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The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

The Detectabuse® controls are designed to provide an estimation of the precision of a device test system, and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects, at levels established by SAMHSA, CAP/AACC, many state programs and device manufacturers QC requirements. The Detectabuse® control urines are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents. They should be treated as any "unknown" specimen while following the specific protocol of the assay being used. This product is intended to be used under the supervision of health care professionals as an integral part of good laboratory practices.

Each bottle contains stabilized human based urine. Multi-constituent and single constituent positive control urines have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain less than 1% sodium azide as a preservative. For assays sensitive to sodium azide such as ELISA we substitute a proprietary preservative approved by the manufacturers and DEA.

This document describes the performance characteristics and acceptance criteria for the Detectabuse® Liquid Control Urine device. This device is an In Vitro Diagnostic (IVD) intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures.

The study that proves the device meets the acceptance criteria is primarily an analytical performance study focusing on stability and traceability.

1. Table of Acceptance Criteria and Reported Device Performance

| Evaluation Parameter | Acceptance Criteria | Reported Device Performance |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| Open Bottle Stability at 2-8°C | 31 days | Data support the 31-day open bottle stability at 2-8°C for all analytes. All analytes passed specifications, Positive controls tested positive, and Negative controls tested negative. |
| Closed Bottle Stability - Product Shelf Life (2-8°C) | Storage with Oxazepam expected to be negatively affected if >6 months. Other drugs within ±15% of target until expiration. | At 1 year, Oxazepam dropped 15-22%. At 3 years, Oxazepam dropped to 25%. Other drugs were within acceptable criteria of +/-15% from target until expiration date. Recommendation: Do not store Oxazepam-containing controls refrigerated for more than six months. |
| Closed Bottle Stability - Product Shelf Life (-10°C to -20°C) | Up to 4 years. Values within ±15% of target or original test value. | Multiple studies with various lots showed all drugs were stable within 15% of target or original test value between 3 and 4 years of frozen storage. |
| Room Temperature (open vial) Stability - Product Shelf Life (18°C to 21°C) | 31 days. Values within ±18% of target or original test value. | All drugs tested for 31 days were within 18% of target value or original test value. This supports stability during shipping or brief periods of customer error. |
| Value Assignment Criteria | Initially: ±5% agreement (acceptable to ±10% for certain difficult-to-test drugs). For Stat-Skreen® controls, positive controls must test positive and negative controls test negative. Final testing at shelf life: ±10% of target (acceptable to ±15% for certain stability-prone constituents like Oxazepam). | Initial production batch samples sent to 4-5 certified laboratories (at least 3 proficient for specific constituents). If a testing laboratory does not report within 10% of target, the sample is repeated. Once acceptable convergence of values is achieved, the lot is released. Stat-Skreen® controls are also tested on handheld devices against the criteria. Final testing at shelf life (GC/MS or LC/MS) aims for ±10% of target but accepts up to ±15% for specific constituents like Oxazepam. |

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

The document does not explicitly state a numerical sample size for "test sets" in the context of typical algorithm validation (i.e., a distinct set used for performance evaluation after training). Instead, the performance evaluations are described for stability studies and value assignment verification.

• Stability Studies: "Multiple bottles of a single lot" were pulled from beginning, middle, and end of production. "Several lots" of controls were selected for the room temperature study. "Multiple studies were conducted using various different lots."
• Value Assignment: "An initial production batch is sampled as described in the protocol and single or multiple samples (depending on our past experience with the constituent(s), are ordinarily sent out to 4 or 5 certified laboratories..."
• Data Provenance: The data is generated through laboratory testing of the control materials. The document implies a prospective data collection for stability studies (testing at initial, then at intervals) and for value assignment. The "certified independent laboratories" or "SAMHSA licensed laboratories or CAP inspected and certified" are likely located in the USA, given the FDA submission context.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment for Value Assignment: "Certified Independent laboratories" test by either GC/MS, LC/MS, or Immunoassay screening. For initial value assignment, "4 or 5 certified laboratories" (or at least 3 for less common constituents) perform testing. The qualifications for personnel performing these tests at "certified" or "SAMHSA licensed" or "CAP inspected and certified" labs are implied to be high, but specific expert qualifications (e.g., "radiologist with 10 years of experience") are not detailed. The expertise is in the analytical methods (GC/MS, LC/MS, immunoassay).

