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510(k) Data Aggregation

    K Number
    K012878
    Device Name
    THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
    Manufacturer
    THERMO DMA, INC.
    Date Cleared
    2001-10-16

    (49 days)

    Product Code
    JIS,CAL
    Regulation Number
    862.1150
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K974620
    Why did this record match?
    Reference Devices :

    K974620

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

    This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.

    Device Description

    The Thermo Trace Ammonia Standards are aqueous (ammonia free deionized water) solutions of Ammonium Sulfate (Merck GR ACS (ammonia rece delonioa navis) preservative (Sodium Azide). The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent (K974620) to establish points of reference that are used in the determination of Ammonia in human plasma.

    AI/ML Overview

    This document describes the Thermo Trace Ammonia Standards Set, which is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent to establish points of reference for the determination of Ammonia in human plasma.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text describes the process for establishing and validating the values of the Thermo Trace Ammonia Standards Set rather than presenting explicit acceptance criteria with numerical performance targets and reported device performance against those targets. Instead, the "acceptance criteria" are implied by the methods used to ensure the quality and accuracy of the standards.

    Acceptance Criteria (Implied)Reported Device Performance/Method of Verification
    Purity/CompositionSpecified amount of Anhydrous Ammonium Sulfate accurately weighed on a calibrated analytical balance and dissolved in Class A volumetric flask with ammonia-free deionized water (
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