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    K Number
    K051596
    Device Name
    STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
    Manufacturer
    NANOGEN, INC.
    Date Cleared
    2006-03-13

    (270 days)

    Product Code
    NBC
    Regulation Number
    862.1117
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K032646
    Why did this record match?
    Device Name :

    STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204

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

    StatusFirst™ CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF.

    Device Description

    The StatusFirst™ CHF NT-proBNP test device utilizes biotin coupled anti-NTproBNP antibody/streptavidin solid-phase chromatographic immunoassay technology to quantitatively determine the concentration of NT-proBNP in human EDTA plasma. After a sample has been dispensed into the sample well, the StatusFirst™ CHF NTproBNP test device is placed in the DXpress™ Reader. The DXpress™ Reader displays the NT-proBNP concentration 15 minutes after sample addition. The DXpress™ Reader is programmed to automatically convert the intensity of the test band (as indicated by the "pBNP" line on the test device) into a concentration of NTproBNP by using lot specific calibration factors supplied with each box of 20 StatusFirst™ CHF NT-proBNP test devices. The NT-proBNP concentration in the sample correlates with the intensity of the test band.

    AI/ML Overview

    The provided document describes a 510(k) premarket submission for the StatusFirst™ CHF NT-proBNP device, which measures NT-proBNP levels for aid in CHF diagnosis. The study described is a method comparison study intended to demonstrate substantial equivalence to a predicate device, the Roche Elecsys® proBNP Immunoassay.

    Here's an analysis of the provided information according to your requested categories:

    Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly list "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents the results of a method comparison study against a predicate device, aiming to demonstrate substantial equivalence. The "reported device performance" is primarily shown through the correlation between the StatusFirst™ device and the predicate.

    Acceptance Criteria (Implied by Substantial Equivalence to Predicate)Reported Device Performance (StatusFirst™ CHF NT-proBNP vs. Elecsys® proBNP)
    Good correlation for CHF subjects (compared to predicate)Spearman Rank correlation: 0.922 (n = 324)
    Good correlation for non-CHF subjects (compared to predicate)Spearman Rank correlation: 0.948 (n = 324)
    Good correlation for all subjects combined (compared to predicate)Spearman Rank correlation: 0.973 (n = 648)
    Agreement in measuring range (though predicate has wider range, the functional range of the new device should be clinically useful and comparable)StatusFirst™ Measuring Range: 20-5,000 pg/mL
    Elecsys® proBNP Measuring Range: 5-35,000 pg/mL (StatusFirst™ falls within a relevant clinical range)
    Functional Sensitivity (comparable to predicate)StatusFirst™ Functional Sensitivity: 20 pg/mL
    Elecsys® proBNP Functional Sensitivity:
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