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The IMMAGE Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.

The IMMAGE Immunochemistry System Prealbumin (PAB) Reagent, in coniunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.

Here's a breakdown of the acceptance criteria and study details for the IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets for accuracy, stability, or precision. Instead, it presents performance data and implies that these results demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are inferred as aligning with the predicate's performance and generally accepted good laboratory practices for these types of assays.

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

• Sample Size (Method Comparison): 124 (samples)
• Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The samples were "Serum."

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

This information is not provided in the document. For an immunochemistry system like this, the "ground truth" for method comparison is typically established by measurements from a reference method or a predicate device. There isn't typically "expert adjudication" in the same way there would be for image-based diagnostics.

4. Adjudication Method for the Test Set:

Not applicable in the traditional sense for this type of device. The "ground truth" for comparison is the result obtained from the Beckman Immunochemistry System PAB Prealbumin Reagent (on ARRAY® System), which is the predicate device. Therefore, no expert adjudication process (like 2+1 or 3+1) is mentioned or implied.

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

No. This is an immunochemistry assay, not an image-based diagnostic that involves human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

Yes, implicitly. The device (IMMAGE Immunochemistry System Prealbumin Reagent) is an automated system for quantitative determination. Its performance is measured directly against a predicate device and through stability and precision studies. There is no "human-in-the-loop" component in the operation or interpretation of the numerical results from this system.

7. The Type of Ground Truth Used:

• Method Comparison: The "ground truth" was established by measurements obtained from the predicate device, specifically the "Beckman Prealbumin Reagent (PAB) on the ARRAY® Systems." This is a comparative measurement against an already marketed and accepted device.
• Stability/Precision: The ground truth for these studies is the inherent performance of the device under controlled conditions, demonstrating reproducible and stable results. This is established through internal testing protocols.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This is a reagent and assay system, not a machine learning or AI model that requires a distinct "training set." The development of the assay itself involves optimization and validation, but not in the sense of training a discrete algorithmic model with a specific dataset.

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

Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this type of device. The development and validation of the reagent and assay involve standard laboratory procedures and chemical/biological principles.

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