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The Alinity o Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL (0.700 umol/L) on the Alinity c analyzer.

The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect benzodiazepines in human urine. This assay is calibrated against oxazepam. This product is intended to be used by trained professionals only.

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

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used 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 and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay with liquid ready to-use reagents. The assay uses a specific antibody that can detect most benzodiazepines and their metabolites in urine. The assay is based on competition between a drug labeled with glucose-6- phosphate dehydrogenase (G6PDH), and free sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the druq labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

Benzodiazepines are sedative-hypnotic drugs, which are subject to abuse. Benzodiazepines are include a wide variety of drugs such as alprazolam, diazepam, lorazepam, oxazepam, and triazolam. They are absorbed and metabolized at different rates, resulting in various psychoactive effects. Baselt describes the metabolism and toxicology of numerous benzodiazepines, including alprazeoam, chlordiazepoxide, clobazam, clorazepate, diazepan, estazolam, flunitrazepam, halazepam, medazepam, midazolam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, and triazolam.

The Alinity c Benzodiazepines Reagent Kit is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid for indicating Benzodiazeoine abuse through detection of benzodiazepines or their metabolites in urine

The document provided is a 510(k) Premarket Notification for an in vitro diagnostic device, the Alinity c Benzodiazepines Reagent Kit. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria for an AI model.

Therefore, many of the requested details regarding AI model acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set sample sizes for an AI study are not present in this document. This document describes the performance characteristics of a laboratory immunoassay, which is a chemical assay, not an AI or software algorithm that interprets images or complex data.

However, based on the provided text, I can extract the following information relevant to the device's analytical performance and its comparison to a predicate, which serves as a form of "acceptance criteria" for a diagnostic kit:

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

The document doesn't explicitly state "acceptance criteria" in a typical table format for an AI model's performance metrics (e.g., sensitivity, specificity, AUC with predefined thresholds). Instead, it describes the performance observed and compares it to a predicate device, often noting if they are "identical" or "substantially equivalent." The performance data presented are for specific analytical studies of the reagent kit.

Here's an attempt to structure the performance characteristics as reported, which act as the evidence for "acceptance" (i.e., substantial equivalence):

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

• Test Set Sample Size:

  • Accuracy and Method Comparison: The document states that the Alinity c Benzodiazepines Reagent Kit demonstrated "equivalent performance" when compared to LC-MS/MS, yielding "positive agreement was 100.00%, negative agreement was 96.96%, and overall agreement was 98.41%". While percentages are given, the absolute number of samples used for this accuracy study is not explicitly stated in the provided text.
  • Accuracy by Recovery and Dilution Linearity: A "series of samples" were analyzed, but the specific number is not stated.
  • Precision (Within-Laboratory and Reproducibility): The percentages of correctly read samples are given, but the underlying number of samples/tests performed is not explicitly stated.
  • On-Board Reagent Stability: "one lot" was used, but the number of tests or samples is not explicitly stated.

• Data Provenance (country of origin, retrospective/prospective): Not specified in the provided text.

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

This is not applicable as this is an in vitro diagnostic (IVD) chemical assay, not an AI product requiring expert review of medical images or data for ground truth. The ground truth for chemical assays is typically established by a reference method.

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

Not applicable, as this is an IVD chemical assay, not an AI product. Ground truth is established by a reference method.

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:

Not applicable, as this is an IVD chemical assay, not an AI product involving human readers.

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

The device (Alinity c Benzodiazepines Reagent Kit) is a standalone diagnostic test (specifically, an enzyme immunoassay) that provides results without human interpretation of raw assay data. The results (qualitative or semiquantitative determination of benzodiazepine presence) are generated by the Alinity c analyzer using the reagent kit. This is inherently a "standalone" analytical performance.

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

For the Accuracy and Method Comparison study, the reference method (ground truth) used was Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS). This is explicitly stated: "The Alinity c Benzodiazepines Reagent Kit demonstrated equivalent performance on the Alinity c analyzer when compared to the reference LC-MS/MS". The document also mentions GC/MS or LC-MS/MS as the "preferred confirmatory method" in the Indications for Use.

8. The sample size for the training set:

Not applicable. This is an IVD chemical assay; there is no "training set" in the context of machine learning model development. The assays are developed and validated using a different process than AI models.

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

Not applicable, as there is no training set for an AI model. For the chemical assay, "ground truth" for development and validation would involve well-characterized samples and reference methods like LC-MS/MS. The calibrators and controls for the assay are stated to contain Oxazepam and are traceable to a commercial source with 98% purity.

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Benzodiazepines II (BNZ2) is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on cobas c systems at cutoff concentrations of 100 ng/mL, and 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Semiquantitative assays are intended 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 coupled with Tandem Mass Spectrometry (LC-MS/MS).

Benzodiazepines II provides only a preliminary analytical test result. A more specific alternical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC-MS) or Liquid Chromatography coupled with 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.

