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VITROS Chemistry Products CRP Slides:
For in vitro diagnostic use only.
VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/5.1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
C-reactive protein is synthesized by the liver and is one of the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections.

VITROS Chemistry Products Calibrator Kit 7:
For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.

The VITROS CRP Slide method is performed using the VITROS CRP Slides and the VITROS Chemistry Products Calibrator Kit 7 on VITROS Chemistry and Integrated Systems.
The VITROS CRP Slide is a multilayered, analytical element coated on a polyester support. The immuno-rate format for CRP is based on an enzymatic heterogeneous, sandwich immunoassay format. In this format a derivative of phosphorylcholine (PC) is covalently bound to polystyrene polymer beads and in the presence of calcium serves as a capture agent. Monoclonal anti-CRP antibody conjugated to horseradish peroxidase (HRP) serves as a signal generator.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. CRP in the sample binds to PC-linked capture beads and anti-CRP antibody labeled with horseradish peroxidase to form an insoluble sandwich complex in Incubation 1. The subsequent addition of 12 microliters of VITROS Immuno-Wash Fluid to the slide removes unbound materials from the read area, while also providing the hydrogen peroxide required for the enzyme-mediated oxidation of leuco dye.
The reflection density of the dye is measured after the addition of VITROS Immuno-Wash Fluid at the end of Incubation 2. This reflection density is directly proportional to the concentration of CRP in the sample. To determine if an adequate wash has occurred, the wash detection dye is read at 540 nm immediately after Incubation 2.

The VITROS Calibrator Kit 7 is prepared from processed human serum to which purified human C-reactive protein, inorganic salts, and preservatives have been added.
The human blood products provided as components of VITROS Calibrator Kit 7 have been tested at the individual donor level and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to HCV, and antibody to HIV using FDA approved methods.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance characteristics rather than explicit "acceptance criteria" with pass/fail thresholds in a formal table. However, we can infer the criteria from the studies conducted.

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

• Sample Size: 98 to 103 human serum samples were used for the method comparison study.
• Data Provenance: The document states "Human serum samples were tested." The country of origin is not specified, but the context implies it was likely from a clinical setting. It is a retrospective dataset as it involves testing existing samples.

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

This information is not explicitly provided. The "ground truth" for the test set is established by comparing the new device's readings against a "predicate method" (VITROS Chemistry Products CRP assay traceable to ERM-DA472). The document describes this predicate as generating the reference measurements, not a panel of experts.

4. Adjudication Method for the Test Set:

Not applicable. The study compares the new device's measurements to a predicate device's measurements, not to expert consensus.

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

Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement, not an AI or imaging device requiring human reader interpretation or assistance.

6. Standalone Performance:

Yes, the studies described (Method Comparison, Limits of Blank, Detection, and Quantitation, Linearity, Analytical Range) directly assess the standalone performance of the VITROS Chemistry Products CRP Slides without human-in-the-loop performance. The results are generated solely by the device and its associated systems.

7. Type of Ground Truth Used:

The ground truth used for performance evaluation is comparative measurement against a legally marketed predicate device (VITROS Chemistry Products CRP assay traceable to ERM-DA472), which itself has established performance characteristics and traceability to a recognized international reference material (ERM-DA472). In essence, it's a reference measurement from an established method.

8. Sample Size for the Training Set:

The document does not mention a "training set." This type of in vitro diagnostic device typically undergoes analytical validation studies (as described) rather than machine learning model training.

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

Not applicable, as there is no training set for this device as described. Its performance is evaluated through direct analytical studies.

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