(379 days)
The CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparinized plasma on the Dimension Vista System. Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.
Dimension Vista® CEA Flex® reagent cartridge: The CEA method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CEA monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-CEA monoclonal antibody and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CEA-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Ulumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the CEA concentration in the sample.
Dimension Vista® LOCI 5 Calibrator: LOCI 5 CAL is a liquid, multi-analyte, bovine serum albumin based product containing CEA from human tissue culture.
Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® CEA Flex® reagent cartridge and Dimension Vista® LOCI 5 Calibrator, based on the provided text:
Acceptance Criteria and Device Performance
The study demonstrates substantial equivalence to the predicate device, Beckman Access® CEA Reagents on the Access® Immunoassay System. The acceptance criteria are implicitly defined by showing comparable performance characteristics, particularly in method comparison (correlation) and precision.
| Characteristic | Acceptance Criteria (Implicit, based on predicate) | Reported Device Performance (Dimension Vista® CEA Flex® reagent cartridge) |
|---|---|---|
| Method Comparison | Strong correlation with predicate device (e.g., correlation coefficient close to 1) | Correlation Coefficient: 0.989 (for 0.8-974 ng/mL range), 0.970 (for 0.8-17.1 ng/mL range) |
| Slope: 1.01 (first study), 1.04 (second study) | ||
| Intercept: 9.01 ng/mL (first study), 0.44 ng/mL (second study) | ||
| Precision | Comparable to predicate device: |
- Within Run: 3.01 – 3.97 %CV
- Total: 3.80 - 4.51 %CV | Repeatability: 1.3 - 2.9 %CV
Within-Lab: 2.1 - 3.6 %CV |
| Measuring Range | 0.1 - 1000.0 ng/mL | 0.2 - 1000.0 ng/mL |
Study Details
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Sample size used for the test set and the data provenance:
- Method Comparison:
- 141 values for correlation study, range 0.8 - 974 ng/mL [µg/L].
- 46 values for correlation study, range 0.8 - 17.1 ng/mL [ug/L].
- Precision:
- Multiple test materials (Liquichek™ Immunoassay Plus Control Levels 1 & 2, Serum pools 1-5, Plasma pool) were analyzed. Specific sample numbers for each material are not explicitly stated, but the testing involved "two separate runs, with two test samples, for each test material, were analyzed for 20 days."
- Data Provenance: Not explicitly stated, but clinical laboratory studies are typically prospective. No country of origin is specified.
- Method Comparison:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic device for quantitative measurement, and "ground truth" is established by the reference method (predicate device) and analytical precision. No human expert interpretation of results is part of this type of study for device performance.
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Adjudication method for the test set: Not applicable. This is an analytical performance study, not a study involving human interpretation or adjudication.
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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: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is a standalone analytical performance study of the Dimension Vista® CEA Flex® reagent cartridge on the Dimension Vista® System. The performance metrics (correlation, precision) are for the assay system itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for method comparison was established by the predicate device (Beckman Access® CEA Reagents on the Access® Immunoassay System). For precision, standard reference materials and pooled samples were used as typical in analytical chemistry.
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that uses a "training set" in the conventional sense. The device is a chemical reagent and instrument system.
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How the ground truth for the training set was established: Not applicable. (See #7).
§ 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.