The Benzodiazepines II assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/mL and 300 ng/mL. The semi quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The device consists of two wet reagents which contain the key components of the immunoassay: monoclonal/ polyclonal antibody against the drug, substrate, and enzyme-labeled drug (conjugate).

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

Acceptance Criteria and Device Performance for ONLINE DAT Benzodiazepines II

1. Table of Acceptance Criteria and Reported Device Performance

The direct "acceptance criteria" for performance are not explicitly listed in a single table, but rather demonstrated through various performance studies. The table below summarizes the key performance aspects tested and the results obtained for the ONLINE DAT Benzodiazepines II.

Device Name: ONLINE DAT Benzodiazepines II
Intended Use: Qualitative and semiquantitative detection of benzodiazepines in human urine on cobas c systems at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL.

Study Details:

2. Sample Size used for the test set and the data provenance:

   • Precision Study: 84 determinants (n=84) for each cutoff concentration (100, 200, 300 ng/mL) in both qualitative and semi-quantitative modes. These samples were drug-free negative urine spiked with Oxazepam. Data provenance is internal to Roche Diagnostics, as samples were prepared for the study.
   • Analytical Recovery and Linearity Study: 17 levels per cutoff, run in triplicate, for three reagent lots. Samples were "prepared" (implied internal spiking/dilution).
   • Analytical Specificity/Cross-Reactivity Study: Concentration series prepared for each cross-reactant by spiking drug-free urine. Data provenance is internal.
   • Endogenous Interferences: Two sets of samples per interferent, containing benzodiazepine and/or glucuronidated benzodiazepine. Data provenance is internal.
   • Interference Drugs: Samples spiked with benzodiazepine in the presence of potentially interfering drugs. Data provenance is internal.
   • Specific Gravity and pH Interference: Urine samples prepared with varying pH and specific gravities, spiked with benzodiazepine. Data provenance is internal.
   • Method Comparison (Clinical Correlation) Study:
     • 100 ng/mL Cutoff: 137 native human unaltered samples in total (48 screened negative, 54 screened preliminary positive/confirmed, 8 near cutoff negative by LC-MS/MS, 7 near cutoff positive by LC-MS/MS).
     • 200 ng/mL Cutoff: 134 native human unaltered samples in total (56 screened negative, 57 screened preliminary positive/confirmed, 12 near cutoff negative by LC-MS/MS, 9 near cutoff positive by LC-MS/MS).
     • 300 ng/mL Cutoff: 114 native human unaltered samples in total (40 screened negative, 45 screened preliminary positive/confirmed, 17 near cutoff negative by LC-MS/MS, 12 near cutoff positive by LC-MS/MS).
     • Data Provenance: Samples were "purchased from clinical laboratories" and "obtained from a clinical laboratory," implying a retrospective collection of clinical urine samples from the United States or a jurisdiction with similar clinical laboratory practices.
   • Stability Study: Two control samples per cutoff, the cutoff calibrator, and two clinical samples (pooled urine from individual donors). Data provenance is internal.

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

   • No human experts were explicitly used to establish a ground truth in the sense of clinical interpretation for this in vitro diagnostic device study.
   • The "ground truth" for the method comparison study was established by a confirmatory analytical method: Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS), which is considered the gold standard for drug confirmation. This is an objective analytical measurement, not an expert opinion.
   • For the precision, linearity, and interference studies, the ground truth was based on precisely prepared spiked samples with known concentrations.

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

   • There was no adjudication method described for the test set in the conventional sense of expert review for image-based diagnostics.
   • The method comparison data used LC-MS/MS as the reference method. Discrepant samples in the method comparison were cross-referenced against the LC-MS/MS values, which served as the definitive reference.

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 performed or described. This device is an in vitro diagnostic (IVD) immunoassay for detecting substances in urine. It does not involve human readers interpreting images with or without AI assistance. Therefore, this question is not applicable.

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

   • Yes, the primary performance evaluation is a standalone (algorithm only) performance. The device itself is an automated chemical analyzer (cobas c systems) that performs the immunoassay and generates a result (qualitative or semi-quantitative concentration). There is no "human-in-the-loop" performance component for the direct operation or result generation of the device. The results are then used by clinical laboratories.

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

   • For the method comparison study, the primary ground truth was Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS), which is an objective chemical confirmatory method.
   • For other analytical performance studies (precision, linearity, cross-reactivity, interferences, stability), the ground truth was based on known concentrations in spiked samples prepared in the laboratory.

8. The sample size for the training set:

   • The document describes performance evaluation studies (validation studies) for a cleared device. It does not explicitly mention a "training set" or its size, as such devices are typically developed and optimized by the manufacturer using internal data and then validated through these types of pre-market performance studies. The presented data represents the validation of the final product.

