LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974842
    Device Name
    IMMULITE 2000 3RD GENERATION PSA
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    1998-04-21

    (118 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 DPC IMMULITE 2000 3rd Gen. PSA kit is intended for the quantitative measurement of prostate specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device called "IMMULITE 2000 3rd Gen. PSA," which is a kit for the quantitative measurement of prostate specific antigen (PSA). This type of document does not contain the acceptance criteria, study details, or performance data requested in your prompt.

    FDA 510(k) clearance letters primarily state that the device has been found substantially equivalent to a legally marketed predicate device. They do not typically include detailed reports of clinical studies, performance metrics, or ground truth establishment. These details would be found in the manufacturer's 510(k) submission, which is not provided here.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth methods based solely on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1