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Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedure, specifically Troponin-I, CK-MB and Myoglobin.

Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).

This document is a 510(k) summary for the Dade® TRU-Liquid™ Cardiac Control, which is a quality control material. The document largely focuses on claiming substantial equivalence to a previously cleared device (K981622) rather than presenting a detailed study with specific acceptance criteria and performance data for the current device.

Therefore, the requested information, specifically regarding detailed acceptance criteria and a study proving the device meets those criteria, is not present in the provided text. The document states that the device "is substantially equivalent in terms of intended use and safety and effectiveness to the current Dade® TRU-Liquid™ Cardiac Control manufactured by Dade Behring, previously cleared under Document Control No., K981622." This implies that the current device is considered acceptable because a previous version was, and thus no new, detailed acceptance criteria or performance study for this specific 510(k) submission are provided.

However, based on the content and common practices for quality control materials, we can infer some general aspects and state what is missing:

Inferred Information and Missing Details:

1. Table of Acceptance Criteria and Reported Device Performance: This specific table is not provided in the document. For a quality control material, acceptance criteria would typically involve:

   • Analyte Concentration Stability: The control material must maintain stable target concentrations for specific cardiac markers (Troponin-I, CK-MB, Myoglobin) over its shelf-life and in-use period.
   • Assigned Value Accuracy: The measured values of the control material on various diagnostic platforms should fall within a predefined range around the assigned target values.
   • Within-lot and Lot-to-lot Reproducibility/Precision: The control material should produce consistent results within a single lot and across different manufacturing lots.
   • Matrix Compatibility: The control material's matrix should behave similarly to patient samples across different assay methods.

   The document does not report specific performance values against such criteria for this 510(k) submission. It relies on the substantial equivalence to a previous device.

2. Sample Size Used for the Test Set and Data Provenance: This information is not provided. If a new study were conducted, it would typically involve:

   • Test Set Size: Likely a series of runs or measurements of the control material over time and across multiple instruments/reagents.
   • Data Provenance: Not specified, but generally, for such controls, data would be laboratory-generated, possibly from multiple sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: This is not applicable in the traditional sense for a quality control material. The "ground truth" for a quality control material is its assigned target value, which is established through rigorous characterization methods by the manufacturer, often using reference methods or certified reference materials, and then verified through collaborative studies or extensive in-house testing. It does not typically involve expert consensus on individual "cases."

4. Adjudication Method for the Test Set: Not applicable for this type of device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is relevant for diagnostic imaging or interpretation devices where human readers are interpreting cases. A quality control material like this does not involve human readers in that capacity.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Not applicable. This device is a physical reagent used to verify the performance of diagnostic instruments, not an algorithm.

7. Type of Ground Truth Used: For a quality control material, the "ground truth" (or assigned value) is established through reference methods, certified reference materials, and/or extensive independent laboratory testing and statistical analysis. The document does not explicitly state how the ground truth for this version of the control was established, but it would align with these general principles for quality control materials.

8. Sample Size for the Training Set: Not applicable. This is a quality control material, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established: Not applicable. (See point 8).

In summary, the provided 510(k) document is a declaration of substantial equivalence for a quality control material. It does not contain the detailed performance study data, acceptance criteria, or specifics about ground truth establishment that would be expected for a novel diagnostic device or AI/ML product. The basis for its clearance is its similarity to a previously approved device (K981622).

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Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance quarrer control accession the control of accuracy and precision of a laboratory's cardiac market procedures, specifically Troponin I, CK-MB, and Myoglobin.

Liquid Tri-Level Cardiac Control

The provided text is a 510(k) summary for a medical device called "Dade® TRU-Liquid™ Cardiac Control." This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic or therapeutic device.

Therefore, many of the requested categories (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable or detailed in this type of regulatory submission for a quality control material.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the format of a table with specific acceptance criteria (e.g., precision limits, accuracy targets) and corresponding reported performance for the TRU-Liquid Cardiac Control itself. The document's primary focus is on demonstrating substantial equivalence to a predicate device (Liquichek Cardiac Markers Control). This implies that the performance of the new device is expected to be comparable to this legally marketed predicate.