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

   • As no "training set" is explicitly mentioned in the context of device development or machine learning in this submission, the method for establishing its ground truth is not provided. For an IVD like this, ground truth during development would typically involve similarly prepared spiked samples with known concentrations and/or analysis by definitive reference methods like LC-MS/MS.

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The CEDIA™ Benzodiazepine Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzodiazepines in human urine at a cutoff concentration of 200 ng/mL.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used 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 results are used. For In Vitro Diagnostic Use Only.

CEDIA™ technology uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments, Enzyme acceptor (EA) and Enzyme Donor (ED). These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleaves a substrate. This generates a color change that can be measured spectrophotometrically.

The assay consists of buffers (1 and 2) and lyophilized reagents (1a and 2a). The components include sheep polyclonal anti-benzodiazepine antibody, recombinant microbial "enzyme donor'' - benzodiazepine conjugate, "enzyme acceptor", chlorophenol red ß-Dgalactopyranoside, stabilizers and preservatives. Add ß-glucuronidase enzyme to the reconstituted EA solution before using the assay. All specimens must be tested with ßglucuronidase enzyme. This enzyme will hydrolyze the glucuronidated metabolites of benzodiazepines in the samples, thereby enabling the detection of benzodiazepine glucuronides.

The provided text describes the analytical performance of the CEDIA™ Benzodiazepine Assay, an in vitro diagnostic device, and does not contain information related to an AI/ML-based device. Therefore, a direct response to the request for acceptance criteria and study details for an AI/ML device is not possible based on the provided text.

However, I can extract and present the acceptance criteria and the reported device performance for this in vitro diagnostic device based on the provided document.

Acceptance Criteria and Study for CEDIA™ Benzodiazepine Assay (In Vitro Diagnostic Device)

The CEDIA™ Benzodiazepine Assay is an in vitro diagnostic device for the qualitative and/or semi-quantitative determination of benzodiazepines in human urine. The document details its analytical performance studies to establish substantial equivalence to a predicate device, not an AI/ML-based system.

Here's a summary of the acceptance criteria (implied by the reported precision and accuracy goals) and the reported device performance from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for precision, accuracy, or other analytical performance metrics. Instead, it presents results intended to demonstrate that the device performs adequately and is substantially equivalent to a predicate device. For the purpose of this response, I will interpret the reported performance as meeting the implicit acceptance criteria for an in vitro diagnostic assay of this type.

Cut-off Concentration: 200 ng/mL

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

• Precision Study:

  • Samples were tested in replicates of 2, twice per day for 20 days.
  • Total n=80 for each spiked concentration level (0 to 400 ng/mL).
  • Data Provenance: Not explicitly stated, but the study was performed at the manufacturer's site. "Drug free urine" was used for spiking. It is implied to be laboratory-controlled samples, not patient data from a specific country or retrospective/prospective collection.

• Spike Recovery Study:

  • 20 replicates for each concentration (150 ng/mL and 250 ng/mL).
  • Data Provenance: "Drug free urine" was used for spiking. Implied laboratory-controlled samples.

• Method Comparison and Accuracy Study:

  • Sample Size: One hundred and twenty-eight (128) samples.
  • Data Provenance: Not explicitly stated. The samples were "treated with ß-glucuronidase reagent prior to analysis". This suggests potentially patient-derived urine samples, but their origin (country, retrospective/prospective collection) is not mentioned.

• Specificity (Cross-reactivity) & Interference Studies:

  • Samples made by adding known amounts of compounds to "drug-free negative urine" or "Oxazepam spiked" urine.
  • Data Provenance: Laboratory-controlled samples.

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

Not applicable for this type of in vitro diagnostic device study. The "ground truth" (or reference method) for the method comparison study was established by Liquid Chromatography/tandem mass spectrometry (LC-MS/MS), which is a highly accurate chemical analytical method. It does not involve human expert interpretation in the way AI/ML systems for medical imaging, for example, would.

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

Not applicable. Ground truth was established by LC-MS/MS, an objective chemical analytical method, not by human expert consensus 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

Not applicable. This is an in vitro diagnostic assay, not an AI/ML-based device that would assist human readers/operators in interpretation. Its performance is measured directly against a reference analytical method.

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

Yes, in the context of an IVD, the CEDIA™ Benzodiazepine Assay's performance is inherently standalone in the sense that the assay's output (positive/negative/concentration) is directly measured and compared against the LC-MS/MS reference method. There is no human interpretative step within the 'device' itself, nor is its primary purpose to augment human interpretation.

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

The ground truth for the method comparison study was Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) results, which is a gold standard chemical analytical method for drug concentration determination.

8. The sample size for the training set

Not applicable. This document describes an in vitro diagnostic assay, which is a chemical and biological reagent-based system, not an AI/ML algorithm that requires a "training set" in the computational sense. Its formulation and calibration are based on chemical principles and standard laboratory practices.

