(120 days)
The Bayer Diagnostics PSA Immunoassay is for the quantitative serial determination of prostate specific antigen in human serum and to aid in the managenent (monitoring) of patients with prostate cancer
The ACS:180 and ADVIA Centaur PSA assays are a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The direct offermilammomotio to a polyclonal anti-goat antibody labeled with acridinium not ankibody, in the Solid Phase, is a monoclonal anti-mouse antibody, which is covalently coupled to paramagnetic particles.
A direct relationship exists between the amount of PSA present in the patient sample and the amount of relative light units (RLUs) detected by the system
Here's an analysis of the provided text, focusing on acceptance criteria and the study data, organized by your requested points:
Bayer Diagnostics ACS: 180/ADVIA Centaur PSA Assay Performance Data
This document describes the performance of the Bayer Diagnostics ACS: 180 and ADVIA Centaur PSA assays, which are immunoassays for the quantitative determination of prostate-specific antigen (PSA) in human serum.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as pass/fail thresholds for specific metrics. However, it presents various performance characteristics intended to demonstrate the device's analytical capabilities and equivalence to a predicate device. For this table, I will present the reported performance data for key metrics.
Performance Metric | Acceptance Criteria (Implied/Reference) | Reported Device Performance (ACS: 180) | Reported Device Performance (ADVIA Centaur) |
---|---|---|---|
Analytical Sensitivity | Not explicitly stated but expected to be precise at low concentrations | 0.06 ng/mL (minimum detectable concentration) at 2 SD above mean zero standard | 0.06 ng/mL (minimum detectable concentration) at 2 SD above mean zero standard |
Assay Range | Not explicitly stated (standard for PSA assays) | Up to 100 ng/mL | Up to 100 ng/mL |
Accuracy (Method Comparison with Alternate Method) | Strong correlation (e.g., r > 0.95, slope ~1, intercept ~0) | ACS: 180 PSA = 0.98 (alternate method) + 0.0118 ng/mL; r = 0.986 (for 629 samples, 0.06-100 ng/mL) | Not directly compared to "alternate method" in this section |
Accuracy (Method Comparison with ACS: 180) | Strong correlation (e.g., r > 0.95, slope ~1, intercept ~0) | N/A | ADVIA Centaur PSA = 0.99 (ACS: 180 PSA) - 0.09 ng/mL; r = 0.990 (for 661 samples, 0.06-100 ng/mL) |
Precision (Total % CV) at specific PSA levels | Not explicitly stated (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.