4. Adjudication Method

The adjudication method for value assignment resembles a form of consensus or agreement-based approach.

• "A minimum of 3 data points are collected for each assay."
• "Data collected from at least two test sites, testing performed within 1 week of receipt of test samples."
• "Our target acceptance criteria Is ±5% of the target value, but if we cannot get ± 5% agreement from our testing laboratories we will accept ± 10%... If a testing laboratory does not report within 10% of target we ask that the sample be repeated. Once we have an acceptable convergence of values from all of the testing laboratories the lot is released."

This suggests repeated testing and comparison among multiple labs with defined acceptance thresholds for agreement, rather than a formal 2+1 or 3+1 adjudication by individual experts in the traditional sense for image interpretation.

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

• No MRMC comparative effectiveness study was done. This device is a quality control material, not an AI diagnostic tool intended to assist human readers. Therefore, the concept of improving human reader performance with AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

• A standalone performance study was done in the sense that the device, as a quality control material, is evaluated on its own analytical properties (stability, assigned values, precision monitoring capability) using laboratory instruments. There isn't an "algorithm" in the typical AI sense; the "device" itself is the control material. Its performance is measured by how precisely and accurately analytical instruments can detect the specified concentrations within the control.

7. Type of Ground Truth Used

The ground truth used for this device is based on analytical quantification methods and certified reference standards:

• Gravimetric spiking with authentic reference drug standards and/or appropriate metabolites.
• Purity determination using analytical tools including GC/MS, LC/MS, and NMR.
• Balances calibrated with weights traceable to National Institute of Standards and Technology (NIST).
• Testing by SAMHSA or CAP certified independent laboratories using GC/MS, LC/MS, or Immunoassay screening.
• Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS.

This constitutes a highly rigorous, metrologically traceable analytical ground truth.

8. Sample Size for the Training Set

The concept of a "training set" as understood in machine learning is not applicable here. This device is a chemical control material, not an AI algorithm that learns from data. The manufacturing and validation processes involve:

• Reference standards and gravimetric preparation: These form the basis for the intended concentrations.
• Initial production batches: These are the manufacturing lots that undergo value assignment and stability testing as described above.

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

As noted above, there is no "training set" in the AI sense. The "ground truth" (i.e., the known and verified concentrations of analytes in the control material) is established through:

• Precise gravimetric preparation: Spiking authentic reference drug standards (traceable to NIST) into the human-based urine matrix at known concentrations.
• Purity verification of reference standards: Using advanced analytical techniques such as GC/MS, LC/MS, and NMR.
• Verification by multiple independent certified laboratories: The value assignment process, involving multiple labs and stringent acceptance criteria, serves to confirm the prepared concentrations with high confidence.

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The Salivabuse® liquid oral fluid controls are intended for in vitro diagnostic use only as quality controls to monitor the precision of laboratory oral fluid toxicology testing procedures for the analytes listed in the package insert. The Salivabuse ® controls are available as multi-constituent and single constituent controls.

The Salivabuse ® multi-constituent and the Salivabuse® single constituent controls are designed to provide an estimation of the precision of a device test system, and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. Salivabuse® liquid oral fluid controls are available in Negative, Cutoff -60%, Cutoff -50%, Cutoff -30%, Cutoff -25%, Cutoff, Cutoff +2.5%. Cutoff +50%. 2X Cutoff and 3X Cutoff levels. Each bottle contains stabilized synthetic oral fluid. Positive controls have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative controls are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain either sodium azide or a proprietary preservative compatible with products that are adversely affected by sodium azide.

Here's an analysis of the acceptance criteria and the study conducted for the Salivabuse® Liquid Oral Fluid Control, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text describes stability testing and value assignment for the Salivabuse® controls.