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

Not applicable, as there is no "training set" for this type of device. The assay is developed and optimized as a chemical system.

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The DRI Benzodiazepine Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL. The assay is intended to be used in laboratories a simple and rapid analytical screening procedure to detect benzodiazepines in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This assay is calibrated against Oxazepam. This product is intended to be used by trained professionals only.

The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used 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 and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

The DRI Benzodiazepine Assay is a homogeneous enzyme immunoassay with liquid ready-to-use reagents. The assay uses a specific antibody which can detect most benzodiazepines and their metabolites in urine. The assay is based on the competition of an enzyme glucose- 6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the enzyme-labeled drug is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in urine and the enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

The assay consists of reagents A and E.

Reagent A: Contains sheep polyclonal anti-benzodiazepine antibodies, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative.

Reagent E: Contains benzodiazepine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with sodium azide as a preservative.

The provided document describes the analytical performance verification of the DRI Benzodiazepine Assay, an in vitro diagnostic device, and not an AI/ML-enabled medical device. Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of device and study.

However, I can extract the acceptance criteria and reported performance for the analytical studies conducted, which demonstrate the device's substantial equivalence to a predicate device.

Device Name: DRI Benzodiazepine Assay
Regulation Number: 21 CFR 862.3170
Regulation Name: Benzodiazepine test system
Regulatory Class: Class II
Product Code: JXM

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format for each study, but rather presents the results of various analytical performance studies which are implicitly used to demonstrate the device's suitability and substantial equivalence. I will infer the acceptance criteria from typical requirements for such in vitro diagnostic assays and the presented results.

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

• Precision Studies: 80 replicates per concentration level (2 replicates, twice per day for 20 days). Samples were prepared by spiking Oxazepam into drug-free urine.
• Spike Recovery: 20 replicates for each spiked concentration (150 ng/mL and 250 ng/mL). Samples were prepared by spiking Oxazepam into drug-free urine.
• Analytical Recovery and Linearity: 10 intermediate dilution levels, each run in replicates of five. Samples were prepared by spiking Oxazepam into drug-free urine.
• Method Comparison and Accuracy: 106 patient samples.
  • Data Provenance: The document states "One hundred and six patient samples were analyzed...". The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and the company address is Fremont, CA, implying the studies were likely conducted in the US. The samples are referred to as "patient samples," which typically implies retrospective collection for assay validation, but it's not explicitly stated as retrospective or prospective.
• Specificity (Cross-reactivity & Interference): Samples were prepared by adding known amounts of compounds to drug-free negative urine, or spiking controls.

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

• Not Applicable. This is an in vitro diagnostic assay, not an AI/ML-enabled image analysis device. The ground truth for chemical analytes (benzodiazepines) in urine samples is established by a reference analytical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS), which are considered the "gold standard" for drug confirmations in toxicology. No human experts (e.g., radiologists) were involved in establishing the ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth is established by an objective chemical confirmatory method (LC-MS/MS), there is no need for human adjudication of results in the traditional sense seen in imaging studies. Discrepancies between the immunoassay and LC-MS/MS are analyzed scientifically to understand the reason (e.g., cross-reactivity with metabolites, which is precisely what the immunoassay is designed to do).

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

• Not Applicable. This is an in vitro diagnostic (IVD) assay, not an AI/ML diagnostic aid. It does not involve "human readers" in the context of image interpretation or clinical decision-making from an AI output. Its performance is evaluated analytically against a reference method.

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

• Not Applicable. This is an IVD assay. Its performance is inherently "standalone" in the sense that the device itself produces a result (qualitative or semi-quantitative) based on chemical reactions. There is no algorithm in the AI sense, nor a "human-in-the-loop" interaction directly with the assay's output similar to how one might interact with an AI-generated image finding. The results are interpreted by trained professionals.

7. The Type of Ground Truth Used

• Confirmatory Method / Gold Standard: The ground truth for benzodiazepine concentrations in urine samples was established using a "confirmatory method such as Liquid Chromatography/tandem Mass Spectrometry (LC-MS/MS)" (stated in the Indications for Use and the Method Comparison study). This is considered the preferred confirmatory method in toxicology.

8. The Sample Size for the Training Set

• Not Applicable. This is a traditional enzyme immunoassay, not a machine learning model. There is no "training set" in the context of AI/ML. The assay formulation (reagents, antibodies) is developed through biochemical research and optimization, not data-driven machine learning training.

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

• Not Applicable. (See #8). As there is no training set for an AI model, there is no ground truth to be established for it. The "ground truth" (i.e., known concentrations or presence/absence of analytes) for the samples used in analytical validation studies (e.g., linearity, accuracy, specificity) would be established using validated reference methods or precise spiking of known concentrations into a blank matrix.

