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    K Number
    K032235
    Device Name
    MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
    Manufacturer
    BIOSITE INCORPORATED
    Date Cleared
    2004-01-28

    (191 days)

    Product Code
    NBC
    Regulation Number
    862.1117
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K020582,K040243,K072703
    Why did this record match?
    Device Name :

    MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

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

    The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of scverity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.

    Device Description

    The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Triage® B-Type Natriuretic Peptide (BNP) Test, structured according to your requested information:

    1. Table of Acceptance Criteria and the Reported Device Performance

    The provided text focuses on the equivalence of capillary whole blood samples to venous whole blood samples for the Triage® BNP Test, rather than specific diagnostic accuracy acceptance criteria (e.g., sensitivity, specificity, AUC). Therefore, the acceptance criteria are related to the comparability of these sample types.

    Acceptance Criteria (Implicit)Reported Device Performance
    Statistical Equivalence: No significant difference (p
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