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510(k) Data Aggregation

    K Number
    K011665
    Device Name
    BCT SYSTEM
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2001-08-09

    (71 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K964139,K955278,K001064,K001067
    Why did this record match?
    Device Name :

    BCT SYSTEM

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

    The BCT™ System is an automated coaqulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters:

    • Activated Partial Thromboplastin Time (APTT)
    • Antithrombin IIIa
    • Batroxobin
    • D-dimer
    • Deficient Plasmas
    • Derived Fibrinogen
    • Fibrinogen
    • Heparin
    • Lupus Anticoagulants
    • Prothrombin Time (PT)
    • Plasminogen
    • Protein C-clotting
    • Protein C-chromogenic
    • Thrombin Time
    • von Willebrand factor
    Device Description

    The current BCT™ System was originally determined to be substantially equivalent as a coagulation analyzer in 510(k) Premarket Notification K955278. Subsequent to its clearance, the indications for use of the instrument were expanded through two additional Premarket Notifications, K001064 and K001067 for the addition of various analytes. The current BCT™ System was cleared to perform coagulometric, and chromogenic tests, such as the routine tests: prothrombin time, partial thromboplastin time, heparin, and fibrinogen, as well as the special tests: single factor determination, antithrombin IIIa, batroxobin, plasminogen, protein C, and D-dimer. The inclusion of the new testing parameter, lupus anticoagulants (LA), is the subject of this modification. The addition of the new proposed analyte to the instrument was accomplished without modification to the instrument principle, operation, hardware or instruction manual.

    AI/ML Overview

    This document describes the modification of the Dade Behring BCT™ System to include the new testing parameter, lupus anticoagulants (LA). The study demonstrates that the modified BCT™ system is substantially equivalent to the Sysmex® CA-6000 System for measuring Lupus Anticoagulants.

    1. Table of Acceptance Criteria and Reported Device Performance:

    The acceptance criteria for this 510(k) modification are based on demonstrating substantial equivalence to a predicate device (Sysmex® CA-6000 System) through correlation and precision studies. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient) are not stated, the reported performance data is presented to show strong correlation, suggesting the device meets internal benchmarks for equivalence.

    Correlation Study (Method Comparison):

    AssayAcceptance Criteria (Implied: Strong Correlation to Predicate)Reported Performance (Coefficient of Correlation (r))Regression Equation
    LA 1 Screening Reagent (seconds)R-value close to 1.00.968y=0.87x + 4.34
    LA 2 Confirmation Reagent (seconds)R-value close to 1.00.882y=0.76x + 5.46
    LA 1/LA 2 RatioR-value close to 1.00.965y=1.08x + 0.05
    LA 1 Screening Reagent (normalized)R-value close to 1.00.969y=0.89x + 0.11
    LA 2 Confirmation Reagent (normalized)R-value close to 1.00.882y=0.84x + 0.15
    LA 1/LA 2 Ratio (normalized)R-value close to 1.00.964y=0.97x + 0.04

    Precision Study (Implied Acceptance Criteria for %CV based on typical industry standards for coagulation assays):

    AssaySampleAcceptance Criteria (Implied: Low %CV)Reported Performance (Total %CV)
    LA 1 Screening Reagent (seconds)LA Control HighTypically
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