(82 days)
The ARCHITECT CA 15-3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used as an aid in the management of Stage II and Stage III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer.
The ARCHITECT CA 15-3 assay is a two-step immunoassay to determine the presence of DF3 reactive determinants in human serum or plasma, using Chemiluminescent Microparticle Immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex™. In the first step, sample, wash buffer and 115D8 coated paramagnetic microparticles are combined. DF3 reactive determinants present in the sample bind to the 115D8 coated microparticles. After washing, DF3 acridinium-labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of DF3 reactive determinants in the sample and the RLUs detected by the ARCHITECT i optical system.
Acceptance Criteria and Device Performance Study for ARCHITECT® CA 15-3® Assay
This document summarizes the acceptance criteria and the study performed to demonstrate that the ARCHITECT® CA 15-3® Assay meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance characteristics, which serve as the acceptance criteria for the device. The reported performance for the ARCHITECT CA 15-3 Assay is compared against these criteria.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reproducibility | Total precision %CV ≤ 8% | The total precision %CV of the ARCHITECT® CA 125 II™ assay was determined to be less than or equal to 8%. (Note: The document mentions "CA 125 II™ assay" here, but the 510(k) is for CA 15-3, implying this criterion is general for ARCHITECT assays or a typo. Assuming it applies to CA 15-3.) |
| Method Comparison | High correlation with predicate device (AxSYM CA 15-3 assay) | Passing-Bablok linear regression analysis comparing the ARCHITECT CA 15-3 assay to the AxSYM CA 15-3 assay yielded a correlation coefficient of 0.980, a slope of 0.94 (99% CI: 0.92, 0.97), and Y-axis intercept of -0.3 U/mL (99% CI: -0.9, 0.0). |
| Reference Ranges | Establishment of normal ranges in apparently healthy populations. | In 396 normal individual specimens, 99.0% of healthy female subjects had CA 15-3 assay values at or below 31.3 U/mL (mean = 13.0, SD = 7.0). Similar distributions were provided for pre-menopausal females (99% |
§ 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.