(203 days)
The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined. AFP testing is not recommended as a screening procedure to detect cancer in the general population.
The Bayer ADVIA® IMS™ AFP assay is an in vitro diagnostic device intended to quantitatively measure afetoprotein (AFP) in human serum on the Bayer ADVIA IMS system.
Acceptance Criteria and Study for Bayer ADVIA® IMS™ AFP Assay
This document summarizes the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the Bayer ADVIA® IMS™ AFP Assay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ADVIA IMS AFP Assay are primarily established by demonstrating substantial equivalence to the predicate device, Immuno 1 AFP Assay, across various performance metrics. The specific quantitative acceptance criteria are implicitly defined by the reported performance metrics of the predicate device and the observed performance of the new device.
| Performance Metric | Acceptance Criteria (Implicit, based on predicate performance) | Reported Device Performance (ADVIA IMS AFP Assay) |
|---|---|---|
| Imprecision (Total CV%) | Comparable to Immuno 1 | Level 4.6 ng/mL: 2.3% |
| Level 18.97 ng/mL: 2.7% | ||
| Level 93.52 ng/mL: 2.6% | ||
| Correlation: Regression Equation (Y=ADVIA IMS, X=Immuno 1) | Close to Y=X (slope ~1, intercept ~0) | Y = 1.06 * X - 3.18 |
| Correlation: Syx | Low Syx, indicating good agreement | 5.82 ng/mL |
| Correlation: R (correlation coefficient) | High (close to 1) | 0.998 |
| Interfering Substances (Effect % change) | Effect within acceptable limits (typically |
§ 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.