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510(k) Data Aggregation

    K Number
    K991157
    Device Name
    N LATEX STFR REAGENT
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    1999-08-02

    (117 days)

    Product Code
    DDG
    Regulation Number
    866.5880
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K970718
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The N Latex sTfR Reagent is an in vitro diagnostic reagent for the quantitative determination of sTfR in human serum or heparinized plasma using the Behring Nephelometer Systems (BNA, BN100, & BNII), and aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

    Device Description

    N Latex sTfR Reagent is intended to be used together with the Behring Nephelometer Systems for the quantitative determination of soluble transferrin receptor (sTfR) in human serum or heparinized human plasma.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Dade Behring Inc. N Latex sTfR Reagent, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The FDA 510(k) summary for the N Latex sTfR Reagent primarily focuses on establishing substantial equivalence to a predicate device rather than defining new, explicit acceptance criteria in the traditional sense. The performance characteristics described are used to demonstrate that the device performs comparably to the predicate. Therefore, the "acceptance criteria" can be inferred from what the manufacturer chose to report as sufficient for equivalence.

    Performance CharacteristicAcceptance Criteria (Inferred from Predicate Equivalence)Reported Device Performance (N Latex sTfR Reagent)
    CorrelationStrong positive correlation (e.g., r > 0.90) with the predicate device.r = 0.96 with a commercially available sTfR assay.
    Slope (Correlation)Close to 1.0 (indicating similar overall scale).0.81
    Y-intercept (Correlation)Close to 0 (indicating similar bias at low concentrations).-0.19
    Inter-assay PrecisionLow variability (e.g.,
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