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510(k) Data Aggregation
(487 days)
VIDAS® CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 is indicated for the serial measurement of CA 15-3 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with breast cancer for disease progression or response to therapy in conjunction with other clinical methods. The VIDAS CA 15-3 assay can also be used as an aid in the detection of recurrence in previously treated Stage II and III breast cancer patients.
VIDAS CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 levels in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 assay is indicated for the serial measurement of CA 15-3 as an aid in the monitoring of disease progression or response to therapy in patients previously diagnosed with breast cancer.
The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with mouse monoclonal 115D8 antibodies. The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the monoclonal 115D8 antibody fixed onto the interior wall of the SPR to capture the reactive antigenic determinants present in the sample. Unbound components are eliminated during the washing steps. Alkaline phosphatase labeled monoclonal DF3 antibody (conjugate) is then incubated in the SPR where it binds with the CA 15-3 reactive antigenic determinant. Unbound conjugate is then eliminated during the washing steps.
During the final detection step, the substrate (4-Methyl-umbellifery| phosphate) is cycled in and out of the SPR. The conjuqate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methy)-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of CA 15-3 reactive antigenic determinants present in the sample.
At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
Here's a summary of the acceptance criteria and study details for the VIDAS® CA 15-3 Assay, based on the provided text:
Acceptance Criteria and Device Performance for VIDAS® CA 15-3 Assay
The device acceptance was based on demonstrating substantial equivalence to a predicate device (TOSOH ST AIA-PACK BRCA) through performance data, including analytical and clinical comparisons. The summary does not explicitly state acceptance criteria in terms of target values for slope or intercept; rather, it presents the results of the comparison to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied by Predicate Performance) | Reported VIDAS® CA 15-3 Assay Performance |
|---|---|---|
| Intra-Assay Precision | CV comparable to predicate (2.2% - 1.4%) | Pool A: 2.1 - 4.0% CV (Mean 270.0 U/mL) |
| Pool B: 3.2 - 4.5% CV (Mean 67.7 U/mL) | ||
| Pool C: 2.3 - 4.1% CV (Mean 21.4 U/mL) | ||
| Inter-Run Precision | CV comparable to predicate (2.2%) | Pool A: 0.0 - 1.2% CV (Mean 270.0 U/mL) |
| Pool B: 0.0 - 1.4% CV (Mean 67.7 U/mL) | ||
| Pool C: 0.6 - 2.2% CV (Mean 21.4 U/mL) | ||
| Limits of Detection | Comparable to predicate (2.0 U/mL) | 0.724 U/mL (< 2.0 U/mL) |
| Method Comparison | Strong correlation with predicate | Slope = 0.96 (95% CI: 0.83 to 1.09) |
| Intercept = -1.94 (95% CI: -4.90 to +1.01) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- Analytical Precision: 40 replicates (for intra-assay), number of replicates not specified for inter-run but based on 20 runs.
- Clinical Method Comparison: 1,035 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective or designed for the specific purpose of this submission, as they involve testing the VIDAS® CA 15-3 Assay against the predicate and established pools.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not describe the use of experts to establish a "ground truth" for the test set in the conventional sense (e.g., for image interpretation). Instead, the performance studies compare the device's measurements against established methods (predicate device measurements) and known concentrations of CA 15-3 in control pools.
4. Adjudication Method for the Test Set:
Not applicable. The study involves quantitative measurements and comparisons to a predicate device and known control values, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging or interpretation where multiple human readers assess cases. The VIDAS® CA 15-3 Assay is an automated quantitative laboratory test.
6. Standalone Performance Study:
Yes, a standalone performance study was done for the VIDAS® CA 15-3 Assay, as evidenced by the "Non-clinical (Analytical) Comparison" which includes intra-assay and inter-run precision, and limits of detection. These metrics assess the performance of the device itself.
7. Type of Ground Truth Used:
- Analytical Performance: The ground truth for analytical precision used known concentrations or pre-established values in "Pools" and "Controls" (e.g., Mean = 270.0 U/mL for Pool A).
- Clinical Method Comparison: The "ground truth" for the method comparison was the measurements obtained from the predicate device, TOSOH ST AIA-PACK BRCA, with which the VIDAS® CA 15-3 Assay was directly compared using a large number of patient samples.
8. Sample Size for the Training Set:
The document does not explicitly mention a "training set" in the context of an algorithm or machine learning model. For this type of in vitro diagnostic device, "training" typically refers to the development and optimization of the assay itself, including reagent formulation, instrument parameters, and potentially curve fitting, which uses internal data during the development phase. The provided summary focuses on validation data.
9. How the Ground Truth for the Training Set Was Established:
As there's no explicit "training set" described for an algorithm, the concept of establishing ground truth for it is not directly applicable in the provided information. For the assay's development (which could be considered analogous to training if it were a machine learning model), the "Master curve for each kit lot and each calibrator lot are traceable to working standards established by bioMérieux, Inc. and value assigned by the Fujirebio Diagnostics, Inc. radioimmunoassay method." This indicates that standardization and traceability to established reference methods were used to define the assay's operational parameters and calibration.
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