(132 days)
This in vitro immunoassay is intended to quantitavely measure CA 15-3 values in human serum. When used in conjunction with other clinical and diagnostics procedures, serial testing using ADVIA IMS CA 15-3 Assay on a Bayer ADVIA® IMS ™, is indicated for monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients.
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The information provided describes the performance of the CA 15-3 Assay for the Bayer ADVIA® Integrated Modular System (IMS)™ as part of a 510(k) premarket notification. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes.
Here's an analysis of the provided information, structured according to your request:
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state "acceptance criteria" for each performance metric as a numerical threshold, but rather presents the device's performance characteristics with the implicit understanding that these values are considered acceptable for substantial equivalence to the predicate device. The conclusion explicitly states: "Performance of the ADVIA IMS CA 15-3 Assay on a a Bayer ADVIA® IMS ™ is equivalent to the performance of the CA 15-3 Assay on the predicate device (Immuno 1) and is within proposed specifications."
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate & Equivalence) | Reported Device Performance (ADVIA IMS CA 15-3 Assay) |
|---|---|---|
| Imprecision | Comparable to predicate device (Immuno 1) | Level 1 (12.3 U/mL): 4.7% Total CV |
| Level 2 (29.6 U/mL): 5.5% Total CV | ||
| Level 3 (59.1 U/mL): 5.3% Total CV | ||
| Correlation (vs. Predicate Immuno 1) | Strong linear correlation with predicate device (e.g., R-value close to 1, Syx indicating low scatter) | N = 73 serum specimens |
| Regression Equation: $1.061 * X + 1.50$ (Y=ADVIA IMS, X=Immuno 1) | ||
| Syx (U/mL): 3.04 | ||
| R (Correlation Coefficient): 0.996 | ||
| Sample Range: 7.02 - 184.9 U/mL | ||
| Interfering Substances (Effect % change) | Minimal effect (generally |
§ 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.