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For in vitro diagnostic use only.

For the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin), using the VITROS 5600 Integrated System. The VITROS CA 19-9 test is to be used to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The VITROS CA 19-9 test can be used to monitor the disease status in patients with confirmed pancreatic cancer who show measurable CA 19-9 values over the course of their disease. Serial CA 19-9 test results should be used in conjunction with all other available clinical and laboratory data before a medical decision is determined.

The VITROS Immunodiagnostic Products CA 19-9 assay (test) is performed using the VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack and VITROS CA 19-9 Calibrators on the VITROS 5600 System.

An immunometric immunoassay technique is used, which involves the simultaneous reaction of 1116-NS-19-9 defined antigen present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-1116-NS-19-9 defined antigen) bound to Streptavidin. In a second incubation a Horseradish Peroxidase (HRP)- labelled antibody conjugate (Mouse monoclonal anti-1116-NS-19-9 defined antigen) binds to the immobilized 1116-NS-19-9 defined antigen. Unbound materials are removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of conjugate bound is directly proportional to the concentration of 1116-NS-19-9 defined antigen present in the sample.

VITROS Immunodiagnostic Products CA 19-9™ Reagent Pack contains:
1 reagent pack containing:

• 100 coated wells (antibody, mouse monoclonal anti-1116-NS-19-9 defined antigen, binds >49 U 1116-NS-19-9 defined antigen/well)
• 13.4 mL assay reagent (buffer containing bovine gamma globulin and antimicrobial agent)
• 20.0 mL conjugate reagent (HRP-mouse monoclonal anti-1116-NS-19-9 defined antigen, binds ≥326 U 1116-NS-19-9 defined antigen/mL) in buffer with bovine serum albumin, bovine gamma globulin and antimicrobial agent.

VITROS CA 19-9 Calibrator contains:

• 1, 2, and 3 (OC 1116-NS-19-9 defined antigen in buffer with bovine serum albumin and antimicrobial agent, 1.75 mL); nominal values 15; 60 and 700 U 1116-NS-19-9 defined antigen/mL
• 24 calibrator bar code labels (8 for each calibrator)

This document describes the non-clinical performance studies conducted for the VITROS CA 19-9 assay to demonstrate its safety and effectiveness. The information focuses on analytical performance characteristics rather than clinical diagnostic accuracy studies involving human experts for ground truth, which are typically found in studies for AI/ML-based medical devices or imaging diagnostics.

Since this device is an in-vitro diagnostic (IVD) assay for measuring a tumor-associated antigen (CA 19-9) in human serum and plasma, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily based on established analytical performance parameters, not on human-expert-validated diagnostic accuracy. Therefore, several points from your request (e.g., number of experts, adjudication methods, MRMC studies, human-in-the-loop performance) are not directly applicable or reported in this type of submission.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents validation studies against established guidelines (e.g., CLSI documents) and compares the modified device's performance to its predicate. The nature of these acceptance criteria is based on quantitative analytical performance characteristics.

2. Sample Sizes Used for the Test Set and Data Provenance

The "test set" here refers to the samples used in the analytical validation studies. These are not human-interpreted images or clinical datasets in the AI/ML sense but rather biological samples.

• Stability Studies: Four runs on each of 3 lots at monthly intervals for long-term; 3 lots up to 12 weeks for on-board stability. Number of samples not explicitly stated but implies sufficient runs to validate stability claims.
• Precision: 6 precision fluids; 2 replicates, 2 runs/day for 20 days (total 80 data points per fluid).
• Detection Capability (LoB): 4 endogenous fluids with no CA19-9; 2 replicates, 2 runs/day for 5 test days (20 reps/fluid) x 4 fluids = 80 replicates x 3 lots = 240 total replicates.
• Detection Capability (LoD/LoQ): 5 samples; 6 replicates, 2 runs/day for 5 test days (60 reps/fluid) x 5 fluids = 300 replicates x 3 lots = 900 total replicates.
• Linearity: 16 levels in the test panel; 5 replicates of each level run on 3 reagent lots over 2 days.
• Matrix Comparison: 41 specimens for Li-Hep vs. Serum and 41 specimens for EDTA vs. Serum.
• Analytical Specificity (Interferences): Tested at CA 19-9 concentrations of ~5.0 U/mL and ~50.0 U/mL. Specific sample numbers for this testing are not given but are implied to be within CLSI guidelines.
• Expected Values (Reference Interval): 60 normal blood donors.
• Method Comparison: 118 patient serum samples.

Data Provenance: The document does not explicitly state the country of origin for the samples or if they were retrospectively or prospectively collected. The studies appear to be laboratory-based analytical validation studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of IVD analytical device validation. The "ground truth" for the performance of a CA 19-9 assay is established by the known concentration of the analyte in control samples, reference materials, or by comparison to a well-validated predicate method, not by human expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of IVD analytical device validation. Adjudication is typically used for reconciling disagreements among human experts in diagnostic imaging interpretation or clinical decision-making.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

An MRMC study is not applicable to this device. This type of study assesses how human readers' diagnostic accuracy changes with or without AI assistance, which is for AI/ML-based diagnostic devices (e.g., imaging AI). This device is a quantitative immunoassay.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable in the context of an IVD assay. The "algorithm" is the biochemical reaction and the instrument's measurement system. The device's "standalone" performance is what these non-clinical analytical studies demonstrate. The results are quantitative measurements of the CA 19-9 antigen, not classifications or detections that would then be presented to a human for interpretation.

7. The Type of Ground Truth Used

• Analyte Concentration: For precision, detection capability, linearity, known interferences, and dilution, the "ground truth" is based on the known or reference concentrations of CA 19-9 in control materials, spiked samples, or reference standards.
• Comparative Method: For method comparison, the "ground truth" is established by the results from the legally marketed predicate device (VITROS CA 19-9 assay, K052889).
• Normal Population Reference: For expected values, the "truth" is established by determining the range of values observed in a healthy, "normal" population.

8. The Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning. For an IVD assay, the development process involves reagent formulation, instrument calibration, and optimization using iterative testing and refinement, not a distinct "training set" of data in the AI/ML sense. The studies described are validation activities for the final device.

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

As there is no "training set" in the AI/ML sense for this IVD, this question is not applicable. The "ground truth" for developing and calibrating an IVD like this would be established through highly controlled laboratory preparations of samples with known concentrations of the target analyte, often traceable to international standards if available. Calibration itself establishes the relationship between the measured signal and the concentration of the analyte.

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