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The Psychemedics Microplate EIA For Benzodiazepines in Hair is an in vitro diagnostic device for the qualitative detection of benzodiazepines in hair. The assay is intended for use in workplace settings for the qualitative analysis of human head and body hair. The assay uses a cutoff calibrator of 1 ng oxazepam/10 mg hair.

The immunoassay consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Benzodiazepines. The screening portion of the test system consists of microplate wells coated with Oxazepam conjugated to bovine serum albumin (BSA), the prepared hair sample, a cutoff calibrator added to the sample at a concentration of 1 ng Oxazepam/10 mg hair, monoclonal mouse anti-Oxazepam antibody, goat anti-mouse secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.

The confirmation assay consists of a AB Sciex API 3200 LC/MS/MS (Serial numbers AA24661109 and AA28841310) linked to two Shimazu LC-20AD Micro pumps and a Leap Technologies PAL autosampler.

The provided text describes the performance characteristics of the "Psychemedics Microplate EIA for Benzodiazepines in Hair" (the "device") and its supporting studies. The information is presented in the context of a 510(k) premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance metric in a pass/fail format. Instead, it describes validated ranges and outcomes that were considered acceptable for demonstrating the device's performance. The reported performance is directly from the tables and text provided.

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

• Test Set Sample Size:
  • Immunoassay Precision: 15 replicates per concentration for Intra-Assay (9 concentrations), 75 replicates per concentration for Inter-Assay (9 concentrations over 5 days).
  • LC-MS/MS Precision: For each of the six benzodiazepines, between 4 and 5 authentic samples were tested in triplicate.
  • LC-MS/MS Linearity: 8 concentrations plus a zero concentration sample were evaluated. The number of replicates per concentration is stated as five (implied for linearity validation criteria).
  • LC-MS/MS LLOQ: Not explicitly stated how many samples were used, but acceptance criteria were met.
  • Immunoassay Specificity (Cross-reactivity): Various concentrations of 27 benzodiazepines. Not specified how many unique samples/tests per compound.
  • Immunoassay Specificity (Interference): At least 70 unique compounds, each tested at 100 ng/10 mg hair on samples spiked with oxazepam at cutoff and ±50% of cutoff. Not specified how many replicates per compound.
  • LC-MS/MS Specificity (Cross-reactivity): 9 structurally related compounds. Not specified how many unique samples/tests per compound.
  • LC-MS/MS Specificity (Interference): 30+ structurally unrelated compounds. Not specified how many unique samples/tests per compound.
  • Accuracy (Method Comparison): 382 hair samples (318 head hair, 64 body hair).
• Data Provenance: The general context implies that the data was collected at the manufacturer's site ("Psychemedics plans to perform this test at one site"). The type of data appears to be prospective as it involves experimental testing of the device's performance characteristics. The document does not specify the country of origin of the data beyond the manufacturer's location in Culver City, CA, USA, and the FDA's US location.
  • For the accuracy study, the samples represented diverse hair colors (159 black, 197 brown, 8 blond, 4 red, 14 gray) and ethnicities (175 Caucasian, 40 African-American, 125 Hispanic, 41 Asian subjects). This suggests real-world samples were used.

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 human experts or readers to establish ground truth for the analytical studies. The ground truth for the test set is established through confirmatory chemical methods, specifically Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS), which is the gold standard for quantitative drug analysis in forensic and clinical toxicology. These methods are analytical and do not typically involve human expert interpretation for "ground truth" in the same way imaging studies might.

4. Adjudication Method for the Test Set

Not applicable. The ground truth is established by a definitive chemical analysis (LC/MS/MS), not through human review or adjudication of qualitative results.

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

Not applicable. This device is an in vitro diagnostic (IVD) test, specifically an immunoassay for drug detection. It is not an AI-powered image analysis tool that assists human readers/interpreters. Therefore, MRMC studies and human reader improvement are not relevant to this type of device.

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

Yes, the studies presented are essentially "standalone" performance evaluations of the device technology (immunoassay and LC/MS/MS). The immunoassay provides a preliminary screening result, and the LC/MS/MS provides a confirmed analytical result. Human involvement is in operating the instruments and interpreting the quantitative data, rather than forming a diagnostic opinion that is then augmented or compared to an AI algorithm.

7. The Type of Ground Truth Used

The primary ground truth used for evaluating the device's performance is chemical confirmation via Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS). This is considered the "confirmatory method" and is explicitly described as "a more specific alternate chemical method must be used to obtain a confirmed analytical result." This is a highly objective and quantitative method for identifying and measuring specific benzodiazepines. The document also points out that the immunoassay results (qualitative) were interpreted relative to the LC/MS/MS quantitative results, taking into account cross-reactivity for clarity in discordant cases.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is an immunoassay, which is a biochemical assay, not an AI algorithm that requires training data in the traditional sense. The studies described demonstrate the analytical performance of the immunoassay and the confirmatory LC/MS/MS method.

