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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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