(258 days)
VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.
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 anti-CEA monoclonal immunoglobulins (mouse). The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).
After dilution, the sample is transferred into the well containing CEA antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during the first washing step.
A second incubation step is then performed with alkaline phosphatase-labeled anti-CEA polyclonal antibodies (goat). The unbound conjugate is then eliminated during washing steps.
During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen 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.
The provided document describes the VIDAS® CEA (S) Assay, a medical device for measuring Carcinoembryonic antigen (CEA) in human serum, and compares its performance to a predicate device, the TOSOH ST AIA-PACK CEA. This is an In Vitro Diagnostic (IVD) device, not an AI or imaging device, so many of the requested fields (like number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set information) are not applicable or typically reported for this type of device.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For IVD devices like the VIDAS® CEA (S) Assay, acceptance criteria are typically demonstrated through analytical and clinical performance studies that show equivalence to a legally marketed predicate device. The document uses the TOSOH ST AIA-PACK CEA as its predicate. The key performance metrics are analytical precision (intra-assay and inter-run) and method comparison (correlation with the predicate device).
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Equivalence) | Reported VIDAS® CEA (S) Assay Performance |
|---|---|---|
| Intra-Assay Precision (CV) | Predicate: |
§ 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.