(59 days)
The Access® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESS Immunoassay System. PSA measured by the Access PSA Immunoassay, is used as an aid in the management of patients with prostate cancer.
The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of PSA in human serum.
The provided document describes a 510(k) submission for the ACCESS® PSA Assay, which is intended for quantitative determination of Prostate-Specific Antigen (PSA) in human serum and for use as an aid in the management of patients with prostate cancer. The acceptance criteria and supporting studies are presented in comparison to a predicate device, the Tandem®-R PSA assay.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative manner for all parameters, but rather demonstrates performance by comparing to a predicate device and presenting observed results. For the purpose of this analysis, the "reported device performance" are the results achieved in the described studies, implying these met the implicit acceptance criteria for substantial equivalence to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (ACCESS® PSA Assay) |
|---|---|
| Correlation | r = 0.994 (vs. Tandem®-R PSA assay) |
| y = 1.01x - 0.96 (regression equation vs. Tandem®-R PSA assay) | |
| Expected Range | **97.5% |
§ 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.