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510(k) Data Aggregation

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

    (120 days)

    Product Code
    LTJ
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    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
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