• Stability Studies (Test Set):

  • For each temperature condition (Refrigerated Open, Refrigerated Closed, Frozen Closed), 3 lots were tested.
  • From each lot, 3 vials were tested.
  • This means a minimum of 9 vials were used per temperature condition (3 lots * 3 vials).
  • Data Provenance: The studies are described as "real time and accelerated stability testing" and "ongoing," suggesting a prospective nature. The manufacturer, Biochemical Diagnostics, Inc., is based in Edgewood, NY, USA, which implies the data provenance is likely from the USA, although specific geographic locations for testing labs are not explicitly stated beyond "Certified Independent laboratories."

• Value Assignment (Test Set):

  • An "initial production batch is sampled from the beginning, middle and end of production."
  • "Single or multiple samples were analyzed." The exact number of samples is not specified.
  • Data Provenance: Similar to stability, likely USA, from "Certified Independent laboratories using...SAMHSA licensed laboratories or CAP inspected and certified laboratories."

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

The concept of "experts" in the traditional sense (e.g., radiologists) is not applicable here. This device (Salivabuse®) is a quality control material, not a diagnostic imaging or interpretive device.

• Ground truth for quality control materials is established through analytical methods and certified reference standards.

• For value assignment and stability testing, the "ground truth" and verification of performance were established through:

  • Certified Independent laboratories
  • SAMHSA licensed laboratories or CAP inspected and certified laboratories
  • These laboratories use established analytical techniques:
    • GC/MS (Gas Chromatography/Mass Spectrometry)
    • LC/MS (Liquid Chromatography/Mass Spectrometry)
    • Immunoassay analyzers
    • FDA cleared drugs of abuse screening devices

  The qualifications of the personnel performing these analyses at these certified laboratories would align with standard laboratory practices for toxicology and clinical chemistry, but specific titles (e.g., "toxicologist with 10 years of experience") are not provided. The certification of the laboratories (SAMHSA, CAP) inherently implies qualified personnel and accredited procedures.

4. Adjudication Method for the Test Set

Adjudication, in the sense of resolving discrepancies between multiple human reviewers, is not applicable here. The "adjudication" for this type of device is inherent in the analytical methods and the acceptance criteria:

• For Immunoassay and single-use devices, the outcome is binary: positive or negative.
• For GC/MS and LC/MS, the outcome is quantitative, with acceptance criteria defined as being within a certain percentage of the target value.
• The multiple lots and vials tested provide a form of internal validation, where consistent results across these samples confirm the stability and accuracy.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where accuracy depends on human interpretation (e.g., image-reading AI). The Salivabuse® control is an in vitro diagnostic quality control material, not a diagnostic device requiring human interpretation in its intended use.

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

This question is also not applicable in the context of this device. The Salivabuse® control is itself a "standalone" product (a liquid control material). Its performance is evaluated through its physical and chemical stability and its ability to elicit expected analytical results when run on various testing platforms (immunoassay, GC/MS, LC/MS). There is no "algorithm" to evaluate in isolation from human input.

7. The Type of Ground Truth Used

The ground truth for the Salivabuse® control material is established through:

• Analytical Chemistry and Reference Standards:
  • Gravimetric spiking with authentic reference drug standards and/or appropriate metabolites.
  • Purity determination using analytical tools including GC/MS or NMR.
  • Balances calibrated with weights traceable to National Institute of Standards and Technology (NIST).
  • Certified negative by combination of immunoassay, GC/MS and/or LC/MS for negative controls.
  • Confirmed by quantitative GC/MS and/or LC/MS performed by SAMHSA licensed or CAP inspected/certified laboratories.

This is a form of analytical ground truth derived from precise chemical preparation and validated analytical methods.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this device. Salivabuse® is a quality control material whose properties are precisely manufactured and then verified. It is not an AI/ML algorithm that requires training data.

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

As there is no training set for this device, this question is not applicable.

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The Multichem WBT control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.

