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The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on manual, automatic, and semi-automatic analyzers. The Audit™ MicroCV™ RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only".

The Audit™ MicroCV™ RF/CRP Linearity Set is a 5 level quality control solution set containing C-reactive protein and Rheumatoid Factor as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of RF and CRP. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

This submission (K101226) is for the Audit™ MicroCV™ RF/CRP Linearity Set, a quality control material used to confirm calibration, linear operating range, and reportable range for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes.

Based on the provided document, the device primarily focuses on demonstrating stability (open-vial and shelf-life) and chemical equivalence to predicate devices, rather than clinical performance against a disease state or diagnosis. As such, the concept of "acceptance criteria" and "device performance" in the traditional sense of diagnostic accuracy (sensitivity, specificity, etc.) with a test set and ground truth established by experts is not directly applicable.

Instead, the acceptance criteria for this device revolve around its stability and its ability to function as a linearity/quality control material. The study therefore focuses on demonstrating these aspects.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core "performance" demonstrated for this device relates to its stability and its intended function as a linearity set.

Detailed Information on Studies:

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

   • The document does not specify exact sample sizes (e.g., number of vials, number of runs) for the stability studies. It only states that "Stability studies have been performed."
   • The data provenance is internal to Aalto Scientific, Ltd. (USA), as implied by the statement "All supporting data is retained on file at Aalto Scientific. Ltd." The studies are prospective in nature for shelf-life (real-time studies are ongoing) and likely prospective for open-vial stability.

2. 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):

   • This is a quality control material where the "ground truth" is defined by the expected stability parameters (e.g., maintained concentration within a specified range over time) and the linearity of the prepared levels.
   • Therefore, the concept of "experts establishing ground truth for a test set" in a clinical diagnostic sense, is not applicable. The performance is determined by established analytical methods and specifications, likely overseen by qualified laboratory personnel and chemists/biochemists, rather than clinical experts interpreting results.

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

   • Not applicable as this is not a diagnostic device requiring human interpretation or adjudication of results against a clinical ground truth. Performance is assessed through analytical testing against predefined specifications.

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 device is a quality control material, not an AI-assisted diagnostic tool.

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

   • Not applicable. This device is a biochemical reagent, not an algorithm.

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

   • The "ground truth" here is the analytical specification and expected behavior of the linearity set. For stability, the ground truth is that the analyte concentrations remain within acceptable limits over time. For linearity, the ground truth is that the five levels will produce a linear response when measured on an appropriate analytical instrument. These are determined by the manufacturer's internal standards and established analytical chemistry principles.

7. The sample size for the training set:

   • Not applicable. This is a quality control material, not a machine learning algorithm that requires a training set. The product is manufactured according to a set formulation and tested for consistency and stability.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

Summary of the Study:

The primary study detailed in the K101226 summary is a stability study. This study demonstrated that the Audit™ MicroCV™ RF/CRP Linearity Set is stable for:

• 5 days after reconstitution when stored tightly capped at 2-8°C (open vial stability).
• 19 months when stored unopened at 2-8°C (shelf life).

The summary explicitly states: "All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows: Open Vial Stability: Once a vial has been reconstituted, all analytes will be stable for 5 days when stored tightly capped at 2-8 C. Shelf Life: 19 months at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product."

The design of the product, with five levels demonstrating a linear relationship through dilution, inherently defines its function as a linearity set. The "performance" in this context is its ability to reliably fulfill this function and maintain its properties over time. The submission demonstrates substantial equivalence primarily through comparing its intended use, analytes, matrix, and physical form to existing predicate devices (Bio-Rad Liquichek Lipids Control, Audit™ MicroCV™ General Chemistry Linearity Set, and LiniCAL Calibration Verifier RF/CRP).

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