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Liquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, preservatives and stabilizers. The control is provided in liquid form for convenience. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

Here's an analysis of the provided 510(k) summary for the Liquichek Immunology Control, structured according to your request:

Acceptance Criteria and Device Performance

This 510(k) summary describes a quality control material, not a diagnostic device that performs interpretations. Therefore, the "device performance" relates to its stability and ability to maintain its intended properties over time, rather than diagnostic accuracy metrics like sensitivity or specificity.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "Acceptance Criteria were met to support the product claims as follows." This confirms that the reported performance meets the established acceptance criteria for stability.

Study Details

Given that the device is a quality control material and not an AI-powered diagnostic tool, many of the requested study details (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable or relevant in the traditional sense. The studies performed focused on product stability.

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

• Sample Size for Test Set: The document does not specify an exact "sample size" in terms of number of patient samples, as this is a quality control material. Instead, it refers to "a representative sampling of this lot of product" used for value assignment and stability studies.
• Data Provenance: The studies were conducted by "the manufacturer and/or independent laboratories." No specific country of origin is mentioned for the data, but the manufacturer (Bio-Rad Laboratories) is based in Irvine, California, USA. The stability studies were prospective in nature, as they tracked the product's performance over time.

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. For a quality control material, "ground truth" refers to the expected values and stability characteristics. These are established through scientific testing and adherence to manufacturing specifications, rather than expert interpretation of a diagnostic outcome. The "value assignment" process involves replicate analyses by the manufacturer and/or independent laboratories using manufacturer-supported reagents.

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

• Not Applicable. Adjudication methods are typically used in studies involving human interpretation or uncertain diagnostic outcomes. For stability testing of a QC material, the "ground truth" (stability profile) is determined by objective laboratory measurements against set specifications, not by expert consensus or 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 a quality control material, not an AI diagnostic device, so MRMC studies are irrelevant.

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

• Not Applicable. The device is a physical quality control material, not an algorithm.

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

• For stability studies: The "ground truth" is defined by pre-established scientific and manufacturing specifications for acceptable analyte concentration ranges and stability profiles over time and under various storage conditions. The studies verified that the material's measured analyte levels and other characteristics remained within these specified ranges throughout the claimed stability periods.
• For value assignment: The ground truth consists of "mean values and the corresponding ±3SD ranges printed in the instructions for use," derived from "replicate analyses" using manufacturer-supported reagents.

8. The sample size for the training set

• Not Applicable. This is a quality control material; it does not involve AI or machine learning algorithms that require a "training set."

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.

Liquichek™ Immunology Control is prepared from human serum with added serum proteins, constituents of animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.

Here's a breakdown of the acceptance criteria and study information 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 document does not explicitly state the sample size used for the stability studies (test set). It mentions "Stability studies have been performed," but does not provide details on the number of batches, vials, or measurements taken. The data provenance is also not specified. It is likely that the testing was conducted at Bio-Rad Laboratories (the submitter and manufacturer) in Irvine, California. The studies are described as "real-time studies will be ongoing to support the shelf life," suggesting a prospective nature for the shelf-life portion, while the open and closed vial stability studies likely involved specific testing periods to establish those claims.

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

This information is not applicable to this device and study type. The "ground truth" for a quality control material like Liquichek™ Immunology Control is its stability over time under specified conditions, determined by analytical testing methods to measure analyte concentrations. It does not involve expert interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable to this device and study type. Clinical adjudication methods (like 2+1, 3+1) are used for studies involving subjective interpretations (e.g., medical imaging), which is not the case for a quality control material demonstrating analytical stability.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is designed to assess the impact of a device (often AI-based) on human reader performance in diagnostic tasks, which is not relevant for an immunology quality control product. The purpose of this submission is to demonstrate the stability and substantial equivalence of the quality control material itself.

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

No, a standalone (algorithm only) performance study was not done, as this product is not an algorithm or AI-driven diagnostic device. The performance refers to the stability of the control material's analytes.

7. The Type of Ground Truth Used

The "ground truth" for the stability studies is established through analytical testing methods to quantify the concentration of each analyte in the control material over time under various storage conditions. The acceptable range for these concentrations (what constitutes "stable") would be defined internally by Bio-Rad Laboratories based on established analytical performance specifications. It is a measurement-based ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. This device is an immunology control product, not an algorithm that requires a "training set" in the context of machine learning or AI.

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

This information is not applicable, as there is no "training set" for this device.

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Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.

Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immunoqlobulin and other proteins in serum. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. Qualitrol Immunology Control will be offered in three levels of 5.0 mL fill vials.

This submission describes a quality control material rather than a diagnostic device, therefore, the typical acceptance criteria and study designs are not directly applicable in the same way they would be for an AI-powered diagnostic tool. The "performance" being evaluated is its suitability as a control material, primarily by comparing its characteristics to a legally marketed predicate device.

