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CBC-4K™ is a tri-level hematology control designed to document and monitor values obtained from Cell-Dyn ® hematology instruments.

CBC-4K™ is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes and platelets suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of Cell-Dyn® Hematology Systems. CBC-4K™ is available in three levels of measured constituents and is run in the same manner as patient specimens.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CBC-4K™ Hematology Control:

The provided document describes a hematology control device, not an AI or imaging device, which means many of the requested criteria for AI/imaging studies (like experts, adjudication, MRMC studies, effect size, standalone performance, training sets, etc.) are not applicable in this context. The acceptance criteria here pertain to the stability and performance of a laboratory reagent for quality control.

Acceptance Criteria and Reported Device Performance

Study Details (as inferable from the text)

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

   • Sample Size: Not explicitly stated. The document refers to "studies" and "performance data" without specifying the number of samples or runs.
   • Data Provenance: Not specified, but given it's a laboratory control, it would have been generated in a controlled laboratory setting (likely R&D Systems' own lab). It is implicitly prospective in nature, as new batches of the control would be tested for stability over time.

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

   • Not Applicable. For a hematology control, "ground truth" is established by the well-defined properties of the control material (e.g., target values for cell counts, hemoglobin, etc.) measured against a reference method or validated instrument. It does not involve human expert interpretation in the same way an imaging study would.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication is not relevant for the performance assessment of a laboratory control. The performance is measured objectively against predefined analytical targets and stability parameters.

4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This type of study is for evaluating human performance, often with and without AI assistance, and is not relevant for a laboratory control.

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

   • Not Applicable. This is a physical reagent, not an algorithm. Its "standalone" performance refers to its intrinsic chemical and biological stability, which was indeed evaluated.

6. The Type of Ground Truth Used:

   • The "ground truth" here is the expected values and stability characteristics of the hematology control, which are determined through rigorous internal testing against established laboratory standards and reference methods. The performance is measured against these predetermined target ranges and the expected duration of stability.

7. The Sample Size for the Training Set:

   • Not Applicable. This device is a control reagent, not an AI model requiring a training set.

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

   • Not Applicable.

Summary Specific to K970331:

The document focuses on demonstrating that the CBC-4K™ Hematology Control is substantially equivalent to a predicate device (CBC-3K™) and that its stability performance meets the required criteria for its intended use as a quality control reagent for Cell-Dyn® hematology instruments. The key performance evaluation here is stability, ensuring that the control material maintains its specified characteristics over its shelf life and open-vial period. The assessment is purely analytical and objective, comparing measured values to established target ranges and timeframes.

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