(111 days)
The Access® CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic antigen (CEA) in human serum using the ACCESS Immunoassay System. CEA measured by the Access CEA Immunoassay, is used as an aid in the management of cancer patients.
The ACCESS CEA Immunoassay Reagents and the ACCESS Immunoassay Analyzer comprise the ACCESS Immunoassay System for the quantitative determination of CEA in human serum.
The provided text describes a 510(k) submission for the ACCESS® CEA Assay, a device intended for the quantitative determination of carcinoembryonic antigen (CEA) in human serum to aid in the management of cancer patients. The submission focuses on demonstrating substantial equivalence to a predicate device, the Abbott IMx CEA Microparticle Enzyme Immunoassay.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the ACCESS CEA Immunoassay in numerical thresholds. Instead, it presents summaries of studies demonstrating its performance in comparison to the predicate device and in various analytical tests. The underlying acceptance logic for substantial equivalence would be that the performance of the new device is comparable to or better than the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Comparison/Analytical Limits) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Device (Abbott IMx CEA) | Strong correlation (e.g., r > 0.95 and slope ~1, intercept ~0) | 146 samples (0-1000 ng/ml). r = 0.97; y = 1.02x + 1.76. |
| Expected Range (Healthy Population) | Low CEA values for apparently healthy individuals. | 98.7% of 234 healthy individuals had CEA ≤ 5.0 ng/ml; 1.3% had 5.1-10.0 ng/ml. |
| Monitoring Data (Longitudinal Samples) | High concordance with predicate device and clinical assessments for monitoring cancer patients. | ACCESS CEA results were "highly concordant to both the IMx CEA results and the concurrent clinical assessments." |
| Recovery (Linearity) | Average recovery close to 100%, within an acceptable range (e.g., 90-110%). | Average recovery of 99.9% (range 91.1-109.1%) for diluted samples. Average recovery of 103.0% (range 99.0-106.2%) for spiked samples. |
| Precision (Imprecision) | Imprecision (CV) generally low, usually |
§ 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.