(63 days)
The ARCHITECT CEA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma on the ARCHITECT i System. The ARCHITECT CEA assay is to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
ARCHITECT CEA is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of CEA in human serum and plasma. ARCHITECT CEA is calibrated with ARCHITECT CEA Calibrators. ARCHITECT CEA Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
Here's an analysis of the provided text regarding the Abbott ARCHITECT™ CEA, focusing on acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Abbott ARCHITECT™ CEA assay are implicitly defined by its performance comparison to a legally marketed predicate device, the Abbott AxSYM® CEA assay. The study aims to demonstrate substantial equivalence, meaning its performance is comparable to the predicate.
| Performance Metric | Acceptance Criteria (Predicate Performance) | Reported Device Performance (ARCHITECT CEA vs. AxSYM CEA) |
|---|---|---|
| Correlation Coefficient | High correlation (not explicitly stated, but implied by typical IVD equivalence studies which aim for >0.95 or >0.97) | 0.991 (least squares and Passing-Bablok) |
| Slope (Least Squares) | Near 1.0 (indicating proportional agreement) | 0.92 (95% CI: 0.91 to 0.93) |
| Y-intercept (Least Squares) | Near 0.0 (indicating no constant bias) | 0.85 ng/mL (95% CI: 0.01 to 1.69) |
| Slope (Passing-Bablok) | Near 1.0 | 0.97 (95% CI: 0.96 to 0.98) |
| Y-intercept (Passing-Bablok) | Near 0.0 | 0.28 ng/mL (95% CI: 0.26 to 0.30) |
| Distribution of CEA concentrations across various conditions | Similar to predicate | Similar distribution (qualitative statement) |
| Trending in monitoring cancer patients | Similar to predicate | Similar trending (qualitative statement) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 1,069 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it uses banked specimens to compare the two assays. Prospective data collection is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable / not provided. This study is a method comparison study between two diagnostic assays, not a study evaluating human interpretation against a ground truth. Therefore, there's no mention of experts required to establish a diagnostic ground truth for the specimens. The 'ground truth' here is essentially the measurement from the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. As this is a method comparison study between two assays, there's no human interpretation or subjective assessment that would require an adjudication method. The values obtained from each assay are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not a MRMC study. It is a direct comparison of a new automated diagnostic assay (ARCHITECT CEA) against an existing automated diagnostic assay (AxSYM CEA) using patient samples. It does not involve human readers interpreting images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, implicitly. The entire study reflects the standalone performance of the ARCHITECT CEA assay, as it directly measures CEA levels in samples. The comparison is against another automated assay, not against human interpretation. The "algorithm" here refers to the immunoassay technology itself and its automated processing on the ARCHITECT i System.
7. The Type of Ground Truth Used
- Comparison to a Predicate Device. The "ground truth" in this context is the performance of the legally marketed predicate device, the Abbott AxSYM® CEA assay. The study aims to show that the new ARCHITECT CEA assay produces results that are statistically comparable and clinically similar to the established predicate. It is not an absolute ground truth like pathology for a cancer diagnosis, but rather a comparative ground truth for assay performance.
8. Sample Size for the Training Set
- Not explicitly stated/not applicable in this context. The document describes a comparison study, not a machine learning model that requires a distinct "training set" in the conventional sense. The "training" for the ARCHITECT CEA assay would involve internal assay development, optimization, and calibration (which is mentioned as being done with ARCHITECT CEA Calibrators), but the specific sample size for such activities is not provided as part of this substantial equivalence submission. The 1,069 specimens are used for the comparison (test) phase.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As indicated above, a distinct "training set" with established ground truth for a machine learning model is not described in this document. The calibration of the ARCHITECT CEA assay is mentioned: "ARCHITECT CEA is calibrated with ARCHITECT CEA Calibrators." The establishment of these calibrator values would involve a separate, internal process by the manufacturer, typically traceable to reference materials or established methods.
§ 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.