(45 days)
The Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS 180: Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage III breast cancer. Serial testing for CA 27,29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression of disease in response to treatment.
The Chiron Diagnostics ACS:180 BR assay is a fully automated, competitive, chemiluminescent assay. One reagent, designated Lite Reagent, is composed of a mouse monoclonal antibody specific for CA 27.29, labeled with acridinium ester. The antibody used in the assay, MAb B27.29, binds to a peptide epitope in the tandem repeat region of the MUC-1 gene product. The Solid Phase is composed of purified breast cancer antigen (CA 27.29) which is covalently coupled to paramagnetic particles (PMP). The patient serum sample is incubated with both reagents simultaneously for 7.5 minutes. The ACS: 180 system automatically performs the following steps: dispenses sample into a cuvette, dispenses Lite Reagent and Solid Phase and incubates for 7.5 minutes, separates, aspirates and washes the cuvettes, dispenses reagents which initiate the chemiluminescent reaction, reports results. An inverse relationship exists between the concentration of CA 27.29 in a sample and the relative light units (RLU) detected by the system.
Chiron Diagnostics ACS:180 BR - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state formal "acceptance criteria" in a numerical or target-based format for the clinical performance of the ACS:180 BR. Instead, it presents the assay's performance characteristics and then concludes that these were "substantially equivalent" to the predicate device. Therefore, the "acceptance criteria" can be inferred as achieving substantial equivalence to the predicate device's performance.
| Performance Metric | Inferred Acceptance Criteria (Substantial Equivalence to Predicate Device) | Reported Device Performance (ACS:180 BR) |
|---|---|---|
| For monitoring recurrence (1 Value > ULN): | Similar sensitivity, specificity, PPV, NPV to predicate. | Sensitivity: 60% (39, 79), Specificity: 93% (87, 96), PPV: 60% (39, 79), NPV: 93% (87, 96) |
| For monitoring recurrence (2 Consecutive Values > ULN): | Similar sensitivity, specificity, PPV, NPV to predicate. | Sensitivity: 48% (28, 69), Specificity: 98% (94, 100), PPV: 80% (52, 96), NPV: 91% (85, 95) |
| For managing metastatic disease (Sensitivity to Change): | Similar sensitivity to predicate. | Sensitivity to Change in Disease Status: 73% (58, 85) |
| For managing metastatic disease (Specificity to Change): | Similar specificity to predicate. | Specificity to Change in Disease Status: 71% (53, 85) |
| For managing metastatic disease (PPV to Change): | Similar PPV to predicate. | Positive Predictive Value to Change in Disease Status: 77% (61, 88) |
| For managing metastatic disease (NPV to Change): | Similar NPV to predicate. | Negative Predictive Value to Change in Disease Status: 67% (49, 81) |
| Correlation with Predicate Device (203 specimens): | Strong correlation (e.g., r > 0.90, slope ~ 1, y-intercept ~ 0). | r = 0.96, slope = 1.05, y-intercept = 6 U/mL |
| Correlation with Predicate Device (103 breast cancer specimens): | Strong correlation (e.g., r > 0.90, slope ~ 1, y-intercept ~ 0). | r = 0.96, slope = 1.04, y-intercept = 8 U/mL |
| Analytical Sensitivity |
§ 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.