Here's how the provided information relates to your request, with explanations for where certain criteria are not applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

For this type of device, the "acceptance criteria" are implied by the characteristics of the predicate device and the manufacturer's claim of "substantial equivalence." The reported "device performance" is a comparison of these characteristics.

Explanation of "Acceptance": The FDA's letter (K992770) explicitly states: "We have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination serves as the "acceptance" for marketing the product. The minor differences (e.g., number of analytes, lyophilized vs. liquid form) were deemed not to raise new questions of safety or effectiveness.

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

• Sample Size: Not applicable in the traditional sense of a diagnostic test set. This is a quality control material, and the "test" involved comparing its formulation and intended use characteristics against a predicate device. Performance would typically be assessed during internal validation of its stability, analyte levels, and consistency, but those details are not provided in this 510(k) summary.
• Data Provenance: Not explicitly stated. The comparison is against a commercially available predicate device (LIQUICHEK IMMUNOLOGY CONTROL, BIO-RAD Laboratories K-945651). The information provided is a comparative analysis of product characteristics.

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

• Not applicable. "Ground truth" in the context of a quality control material refers to the established target values for the analytes within the control. This is typically determined through rigorous analytical methods and inter-laboratory studies conducted by the manufacturer, rather than by human experts establishing diagnostic "ground truth" as in an imaging study. The provided document focuses on the equivalence of the control's characteristics to another control, not its accuracy in mimicking a clinical condition.

4. Adjudication method for the test set

• Not applicable. There was no "test set" requiring adjudication in the diagnostic sense. The comparison was a direct assessment of physical and functional characteristics against a predicate device.

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 immunology control, not an AI-assisted diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI component is relevant.

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

• Not applicable. This device is an immunology control, not an algorithm.

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

• For this device, "ground truth" (if we stretch the definition) would refer to the assigned values of the analytes within the control material, and the physical/chemical properties that define it as a suitable control. These are established through manufacturing processes, analytical testing, and stability studies, not expert consensus, pathology, or outcomes data related to patient diagnosis. The document primarily uses the characteristics of the predicate device as a benchmark.

8. The sample size for the training set

• Not applicable. This is a quality control material, not a machine learning model. There is no concept of a "training set" for its development or validation as described in this document.

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

• Not applicable. As above, there is no training set for this product.

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

Liquichek Immunology Control is prepared from human serum with added serum proteins and stabilizers. The control is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

The provided document is a 510(k) summary for the Bio-Rad Liquichek Immunology Control. It describes the device, its intended use, and claims substantial equivalence to an existing device. However, it does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics such as sensitivity, specificity, or accuracy that would be derived from a performance study.

Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on regulatory submission and demonstrating equivalence based on technological characteristics rather than providing performance study results.

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The Liquid Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Abbott Liquid Immunology Control. The letter indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, the document does not contain the acceptance criteria or the study details for the Abbott Liquid Immunology Control.

Therefore, I cannot provide the requested information. The text is a regulatory approval letter, not a scientific study report or a summary of performance data.

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As a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents.

The KAMIYA Immunology Control is a liquid-stable, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents. Two levels of the KAMIYA Immunology Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to CV and HIV. The assigned values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The product is stable for at least 1 year (unopened) and 1 month (after opening).

The Kamiya Biomedical Company's Immunology Control is a liquid-stable, human serum-based, assayed control intended for monitoring the performance of immunoturbidimetric assays for various constituents.

1. Acceptance Criteria and Reported Device Performance:

The document states that the safety and effectiveness of the KAMIYA Immunology Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202). The key acceptance criteria and reported performance are based on comparison to this predicate device.

2. Sample Size and Data Provenance:

The document does not explicitly state the sample size used for the performance evaluation. It mentions "10 analytes tested," implying that the comparison for precision and reaction characteristics was performed across these analytes.

The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission, it would typically involve prospective testing conducted by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information about the number of experts used or their qualifications for establishing ground truth as it relates to the performance study. The ground truth for the assigned values is stated to be traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum, which implies established, standardized reference methods and materials are used.

4. Adjudication Method:

The document does not mention an adjudication method for a test set in the context of expert consensus or disagreement. The evaluation relies on direct comparisons of performance characteristics against a predicate device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic control, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.

6. Standalone Performance Study:

A standalone performance study was performed in the sense that the KAMIYA Immunology Control's own precision and reaction characteristics were measured and then compared to those of the predicate device to demonstrate substantial equivalence. The "algorithm" here refers to the function of the control itself, rather than a software algorithm.

7. Type of Ground Truth Used:

The ground truth for the assigned values of the control is established by traceability to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. For the performance evaluation (precision and reaction characteristics), the "ground truth" is effectively derived from the established performance of the legally marketed Sigma Immunology Control (K851202), against which the new device is compared for substantial equivalence.

8. Sample Size for the Training Set:

This concept is not applicable. The device is a diagnostic control, not a machine learning model that requires a training set.

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

This concept is not applicable as there is no training set for this device.

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