LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130020
    Device Name
    ACCESS TOTAL BHCG (5TH IS)
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2013-10-01

    (271 days)

    Product Code
    DHA,JIX
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k925277
    Why did this record match?
    Device Name :

    ACCESS TOTAL BHCG (5TH IS)

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

    The Access Total (BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. The assay is intended for use as an aid in the early detection of pregnancy.

    The Access Total BhCG (5th IS) calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.

    Device Description

    The Access Total βhCG (5" IS) assay (standardized to WHO 5" International Standard), Access Total BhCG (5th IS) calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of total βhCG in human serum and plasma.

    AI/ML Overview

    The provided text describes the performance of the Beckman Coulter Access Total βhCG (5th IS) Assay and Calibrators. The primary "acceptance criteria" for this device, as presented in the 510(k) summary, are derived from various analytical performance studies, which aim to demonstrate substantial equivalence to a predicate device.

    Here's an analysis based on your requested information:

    1. A table of acceptance criteria and the reported device performance

    The document doesn't explicitly state "acceptance criteria" as a separate compiled list. Instead, performance characteristics are presented as results from various studies. I will infer the acceptance criteria from the reported results and the context of device validation for regulatory submission (e.g., meeting established thresholds for imprecision, linearity, etc.).

    Acceptance Criteria (Inferred)Reported Device Performance
    Method Comparison (vs. Predicate):
    Slope of Passing-Bablok regression: Approximately 1.00 (CI around 1.00)Slope = 1.04 (95% CI: 1.02 to 1.06)
    Intercept of Passing-Bablok regression: Approximately 0 mIU/mLIntercept = 2.87 mIU/mL
    Pearson correlation (r): Close to 1.00r = 0.99
    Imprecision (CV% or SD):
    Total imprecision for concentrations > 3.9 mIU/mL:
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1