(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 ( |
§ 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.