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

As there is no mention of a "training set" for an AI algorithm, this question is not applicable to the presented information. The ground truth for the validation/test samples (as discussed in point 7) was established through LC/MS/MS.

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Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:

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

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.

A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Propoxyphene, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each drug for the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card in the lay user study can be inferred as achieving at least 85% agreement with GC/MS results for urine samples near the cutoff concentrations (+/- 25% of cutoff). For samples further away from the cutoff (±50%, ±75%, -100% of cutoff), the acceptance criterion appears to be 100% agreement.

Healgen Multi-Drug Urine Test Cup and Dip Card Performance (Lay User Study Data)

The device meets these acceptance criteria, as all reported percentage agreements are at or above the specified thresholds for each drug and concentration level.

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

• Sample Size for Test Set:
  • For each drug analyte tested in the lay user study, the total number of samples evaluated was 300 per format (Cup and Dip Card) across different concentration levels.
  • Specifically, for each drug analyte, the breakdown of samples by concentration was:
    • -100% Cutoff: 20 samples
    • -75% Cutoff: 20 samples
    • -50% Cutoff: 160 samples
    • -25% Cutoff: 20 samples
    • +25% Cutoff: 20 samples
    • +50% Cutoff: 40 samples
    • +75% Cutoff: 20 samples
• Data Provenance: The document does not explicitly state the country of origin of the data. However, as it is a submission to the United States FDA, it is implied that the data is intended for use in the US market. The study utilized "drug free-pooled urine specimens" which were then spiked with drugs, indicating a controlled laboratory setting for sample preparation. The study was conducted at "three intended user sites" with "lay persons," suggesting a prospective evaluation of the device by untrained users.

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

• Number of Experts: Not applicable in the context of this study. The ground truth was not established by human experts interpreting results from the device itself.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an objective chemical analysis method, not a subjective interpretation requiring adjudication among experts. The lay users independently read the results from the test devices.

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement of the device's results (read by lay users) with a gold standard (GC/MS), rather than comparing the performance of human readers with and without AI assistance. The device itself is a lateral flow immunoassay, not an AI system.

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

• Yes, a standalone study was done in the sense that the device's performance was compared directly against a definitive analytical method (GC/MS). The lay user study involved individuals interpreting the results of the device directly, without the intervention of an algorithm or AI to assist in that interpretation. The comparison is between the human interpretation of the device and the chemical gold standard, effectively evaluating the standalone performance of the rapid immunoassay device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The concentrations of the samples were confirmed by GC/MS." GC/MS is a highly accurate and widely accepted method for confirming the presence and concentration of drugs in urine, thus serving as the gold standard.

8. The Sample Size for the Training Set

• The document does not explicitly mention a training set in the context of the lay user study or the development of this specific final product (Healgen Multi-Drug Urine Test Cup/Dip Card). The performance data cited (precision, cut-off, interference, specificity, and method comparison) refers to earlier, individual FDA-cleared predicate devices (K142280, K143187, etc.). It's possible that earlier development and validation work for those predicate devices constituted a "training" or development phase, but details are not provided here. This document primarily describes the validation of the multi-drug format for lay use against a gold standard.

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

• As a training set is not explicitly described for this submission, the method for establishing its ground truth is not provided. However, for similar in-vitro diagnostic devices, the ground truth for training/development (if applicable) would typically be established using validated laboratory reference methods such as GC/MS or LC/MS, similar to the method used for the test set.

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The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine. EDDP. Nortriptyline and Methadone in human urine at the cutoff concentrations of:

Configurations of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes up to a maximum of 14 analytes. Only one cutoff concentration will be included per analyte per device.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized drug levels for Buprenorphine. Nortriptyline or Oxycodone in urine. 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.

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips.

A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are devices for qualitative and simultaneous detection of various drugs in human urine. The study conducted was a lay user study to verify the device's performance when used by individuals without professional training.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the percentage agreement with GC/MS (Gas Chromatography/Mass Spectrometry) results for different drug concentrations relative to the cutoff level. While no explicit percentage agreement threshold is stated as an "acceptance criteria", standard practice in such studies would expect high agreement for samples at or significantly away from the cutoff. The reported performance shows high agreement, particularly at concentrations of -50% Cutoff, +50% Cutoff, and +75% Cutoff.

