They have been developed for use in the quality control of the EDDP assay on the Rx series analysers, which includes the Rx Daytona and the Rx Imola. This in vitro diagnostic device is intended for prescription use only.

Not Found

The provided text is a 510(k) summary for the Randox Methadone Metabolite (EDDP) Assay, EDDP Calibrator Set, and EDDP Controls Level 1 & 2. It outlines the regulatory clearance of the device but does not contain a detailed description of the acceptance criteria nor a comprehensive study report with the specific information requested in your prompt.

Specifically, the text is a letter from the FDA informing Randox Laboratories, Ltd. that their device is substantially equivalent to legally marketed predicate devices. It states the indications for use, regulatory classification, and general controls provisions.

Therefore, I cannot provide the requested information based solely on the provided input. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Number/qualifications of experts, adjudication methods for ground truth, or details about the ground truth itself (pathology, outcomes data, etc.).
• Information on MRMC studies or standalone algorithm performance.

To obtain the information you're looking for, you would typically need to review the full 510(k) submission document or a more detailed study report.

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