(110 days)
The Chiron Diagnostics ACS:Centaur CEA Immunoassay is for the quantitative determination of carcinoembryonic antigen in serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence Systems.
The Chiron Diagnostics ACS:Centaur CEA immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-CEA antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-CEA antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of CEA present in the patient sample and the amount of relative light units (RLU's) detected by the system.
Here's a breakdown of the acceptance criteria and study information for the ACS:Centaur CEA Immunoassay, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity | Minimum detectable concentration: 0.5 ng/mL |
| Accuracy (Correlation to predicate device) | ACS:Centaur CEA = 0.97 (ACS:180 CEA) = 0.04 ng/mL, |
| Correlation coefficient (r) = 0.99 (for 284 samples in the range of 0.5 to 78.5 ng/mL) |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 284 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the context of a new device being compared to a legally marketed predicate suggests these were clinical samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given document. The "ground truth" for accuracy in this context is the measurement by the predicate device (ACS:180 CEA), not expert interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as the evaluation is a direct comparison of quantitative measurements from two immunoassay devices, not expert adjudication of clinical findings.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not a MRMC study. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-powered image analysis or clinical decision support tool designed to assist human readers. Therefore, the concept of human reader improvement with/without AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance evaluation of the ACS:Centaur CEA immunoassay device itself. It measures CEA concentration directly from serum samples without human interpretation of raw data in the same way an AI algorithm would operate. Its performance is compared to another device (the predicate), not human performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for accuracy in this study was the quantitative measurement obtained from the predicate device, the ACS:180 CEA Immunoassay. The study sought to demonstrate substantial equivalence to an already legally marketed device.
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The sample size for the training set:
- This information is not provided in the document. For an immunoassay device, the "training set" might refer to data used during the development and calibration of the assay, but specific details about this are not included in the 510(k) summary.
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How the ground truth for the training set was established:
- This information is not provided in the document. Similar to the training set size, the specifics of how internal calibration standards or reference materials were established during the assay development are beyond the scope of this 510(k) summary.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.