Reported Device Performance based on Lay User Study (Agreement with GC/MS):

Note: The specific percentage agreement for -25% and +25% cutoff concentrations varied slightly across different drugs and device types (dip card vs. cup). For instance, Morphine at +25% Cutoff for the dip card and Oxycodone at +25% Cutoff for the cup showed 85% agreement, while others were 90-95%. Oxazepam at -25% Cutoff for the cup also showed 85% agreement.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: For each drug and concentration level (e.g., Methamphetamine at -100% Cutoff), there were between 20 and 170 samples tested. Each device format (Cup and Dip Card) was tested with these samples across all drugs.
  • For -100%, -75%, -25%, +25%, +75% Cutoff, there were 20 samples each.
  • For -50% Cutoff, there were 170 samples.
  • For +50% Cutoff, there were 50 samples.
  • Total samples per drug per device format were 20+20+170+20+20+50+20 = 320 samples.
  • Given there are 14 drugs, the total number of samples processed by lay users for each device format would be approximately 14 drugs * 320 samples/drug = 4480 samples.
• Data Provenance: Not explicitly stated regarding the country of origin of the data. The study was a prospective lay user study where urine samples were prepared and then tested by lay users.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the context of human readers for generating ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was established by an independent laboratory method (GC/MS, see point 7).

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

• MRMC Study: No, this was not a MRMC comparative effectiveness study involving human readers with and without AI assistance. This study focused on the performance of a point-of-care test when interpreted by lay users.

6. Standalone Performance

• Standalone Performance: Yes, the study evaluates the standalone performance of the device (Healgen Multi-Drug Urine Test Cup and Dip Card) when used directly by lay users. The outcome of the device (positive/negative line on the test strip) as interpreted by the lay user is compared against the GC/MS reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the test set was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is the preferred confirmatory method for drug concentration in urine samples.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a separate training set. The device is a lateral flow immunochromatographic assay, not an AI/ML algorithm that typically requires a training set. The "performance data of precision, cut-off, interference, specificity and method comparison" were reported in predicate device submissions (K142280, K143187, K141647, K140546, K150791, K150096 and K151348), implying these established characteristics during the development of earlier versions.

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

• Ground Truth for Training Set: Not applicable as there is no specific "training set" for the device in the context of AI/ML or expert interpretation. The performance characteristics of the assay would have been established through a series of analytical studies using known concentrations and confirmed methods (like GC/MS) during its development and prior submissions, which serve as the foundation for the assay's expected behavior.

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The Immunalysis Benzodiazepines Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Benzodiazepines in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxazepam. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.

The Immunalysis Benzodiazepines 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. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and Oxazepam. The calibrators are designed for prescription use with immunoassays.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Benzodiazepine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Benzodiazepines derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative.

All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. 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 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles.

Here's an analysis of the acceptance criteria and the studies performed for the Immunalysis Benzodiazepines Urine Enzyme Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for all aspects of the testing. However, we can infer the performance expectations from the study descriptions and reported results. The core acceptance for qualitative and semi-quantitative results (positive/negative determination around the cutoff) is that the device should accurately classify samples at various concentrations relative to the 200 ng/mL cutoff, and not be significantly affected by common interferents or physiological variations. For cross-reactivity, it's expected that related compounds will show a response, ideally correlating with their known activity, and unrelated compounds should not cause false positives.

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

• Precision/Cutoff Characterization (Tables 3 & 4): 80 determinations for each concentration level (0, 50, 100, 150, 200, 250, 300, 350, 400 ng/mL). Given 20 days, 2 runs per day in duplicate, this means 20 days * 2 runs * 2 duplicates = 80 determinations. These were spiked drug-free urine samples.
• Specificity and Cross-Reactivity (Tables 5 & 6): For each of the approximately 30 structurally related compounds, a "Result" (POS/NEG) is reported at a specific "Concentration Tested." The exact number of determinations per compound is not explicitly stated but is typically multiple replicates. The samples were drug-free urine spiked with the respective compounds.
• Interference (Structurally Unrelated Compounds - Table 7): For each of the approximately 109 compounds, tests were performed at two concentrations (-25% and +25% of cutoff). The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at ±25% of the cutoff, spiked with the interferent.
• Interference (Endogenous Compounds - Table 8): For each of the approximately 15 compounds, tests were performed at two concentrations (-25% and +25% of cutoff). The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at ±25% of the cutoff, spiked with the interferent.
• Interference (Boric Acid - Tables 9 & 10): Tests were performed at ±25% and ±50% of the cutoff with 1% w/v Boric Acid. The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at these levels.
• Interference (pH - Table 11): Tests were performed at 9 different pH values (3.0-11.0) at ±25% of the cutoff. The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at these levels.
• Interference (Specific Gravity - Table 12): Tests were performed at 8 different specific gravity values (1.000-1.030) at ±25% of the cutoff. The exact number of determinations is not specified. Samples were drug-free urine containing oxazepam at these levels.
• Linearity/Recovery (Table 13): 11 different concentrations were tested, each "in triplicate."
• Method Comparison (Tables 14-16): 80 "unaltered, anonymous and discarded clinical urine samples."
  • Data Provenance: The Method Comparison study used "unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This implies retrospective data from (presumably) US clinical labs. All other studies (Precision, Specificity, Interference, Linearity) used artificially prepared samples (drug-free urine spiked with controlled concentrations of analytes/interferents).