Technopath has developed whole blood control materials prepared from human whole blood, to which whole blood purified biochemical material (extracts of human origin), chemicals, drugs, preservatives and stabilizers have been added. Three levels of control are available to allow performance monitoring within the analytical range.

The provided document is a 510(k) summary for the Multichem WBT control, a quality control material used to monitor the precision of laboratory testing procedures for specific analytes (Cyclosporine, Sirolimus, Tacrolimus).

It describes the device, its intended use, comparison to a predicate device, and performance characteristics focused on traceability, value assignment, and stability. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a ground truth through a clinical study involving human readers or standalone algorithm performance.

The "performance characteristics" detailed in the document refer to:

• Traceability Summary: States the analytes are from commercial sources or endogenous to the base matrix, and no claim of traceability to higher order reference materials is made. This is not a measure of accuracy against a clinical ground truth.
• Value Assignment Summary: Describes how typical values for the control material were determined using an Abbott ARCHITECT i2000 chemistry system. It involved 2 reagent lots, 2 calibrator lots, 16 runs (32 data points), and 8 calibration events. The "predetermined criteria of 30% around the grand mean" was used to establish value assignment ranges, and all values fell within these ranges. This is about establishing the expected range for the control itself, not about its diagnostic accuracy or impact on human performance.
• Stability Testing Summary: Details open-vial and shelf-life stability studies. Open-vial stability was assessed using CLSI EP25A, with a maximum allowable drift (degradation) of 10% to determine the point of failure. Shelf-life was supported by accelerated and preliminary real-time testing using CLSI EP25A, also with a 10% drift limit, predicting stability for 30 months. This relates to the product's physical and chemical integrity over time, not its performance in a diagnostic context.

Since the device is a quality control material, the typical metrics for a diagnostic device (like sensitivity, specificity, reader performance) are not applicable in this context. The "performance" here refers to the consistency and stability of the control material itself.

Therefore, the requested information elements cannot be fully addressed in the format of a typical diagnostic device study due to the nature of the device (a quality control material).

However, I can extract the relevant information where it exists:

1. A table of acceptance criteria and the 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)

• Value Assignment:
  • Test Set Sample Size: 32 data points (replicates from 16 runs)
  • Data Provenance: Not explicitly stated, but performed internally by Technopath. Implied prospective as it was done to determine typical values for the product.
• Stability Testing:
  • Test Set Sample Size: "Multiple time points" tested for open-vial stability; three lots of controls for accelerated testing; three lots of controls for preliminary real-time testing.
  • Data Provenance: Not explicitly stated, but performed internally by Technopath. Prospective studies.

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)

• Not applicable (N/A): This device is a quality control material, not a diagnostic device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for this device relates to its chemical properties and performance on a specific analytical instrument.

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

• N/A: As above, this is not a diagnostic device requiring adjudication of expert interpretations.

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

• N/A: This is not a diagnostic device, and thus no MRMC study, human reader improvement, or AI assistance is relevant.

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

• N/A: This is a physical quality control material, not an algorithm. Its performance is measured through its interaction with an analytical instrument (Abbott ARCHITECT i2000).

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

• Value Assignment: The "truth" is an internally determined grand mean, against which individual measurements were compared to establish ranges. This is a form of internal reference standard based on instrument performance.
• Stability Testing: The "truth" is the initial established value of the control material, and subsequent measurements over time are compared against this initial value to determine drift/degradation.

8. The sample size for the training set

• N/A: This device is a quality control material and does not involve AI model training. The performance studies described are for quality control and stability, not for training a predictive model.

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

• N/A: As there is no training set for an AI model, this is not applicable.

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The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

Not Found

This is a 510(k) premarket notification for a medical device called "Detectabuse® Liquid Control." This document focuses on the regulatory approval of this device, rather than a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, the requested information regarding specific acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study is not present in the provided document.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device meeting the same "indications for use" as existing devices, rather than providing specific performance metrics against pre-defined acceptance criteria in a clinical study context.