The document states: "The proposed Dade® TRU-Liquid™ Cardiac Control is substantially equivalent in terms of intended use and safety and effectiveness to the Liquichek Cardiac Markers Control manufactured by Bio-Rad Laboratories, previously cleared under Document Control No., K961828."

This "substantial equivalence" is the overarching acceptance criterion, evaluated by comparing the new device's characteristics and intended use to those of the predicate. The performance data that supports this would typically be found in the full 510(k) submission, not necessarily in this summary document.

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

Not applicable. This document does not describe a clinical performance study with a test set of patient samples. The "test" for this device likely involved laboratory characterization and comparison to the predicate, but specific sample sizes for such internal testing are not provided in this summary.

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

Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable for the same reason as above.

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

No. An MRMC study is relevant for devices involving human interpretation of clinical data (e.g., imaging devices). This is a quality control material.

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

Not applicable. This device is a quality control material, not an algorithm or an automated system.

7. The Type of Ground Truth Used:

Not applicable in the sense of patient outcomes, pathology, or expert consensus on clinical findings. For a quality control material, the "truth" is typically established through precise analytical methods and characterization of the material itself (e.g., target analyte concentrations determined by reference methods). The document implies that the "truth" for demonstrating equivalence relies on comparing the new device's characteristics to those of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary of available information:

• Device Type: Quality Control Material (Liquid Tri-Level Cardiac Control) for Troponin I, CK-MB, and Myoglobin.
• Regulatory Basis: Substantial equivalence to a legally marketed predicate device (Liquichek Cardiac Markers Control, K961828).
• Intended Use: Assayed quality control material in clinical laboratory quality assurance for accuracy and precision of cardiac marker procedures.
• Study described: No specific clinical or performance study with defined acceptance criteria and performance results is detailed within this summary. The entire 510(k) process is based on demonstrating the device's equivalence to a predicate, which implies that appropriate testing was performed to support this claim, but the details are not in this public summary.

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Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac marker procedures.

Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).

This document is a 510(k) summary for a medical device called "Dade® TRU-Liquid™ Cardiac Control." It is a quality control material intended for use in clinical laboratory quality assurance programs to assess the accuracy and precision of cardiac marker procedures. The document states that the device is "substantially equivalent" to a previously cleared predicate device, the "Liquichek Cardiac Markers Control" manufactured by Bio-Rad Laboratories (K961828).

Based on the provided text, the following information can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., specific ranges for accuracy, precision, or recovery) or provide detailed performance data for the Dade® TRU-Liquid™ Cardiac Control device.

Instead, the core of the submission is a demonstration of substantial equivalence to a predicate device. This means the device is considered acceptable if it performs comparably to the predicate device for its intended use. The document affirms this substantial equivalence, but it does not present the direct experimental results that led to that conclusion for the new device.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The document refers to the predicate device (K961828) which would have had its own testing, but details on the testing of the Dade® TRU-Liquid™ Cardiac Control itself are absent from this summary.

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

This information is not applicable and not provided. The device is a quality control material, not a diagnostic device requiring expert interpretation of results to establish ground truth. Its "truth" is based on the known concentrations of analytes within the control material, which are then used to assess other diagnostic assays.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used for diagnostic devices where human interpretation or consensus is required for complex cases.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting medical images or data. The Dade® TRU-Liquid™ Cardiac Control is a quality control material for laboratory instruments/assays.

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

No, a standalone performance study (in the context of AI algorithms) was not done. This device is not an AI algorithm. Its performance is evaluated through its stability, homogeneity, and accuracy of assayed values when used to calibrate or check other diagnostic assays.

7. The Type of Ground Truth Used

For a quality control material like this, the "ground truth" would be the assigned or assayed values (known concentrations) of the cardiac markers within the control material itself. These values are typically established through rigorous analytical methods, often by the manufacturer using reference methods or certified reference materials. The purpose of the control is then to ensure that clinical laboratory instruments/assays accurately measure these known concentrations.

8. The Sample Size for the Training Set

This information is not applicable and not provided. A "training set" refers to data used to train machine learning models. This device is not an AI/ML device.

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

This information is not applicable and not provided, as there is no training set for this type of device.

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