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

This type of in-vitro diagnostic device (IVD) study does not typically involve human experts to establish ground truth in the way medical imaging or pathology studies do. The ground truth for drug presence and concentration in urine samples is established using analytical gold standards like Mass Spectrometry (MS), specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). These are laboratory techniques, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable in the human expert sense. For analytical discrepancies between the device and the reference method (LC/MS in the Method Comparison study), standard laboratory protocols for investigating outliers or re-testing would be followed, but there isn't an "adjudication" by a panel of human experts.

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 an automated in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers. Its primary output is a quantitative or qualitative chemical result, not an image or diagnosis requiring human interpretation with or without AI assistance.

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

Yes, the studies presented are all standalone performance studies of the device (an immunoassay performed on an automated clinical chemistry analyzer). Its performance is evaluated directly against spiked samples or a reference method (LC/MS) without human interpretative input influencing the device's result. The output itself (positive/negative, semi-quantitative values) then requires professional judgment for clinical application, as stated in the Indications for Use, but the device's analytical performance itself is standalone.

7. The Type of Ground Truth Used

• Mass Spectrometry (MS): For the Precision/Cutoff Characterization, "The spiked concentrations were confirmed by mass spectrometry (MS)." For the Method Comparison study, "Results were obtained... with LC/MS." This is the primary gold standard for determining the true presence and concentration of drugs/metabolites in urine.
• Spiked Concentrations: For precision, specificity, interference, and linearity studies, known concentrations of pure compounds spiked into drug-free urine served as the ground truth.

8. The Sample Size for the Training Set

The document describes an in-vitro diagnostic assay based on immunoassay technology. Immunoassays are fundamentally different from machine learning algorithms that require "training sets." They are analytical chemical reactions with pre-defined reagents and methodologies. Therefore, the concept of a "training set" in the context of machine learning does not apply here. The device's "training" or optimization would involve chemical formulation, antibody selection, and parameter tuning during its development phase, but not a data-driven training set in the AI sense.

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

As explained in point 8, the concept of a "training set" as it relates to AI is not applicable to this immunoassay device. The "ground truth" for the development and optimization of such assays relies on analytical chemistry principles, precise formulation of reagents, and verification with reference methods using samples with known, carefully prepared concentrations of analytes.

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Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine at the cutoff concentrations of.

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

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam. Secobarbital and Oxyodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

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

The provided document is a 510(k) premarket notification for the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain a detailed study report with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or adjudication methods for performance evaluation.

The document states: "Verification studies were conducted in support of the modification to have a multi-drug test cup and test card test, including interference studies and a lay-user study. Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates." This indicates that studies were performed, but their details are not included in this FDA letter.

Therefore, I cannot provide the requested information from the given text alone. The document mentions that the new devices are considered substantially equivalent to existing predicate devices based on "acceptable performance characteristics", but does not elaborate on what those characteristics or the detailed performance results are.

To answer your request, a full study report from Healgen Scientific LLC detailing the performance characteristics and the supporting data would be necessary.

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Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of:

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

The test may yield positive results for the prescription drugs oxazepan and oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific altemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone, in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The provided document describes the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone in human urine.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding performance metrics like sensitivity, specificity, or accuracy for the device as a whole. Instead, it provides the cut-off levels for each drug, which serve as a critical component of the device's performance specification.

The performance characteristics are implied by the statement: "Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates." This suggests that the device's performance was deemed adequate during verification studies. However, specific values for sensitivity, specificity, etc., for the new multi-drug device are not presented.

A table of the specified cut-off levels is provided in the document:

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

The document mentions "verification studies" and "interference studies and a lay-user study" were conducted. However, the exact sample size for the test set is not explicitly provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a diagnostic test, not an AI-assisted diagnostic tool, so this type of study is not relevant in this context.

6. Standalone (Algorithm Only) Performance Study

As this is a lateral flow immunoassay device, it does not involve algorithms in the sense of AI or software. Therefore, a standalone (algorithm only) performance study is not applicable and not reported. The device's performance is driven by its biological and chemical components.

7. Type of Ground Truth Used

The document states that a "more specific analytical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method." This indicates that chromatography-mass spectrometry (GC/MS or LC/MS) is the intended gold standard/ground truth for confirming the preliminary results of the device. It is highly probable that similar analytical methods were used to establish the ground truth in the verification studies, although not explicitly stated for the studies performed.

8. Sample Size for the Training Set

The document does not mention or specify a training set sample size. As a lateral flow immunoassay device, it does not typically involve machine learning with separate training and testing datasets in the way an AI diagnostic algorithm would. Its development relies on biochemical optimization and validation.

9. How Ground Truth for the Training Set Was Established

Since there is no "training set" in the context of machine learning, the method for establishing its ground truth is not applicable and not described. Ground truth for assay development would typically involve precisely prepared samples with known drug concentrations, confirmed by highly accurate analytical methods like GC/MS or LC/MS.

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