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    K Number
    K192271
    Device Name
    Access PCT, Access PCT Calibrators
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2019-11-26

    (96 days)

    Product Code
    PTF
    Regulation Number
    866.3215
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K162827
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    Device Name :

    Access PCT, Access PCT Calibrators

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

    The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission to severe sepsis and septic shock.

    The Access PCT Calibrators are intended to calibrate the Access PCT assay for the quantitative determination of procalcitonin levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems.

    Device Description

    The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progressive to severe sepsis and septic shock.

    A description of the reagent pack is provided below.

    • R1a: Dynabeads* paramagnetic particles coated with mouse anti-human ● Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300
    • R1b: 0.10 N Sodium Hvdroxide ●
    • R1c: MOPS Buffer with surfactant and protein (bovine, murine). ≤ 0.1% . sodium azide, and 0.1% ProClin 300
    • R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase conjugate in a ● MOPS buffer with surfactant and protein (bovine, murine, recombinant), ≤ 0.1% sodium azide, and 0.1% ProClin 300
    AI/ML Overview

    This document describes the acceptance criteria and study results for the Beckman Coulter Access PCT assay, which measures procalcitonin (PCT) levels in human serum and plasma to aid in the risk assessment of critically ill patients for severe sepsis and septic shock.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance CriteriaReported Device Performance
    Method ComparisonSlope = 0.90 ± 0.10 relative to predicate (VIDAS® B·R·A·H·M·S PCT®)Slope = 0.96 (95% CI: 0.94 to 0.99)
    Correlation Coefficient (r) ≥ 0.95r = 0.99
    ImprecisionTotal imprecision ≤ 8.0% CV at concentrations ≥ 0.150 ng/mL; SD ≤ 0.012 ng/mL at concentrations
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