K Number
K994221
Device Name
BAYER PSA ASSAY
Manufacturer
Date Cleared
2000-04-13

(120 days)

Product Code
Regulation Number
866.6010
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

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

AI/ML Overview

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 MetricAcceptance Criteria (Implied/Reference)Reported Device Performance (ACS: 180)Reported Device Performance (ADVIA Centaur)
Analytical SensitivityNot explicitly stated but expected to be precise at low concentrations0.06 ng/mL (minimum detectable concentration) at 2 SD above mean zero standard0.06 ng/mL (minimum detectable concentration) at 2 SD above mean zero standard
Assay RangeNot explicitly stated (standard for PSA assays)Up to 100 ng/mLUp 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/AADVIA 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 levelsNot 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.