In the context of this 510(k) summary, the "acceptance criteria" are broad regulatory requirements for substantial equivalence, and the "study" referred to would be the comparison to predicate devices, which is not detailed in terms of performance metrics.

In summary, the provided document does not contain the specific performance data and study details requested in your prompt.

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Liquichek Whole Blood Immunosuppressant Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

This product is prepared from human whole blood with added preservatives and stabilizers. The control is provided in liquid form for convenience.

Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert. Each laboratory should establish its own means and acceptable ranges based on their own test system and tolerance limits.

Here's a breakdown of the acceptance criteria and study information for the Liquichek Whole Blood Immunosuppressant Control, based on the provided document:

This document is a 510(k) submission for a quality control material, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, the "acceptance criteria" here relate to the stability and similar performance to a predicate device, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the stability studies or other performance tests. It refers to "replicate analyses," implying multiple measurements were taken for the stability studies.

The data provenance is internal to Bio-Rad Laboratories, as stated in Section 8.0: "All supporting data is retained on file at Bio-Rad Laboratories." No country of origin is specified for the data itself, but the manufacturer is based in Irvine, California, USA. The studies appear to be prospective in nature, as they are establishing new stability claims for a new device.

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

This type of information is generally not applicable to the evaluation of a quality control material. The "ground truth" for a quality control material is its known concentration of analytes, established through highly controlled laboratory methods. Experts in the traditional sense (e.g., radiologists interpreting images) are not involved in setting the "ground truth" for chemical controls.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used for studies involving subjective human interpretation, such as image reading. This is not relevant for the evaluation of a quality control material, where stability and analytical performance are measured objectively.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., medical imaging AI). The Liquichek Whole Blood Immunosuppressant Control is a quality control material for laboratory instruments.

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

This concept is also not applicable. This device is a control material, not an algorithm or a diagnostic test that produces results that require human interpretation or algorithmic processing. Its performance is evaluated by its chemical stability and its ability to deliver consistent results when run on an assay.

7. The Type of Ground Truth Used

The ground truth for this quality control material is its known concentration of analytes. This is established through the manufacturing process and confirmed by analytical testing using reference methods. For example, "Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert." This indicates that the expected values for the control are determined by the manufacturer through precise analytical measurements.

8. The Sample Size for the Training Set

This concept is not applicable. This product is a physical quality control material, not a machine learning algorithm. Therefore, there is no "training set."

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

As there is no "training set" for this type of device, this question is not applicable.

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Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology screening procedures.

Liguichek Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.

The provided text is for a 510(k) premarket notification for a medical device (Liquichek Urine Toxicology Control). A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove performance against specific acceptance criteria.

Therefore, many of the requested elements (e.g., sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or not present in this type of regulatory document. This document is a Summary of Safety and Effectiveness, which details the device, its intended use, and how it compares to a legally marketed predicate device. The "Statement of Supporting Data" section primarily addresses stability studies for the control material itself, not the performance of an AI-driven diagnostic device.

Here's an analysis based on the available information:

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

The document does not specify "acceptance criteria" in the sense of performance thresholds for an AI or diagnostic algorithm (e.g., sensitivity, specificity). Instead, it describes claims related to the stability of the control material. The "reported device performance" in this context refers to the validated stability periods.

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

• Not applicable / Not provided. This document does not describe a "test set" for evaluating a diagnostic algorithm. The studies mentioned are stability studies for a quality control material.

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)

• Not applicable / Not provided. This is a quality control material, not a diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable / Not provided.

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 study was not done. This device is a quality control material, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This device is a quality control material, not a standalone diagnostic algorithm.

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

• For the stability studies, the "ground truth" would be established by analytical testing using validated methods (e.g., mass spectrometry, immunoassays) to confirm the concentration and integrity of the analytes within the control material over time and under different storage conditions. The document doesn't detail the specific analytical methods, but these are standard lab practices for control materials.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/ML device.

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

• Not applicable / Not provided.

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MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH.

MAS® DOA Total provides an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.

