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ACCURUN™ 146 CMV IgM Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Cytomegalovirus (CMV). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 146 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to CMV in human serum and plasma.

ACCURUN™ 146 CMV IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to CMV, but is nonreactive for Hepatitis B Surface Antigen (HBsAg) and antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents), and 0.1% ProClin™ as preservative. This control is supplied as 1 x 1 ml or 1 x 5 ml vial. ACCURUN™ 146 should be stored frozen at -10°C or colder. Once opened, ACCURUN™ 146 should be stored at 2-8°C and discarded after 60 days.

The provided document describes the ACCURUN™ 146 CMV IgM Positive Control, a human blood-based single analyte run control for detecting IgM antibodies to Cytomegalovirus (CMV). However, it does not explicitly state acceptance criteria in a quantitative manner or provide a detailed study report with performance metrics against pre-defined criteria.

Based on the available text, here's a breakdown of the information and what cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document describes the types of stability studies performed and the conclusions drawn, but lacks specific quantitative acceptance criteria (e.g., "signal not to drop by more than X% after Y days at Z temperature"). The "reported device performance" is a summary of the conclusions rather than hard data points.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical laboratory evaluations were performed at BBI and two external sites, including one blood bank and a clinical laboratory" and "three manufactured ACCURUN™ 146 lots." However, the number of individual control vials or test events in these evaluations is not provided.
• Data Provenance: The studies were conducted at "BBI and two external sites, including one blood bank and a clinical laboratory." The countries of origin for these labs are not specified. The studies appear to be prospective evaluations of the device's stability and performance in a usability context.

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

• Not applicable. This device is a positive control, meaning its purpose is to provide a known positive signal for CMV IgM. It does not output a diagnostic result that requires expert interpretation or ground truth establishment in the traditional sense of a diagnostic test. The "ground truth" for the control itself is its known composition (human serum/plasma containing IgM antibodies to CMV). The evaluations focused on the control's stability and consistency in producing an expected signal, not on its diagnostic accuracy against patient samples.

4. Adjudication Method for the Test Set:

• Not applicable. There was no "test set" in terms of patient samples requiring diagnostic interpretation and adjudication. The studies evaluated the stability and performance of the control itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is not applicable to a positive control device. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images or data, and the comparison is between human performance with and without AI assistance. The ACCURUN™ 146 is a control material, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This device is a biological control material, not an algorithm.

7. Type of Ground Truth Used:

• For the composition of the control itself, the ground truth is the known presence of IgM antibodies to Cytomegalovirus (CMV) in the human serum or plasma used to manufacture it, along with confirmed non-reactivity for other specified viruses (HBsAg, HIV 1/2, HTLV I, HCV). The studies assessed the control's ability to maintain its intended characteristics (stability, consistent signal) over time and under various conditions.

8. Sample Size for the Training Set:

• Not applicable. This device is a biochemical control, not an AI model that requires a training set.

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

• Not applicable. As above, no training set is relevant for this product.

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