(13 days)
The Access CEA assay is a paramagnetic particle, chemiluminescent immunossay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay System. CEA measured by the Access Immunoassay System is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
The Access® CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate, and wash buffer.
- . The Access® CEA reagent packs consist of paramagnetic particles coated with monoclonal (mouse) anti-human CEA antibodies in Tris buffered saline, sample diluent, monoclonal anti-human CEA-alkaline phosphatase conjugate in phosphate buffered saline, bovine serum albumin (BSA) and preservatives.
- . The Access® CEA calibrators consist of multi-point calibrators for use with the Access CEA assay. The calibrator vials contain zero and approximately 1, 10, 100, 500, and 1000 ng/ml purified CEA, respectively, in a phosphate buffered BSA matrix with preservatives.
- . The Access® CEA QC controls consist of approximately 3 ng/ml and 300 ng/ml of human CEA in a phosphate buffered BSA matrix with preservatives.
- . The Access® substrate, Lumi-Phos* 530, is a dioxetane-based chemiluminescent substrate.
- . The Access® wash buffer consists of Tris buffered saline containing surfactant and preservatives.
The provided text describes the Access® CEA Assay, a two-site immunoenzymatic "sandwich" assay, and its modification for improved correlation around a critical decision point of 5.0 ng/ml. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical validation reports.
The provided text focuses on the device description, principles of the procedure, indications for use, and a modification to the calibrator mass to improve correlation with an existing device. It also includes an FDA 510(k) clearance letter.
Therefore, many of the requested details cannot be extracted from the given information.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of reported device performance metrics against such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document states that "Insert changes have been made to reflect results from completed validation studies," but it does not detail these validation studies, including sample size, data provenance, or study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This device is an in-vitro diagnostic (IVD) immunoassay measuring a biomarker (CEA). Ground truth for such devices is typically established through reference methods or clinical outcomes, not expert consensus on images or interpretations. The document does not describe how ground truth was established for any validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided. Adjudication methods are typically used in studies involving human interpretation (e.g., imaging studies) where expert consensus resolves discrepancies. This is an immunoassay, not an interpretation-based device. No information on any "test set" and its adjudication is available.
5. 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
- Not applicable. This is an automated immunoassay device, not an AI-assisted diagnostic tool requiring human readers. Therefore, an MRMC study and effects on human reader performance are not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. As an automated immunoassay, the device performs "standalone" by producing a quantitative result. The study of its performance (which is alluded to as "validation studies" but not detailed) would inherently be a standalone study of the algorithm/assay's ability to measure CEA.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicitly, reference methods or clinical diagnosis related to cancer management. For an immunoassay like CEA, ground truth would typically be established by using a reference method for CEA measurement, or by correlating CEA levels with clinical diagnosis, disease progression, or treatment response in cancer patients, as it's used as "an aid in the management of cancer patients." However, the specific method is not detailed in the provided text.
8. The sample size for the training set
- Cannot be provided. This document describes a modification to an existing device (re-calibration) and refers to "validation studies" for this modification. It does not mention a "training set" in the context of device development or machine learning, which is not applicable to a traditional immunoassay.
9. How the ground truth for the training set was established
- Cannot be provided. As a training set is not mentioned and is not typically relevant for this type of device, this question cannot be answered.
Summary based on available information:
| Information Type | Details |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Cannot be provided. Document does not specify quantitative acceptance criteria or present performance data against them. It only mentions calibration improvement around 5.0 ng/ml for better correlation with another device. |
| 2. Test Set Sample Size & Data Provenance | Cannot be provided. "Validation studies" are mentioned, but their details (sample size, retrospective/prospective, country of origin) are absent. |
| 3. Number & Qualifications of Experts for Ground Truth (Test Set) | Not applicable. This is an immunoassay, not an interpretation-based device. Ground truth is typically clinical or by reference methods, not expert consensus on interpretations. |
| 4. Adjudication Method (Test Set) | Not applicable. No details provided, as adjudication is typically for subjective interpretations, not automated quantitative measurements from an immunoassay. |
| 5. MRMC Comparative Effectiveness Study (AI vs. without AI) | Not applicable. This is an automated immunoassay, not an AI-assisted diagnostic tool involving human readers. |
| 6. Standalone Performance Study (Algorithm Only) | Implicitly Yes. As an automated immunoassay, any performance study would inherently be a standalone evaluation of the device's measurement capabilities. The document alludes to "validation studies." |
| 7. Type of Ground Truth Used | Implicitly by reference methods or clinical outcomes. For CEA, ground truth is typically established by comparing results to reference CEA assays or correlating with patient clinical status, disease progression, or treatment response consistent with its "aid in the management of cancer patients" indication. Specifics are not provided. |
| 8. Training Set Sample Size | Cannot be provided. No mention of a "training set" as this is a traditional immunoassay, not a machine learning model. The modification involved re-calibration based on existing data, not training an AI model. |
| 9. Ground Truth Establishment for Training Set | Cannot be provided. As a training set is not described, the method for establishing its ground truth is also not mentioned. The re-calibration was explicitly to "improve correlation with another commercially available device," suggesting cross-validation against an established product rather than creation of a de novo training set with new ground truth. |
§ 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.