DOA TOTAL is prepared from certified drug free human urine pools. Analyte levels are adjusted with purified drugs or drug metabolites. Preservatives and stabilizers are added to maintain product integrity.

DOA TOTAL offers levels of controls, at concentrations 25% below and 25% above the screening cutoff levels used by the United States Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA); for Amphetamines, PCP (Phencyclidine), Opiates, Cocaine and Marijuana (Cannabinoid).

Here's a breakdown of the acceptance criteria and study information for the Thermo Scientific MAS® DOA Total device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes control materials (MAS® DOA Total) intended for monitoring assay conditions, not a diagnostic device that processes patient samples to generate a result. Therefore, the concept of a "test set" with patient samples and data provenance (e.g., country of origin, retrospective/prospective) as typically applied to diagnostic algorithms is not directly applicable here.

Instead, the "test set" here refers to the batches of the control material itself that were subjected to various stability and target achievement evaluations. The sample size for these evaluations is not explicitly stated in the provided summary. However, the evaluation parameters imply testing across different levels (L1-L6) and over time for stability studies.

The data provenance is internal to Thermo Fisher Scientific, as they manufactured and tested these control materials.

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

This question is not applicable to this device. MAS® DOA Total is a control material with defined analyte concentrations. The "ground truth" for the control material's composition is established by the manufacturing process and analytical chemistry techniques used to prepare and characterize the material, not by expert interpretation.

4. Adjudication Method for the Test Set

This question is not applicable to this device. As the device is a control material with defined chemical compositions, there is no need for expert adjudication of results. The "truth" is inherent in the manufacturing specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and an AI-powered system might assist or replace them. MAS® DOA Total is a control material, not a diagnostic algorithm or a system that involves human interpretation of patient cases.

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

This question is not applicable to this device. MAS® DOA Total is a chemical control material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for MAS® DOA Total is analytical chemistry characterization and manufacturing specifications of the control material itself. The concentrations of the various drugs and metabolites are precisely adjusted and measured during the manufacturing process.

8. The Sample Size for the Training Set

This question is not applicable to this device. MAS® DOA Total is a manufactured control material, not an AI model that requires a training set.

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

This question is not applicable to this device for the same reason as above (not an AI model). The "ground truth" for the control material's composition is established through analytical chemistry and quality control during its production.

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Liquichek Opiate Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

Liquichek Opiate Control is prepared from human urine with added drugs of abuse, metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form for convenience.

This submission from Bio-Rad Laboratories is for a Liquichek Opiate Control, which is a quality control material for urine toxicology testing. The documentation does not describe a study involving a medical device with a "device performance" in the typical sense of diagnostic accuracy (sensitivity, specificity, AUC) or an AI algorithm. Instead, it details a 510(k) premarket notification for an in vitro diagnostic (IVD) control material. The "performance data" refers to the stability of the control material itself, not the performance of a diagnostic device it would be used with.

Therefore, many of the requested elements of your query (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test/training set, training set size, and how training ground truth was established) are not applicable to this type of submission.

Here's an adaptation of the requested table and information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

As this document describes the stability and characteristics of a quality control material, rather than a diagnostic device's performance on patient data, the concept of a "test set" in the context of diagnostic accuracy is not directly applicable.

The performance data refers to:

• Stability Studies: These involve testing the control material over time under specified conditions. The sample size would be related to the number of vials/batches tested at various time points. This specific number is not provided in the summary.
• Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin for the data is implicitly the USA, where Bio-Rad Laboratories is located. The studies are prospective in nature, as they involve monitoring the product's characteristics over time.

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

Not applicable. "Ground truth" in the sense of expert consensus on patient cases is not relevant for the stability testing of a quality control material. The 'ground truth' for the stability studies would be the scientifically established chemical stability of the analytes, measured directly in the control material using validated analytical methods.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among experts on patient diagnoses. This is not a diagnostic device study.

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

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human performance, often with and without AI assistance, in diagnostic tasks. This submission is for a quality control material.

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

No. This is not an algorithm or AI device. The "device" is a physical control material.

