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510(k) Data Aggregation

    K Number
    K974816
    Device Name
    ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1998-02-20

    (59 days)

    Product Code
    LTJ
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of PSA in human serum.

    AI/ML Overview

    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 CategoryReported Device Performance (ACCESS® PSA Assay)
    Correlationr = 0.994 (vs. Tandem®-R PSA assay)
    y = 1.01x - 0.96 (regression equation vs. Tandem®-R PSA assay)
    Expected Range**97.5%
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