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    K Number
    K962407
    Device Name
    N/T PROTEIN CONTROL PY
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1996-07-29

    (38 days)

    Product Code
    GIL,DBA,DEM,GIT,JJX
    Regulation Number
    864.7340
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    N/T PROTEIN CONTROL PY

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

    N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha -- Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C+ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem.
    *not available in the U.S.

    Device Description

    The N/T Protein Control PY is a lyophilized pool of citrate plasma consisting of one level containing the following proteins:
    fibrinogen antithrombin III prothrombin plasminogen alpha 1 - Antitrypsin C1 Inhibitor

    AI/ML Overview

    Below is an analysis of the provided text regarding acceptance criteria and study details for the "N/T Protein Control PY" device. Please note that the document primarily focuses on demonstrating substantial equivalence and provides limited information typically found in a comprehensive medical device performance study, especially for AI-based devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes a quality control material and focuses on its precision and stability, rather than diagnostic accuracy against a specific condition. Therefore, typical acceptance criteria like sensitivity, specificity, or AUC are not applicable here. The acceptance criteria for this type of device generally revolve around its ability to provide consistent and stable control values.

    Acceptance Criteria CategorySpecific Criteria/MetricTarget (Acceptance Criteria)Reported Device Performance
    Precision%CV (Coefficient of Variation)Not explicitly stated as a target, but lower %CV is better indicating high precision.Ranged from 1.11% to 2.72% for various parameters.
    Stability (Lyophilized)Duration of stabilityNot explicitly stated as a target, but longer stability is better.At least 12 months
    Stability (Reconstituted)Duration of stabilityNot explicitly stated as a target, but longer stability is better.14 days

    Note: The document does not explicitly state numerical "acceptance criteria" for precision or stability (e.g., "%CV must be

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