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510(k) Data Aggregation

    K Number
    K963538
    Device Name
    SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-10-11

    (37 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIGMA DIAGNOSTICS CO2ALKALINE BUFFER

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

    to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX 3 System

    Device Description

    CO2 Alkaline Buffer, Procedure Number C7683

    AI/ML Overview

    Here is an analysis of the provided text based on your request, focusing on the acceptance criteria and study details for the Sigma Diagnostics CO2 Alkaline Buffer:

    This 510(k) premarket notification describes a new device (Sigma Diagnostics CO2 Alkaline Buffer) and demonstrates its substantial equivalence to a predicate device (Beckman CO2 Alkaline Buffer Kit). The study's primary goal is to show that the new device performs as safely and effectively as the existing one.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance (Sigma Diagnostics CO2 Alkaline Buffer)
    Substantial EquivalenceDemonstrated substantial equivalency to Beckman CO2 Alkaline Buffer KitAchieved
    CorrelationCorrelation coefficient with predicate device0.992
    Regression EquationRegression equation with predicate devicey = 0.95x + 1.54
    Within-run Precision (%CV)%CV
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