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510(k) Data Aggregation

    K Number
    K963541
    Device Name
    SIGMA DIAGNOSTICS CO2 ACID REAGENT
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-10-24

    (50 days)

    Product Code
    JFL
    Regulation Number
    862.1160
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K963541
    Why did this record match?
    Device Name :

    SIGMA DIAGNOSTICS CO2 ACID REAGENT

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

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

    Device Description

    CO2 Acid Reagent, Procedure Number C7558

    AI/ML Overview

    This document is a 510(k) Notification for a diagnostic medical device, specifically the Sigma Diagnostics CX®3 CO2 Acid Reagent. It is not based on AI/ML; it's a traditional chemical reagent for measuring carbon dioxide. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable to this type of device and study.

    However, I can extract the information relevant to its performance and acceptance criteria based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial equivalency to predicate deviceCorrelation coefficient: 0.992
    Regression equation: y = 0.95x + 1.54
    Within-run precision (Implied %CV target)%CV
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