7. The Type of Ground Truth Used

The "ground truth" for the stability data supporting the claims would be based on analytical measurements (e.g., using validated laboratory assays) of the analyte concentrations within the control material over time and under various storage conditions. This is a direct measurement of the control material's properties, not an expert panel diagnosis or pathology.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm being trained in this context. The "training set" concept is not relevant.

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

Not applicable, as there is no training set for an AI algorithm.

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MAS Tox Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in the measurement of Benzodiazepines and Barbiturates in human serum and plasma and Tricyclic Antidepressants drugs (TCA) in human serum, plasma and urine.

Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Not Found

This document is a 510(k) clearance letter from the FDA for the MAS Tox Control device. It confirms the device's substantial equivalence to a legally marketed predicate device.

However, the document DOES NOT contain information about acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details for an AI/ML powered device.

This letter is for a Clinical Toxicology Control Material, which is a quality control product used to monitor the performance of assay conditions for measuring specific substances (Benzodiazepines, Barbiturates, Tricyclic Antidepressants). It is not an AI/ML-powered diagnostic device. Therefore, the requested information categories are not applicable to the content of this document.

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The Control Set DAT I is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.
The Control Set DAT II is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.
The Control Set DAT III is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.
The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.

Control Set DAT I is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity. Control Set DAT I contains a mixture of 10 different drugs. Drug concentrations in are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
Control Set DAT II is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity. Control Set DAT II contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
Control Set DAT III is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity. Control Set DAT III contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
Control Set Amphetamine 1000 is prepared by the quantitative addition of d-amphetamine to drug-free human urine. Preservative is added to maintain product integrity. Drug concentrations in Control Set Amphetamine 1000 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.
Control Set Amphetamine 500 is prepared by the quantitative addition of d-amphetamine to drug-free human urine. Preservative is added to maintain product integrity. Drug concentrations in Control Set Amphetamine 500 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

The provided documentation describes the Control Set DAT I, II, III, Control Set Amphetamine 1000, and Control Set Amphetamine 500 products as "Drug Mixture Control Materials." These are controls used to verify the performance of drug abuse testing systems. The "study" described is primarily focused on characterizing the control materials themselves, not a clinical study involving the device's diagnostic performance on patient samples.

Therefore, many of the typical acceptance criteria and study design elements for AI/diagnostic devices will not be applicable here. This document describes the creation and verification of the control materials.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these control sets are primarily defined by their target concentrations for various drugs, established as ±25% of the assay cutoff. The "reported device performance" in this context refers to the verification of these target concentrations using Gas Chromatography/Mass Spectrometry (GC/MS).

Note: The document states that drug concentrations are verified by GC/MS, implying that these target concentrations were successfully achieved and confirmed. Specific numerical results of this verification (e.g., actual measured concentrations and their variances) are not provided in this summary, only the target ranges.

Study Details (as applicable)

1. Sample size used for the test set and the data provenance: This document describes the preparation and verification of control materials, not a study evaluating a diagnostic device with patient samples. Therefore, there isn't a "test set" in the traditional sense of patient data. The "samples" are the control materials themselves, which are prepared from "drug-free human urine" with quantitative additions of specific drugs/metabolites. The provenance of the drug-free human urine or the origin of drug substances is not specified. It's a laboratory-prepared product.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the concentrations in the control materials is established by the quantitative addition of known amounts of drugs and then verified by GC/MS, an analytical chemistry technique. This does not involve human expert interpretation of a diagnostic outcome.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As this is not a diagnostic interpretation study, there is no adjudication process involving human experts.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to control materials for drug testing, not an AI-powered diagnostic device or a study involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. These are control materials, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the control materials is the known, quantitatively added concentrations of specific drugs/metabolites, verified by an analytical method (Gas Chromatography/Mass Spectrometry (GC/MS)).

7. The sample size for the training set: Not applicable. Control materials do not have a "training set" in the context of machine learning or diagnostic algorithm development.

8. How the ground truth for the training set was established: Not applicable.

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