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The ADVIA Centaur CA 15-3 assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 15-3 in human serum using the ADVIA Centaur® System. When used in conjunction with other clinical and diagnostic procedures, serial testing with the ADVIA Centaur CA 15-3 assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated patients with Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients. This assay is not intended for use on any other system.

The ADVIA Centaur CA 15-3 assay is a fully automated, two-step sandwich immunoassay using direct, chemiluminescent technology. The Lite Reagent is composed of the monoclonal mouse antibody, DF3, specific for CA 15-3, labeled with acridinium ester. The Conjugate Reagent is composed of the monoclonal mouse antibody 115D8, specific for CA 15-3, labeled with fluorescein. The Solid Phase is composed of purified monoclonal mouse capture antibody, which is covalently coupled to paramagnetic particles. The sample is incubated with both Conjugate Reagent and Solid Phase simultaneously for 20 minutes. After incubation, the immuno-complex is washed and the Lite Reagent is added, incubated for an additional 20 minutes and then washed again. The measured chemiluminescence is directly proportional to the quantity of CA 15-3 antigen in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ADVIA Centaur CA 15-3 Immunoassay:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against strict acceptance criteria as might be found in a full Design Verification Report. Therefore, some of the requested information (like specific quantitative acceptance criteria or detailed study methodologies for all performance aspects) is not fully elaborated in this summary. The core of the equivalence demonstration is a correlation study.

Acceptance Criteria and Study Details for ADVIA Centaur CA 15-3 Immunoassay

1. Table of Acceptance Criteria and Reported Device Performance

• Monitoring course of disease and therapy in metastatic breast cancer patients.
• Detection of recurrence in previously treated Stage II or Stage III breast cancer patients. | Result: Meets the intended use (as stated in the 510(k) clearance document). |
  | Format | Similar to predicate (Immuno-1 CA 15-3 kit). | Result: Fully automated, two-step sandwich immunoassay. Differs mainly in signal system (chemiluminescence vs. alkaline phosphatase). |
  | Performance Characteristics | Similar to predicate (Immuno-1 CA 15-3 kit). | Result: Claimed to be similar, with the correlation study providing the primary evidence for this similarity in measurement. |
  | Results | Similar to predicate (Immuno-1 CA 15-3 kit). | Result: Quantitative results show a strong linear relationship as per the Deming Regression equation above. |

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

• Sample Size: 128 samples
• Data Provenance: Not specified (e.g., country of origin, participant demographics). It is a retrospective dataset used for comparison.

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

Not applicable. This is an immunoassay measuring a biomarker, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for this study is essentially the measurement from the established predicate device (Bayer Immuno-1 CA 15-3).

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for comparing quantitative biomarker measurements between two devices. The comparison is direct by measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This device is an automated immunoassay, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this study represents a standalone performance evaluation. The ADVIA Centaur CA 15-3 assay is an automated immunoassay system, meaning it functions without human involvement in the measurement process, producing quantitative results directly. The study evaluates its performance (specifically, its correlation to a predicate device) in this standalone capacity.

7. The Type of Ground Truth Used

The ground truth or reference standard for this study was the measurements obtained from the legally marketed predicate device, the Bayer Immuno-1 CA 15-3 assay. The goal was to show substantial equivalence, meaning the new device's measurements correlate strongly with the predicate's measurements.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance evaluation of a medical device (immunoassay kit), not a machine learning model that undergoes a "training" phase. The assay is based on chemical reactions and antibodies, not AI algorithms.

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

Not applicable, as no training set for a machine learning model is involved.

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