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510(k) Data Aggregation

    K Number
    K220265
    Date Cleared
    2023-09-24

    (601 days)

    Product Code
    Regulation Number
    862.1117
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ADVIA Centaur**®** NT-proBNPII (PBNPII)

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

    The ADVIA Centaur® NT-proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system.

    In the Emergency Department (ED) and Outpatient (OP) populations, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.

    Device Description

    The ADVIA Centaur® NT-proBNPII (PBNPII) assay kit includes the Primary Reagent ReadyPack and the Calibrator. The Primary Reagent ReadyPack contains Lite Reagent, Solid Phase Reagent, and Ancillary Well Reagent. The Calibrator includes Low and High Calibrators which are lyophilized.

    AI/ML Overview

    The provided document discusses the ADVIA Centaur® NT-proBNPII (PBNPII) assay, an in vitro diagnostic device for measuring N-terminal pro-brain natriuretic peptide (NT-proBNP) to aid in the diagnosis of heart failure in Emergency Department (ED) and Outpatient (OP) populations. The submission aims to demonstrate substantial equivalence to the predicate device, the Roche Elecsys proBNP II assay (K072437).

    Here's an analysis of the acceptance criteria and the studies that support them:


    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with pass/fail values for all performance characteristics. Instead, it presents various performance studies with their results. Based on the "Comparison of Technological Characteristics with the Predicate Device" and the "Performance Characteristics" sections, we can infer some criteria and compare the device's performance.

    Performance CharacteristicAcceptance Criteria (Implied/Predicate)Reported Device Performance (ADVIA Centaur PBNPII)
    Intended UseAid in diagnosis of suspected congestive heart failure.Aid in diagnosis of HF in ED and OP populations with clinical suspicion of new onset or worsening HF.
    MeasurementQuantitativeQuantitative
    TechnologyChemiluminescence immunoassayChemiluminescence immunoassay (1-step sandwich)
    Sample TypePlasma and SerumHuman serum, plasma (EDTA and lithium heparin)
    Assay Range5-35,000 pg/mL (Predicate)35-35,000 pg/mL
    Hook EffectNo hook effect up to 300,000 pg/mL (Predicate)No hook effect up to 300,000 pg/mL (will report >35,000 pg/mL)
    Precision (Total CV)For Serum: e.g.,
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