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    K Number
    K231974
    Device Name
    PATHFAST®hs-cTnI-II
    Manufacturer
    PHC Corporation
    Date Cleared
    2024-03-20

    (261 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K100130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHC Corporation

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

    PATHFAST® hs-cTnl-II is an in vitro diagnostic test for the quantitative measurement of cardiac Troponin I (cTnl) in heparinized or EDTA whole blood and plasma. Measurements of cardiac Troponin I are used as an aid in the diagnosis of acute myocardial infarction (AMI). PATHFAST® hs-cTnI-II is for use in clinical laboratory or point of care (POC) settings.

    Device Description

    The PATHFAST® hs-cTnI-II test is a chemiluminescent enzyme immunoassay performed on the PATHFAST® instrument. Patient samples, whole blood or plasma, are dispensed by the operator into the designated area on the reagent cartridge. The instrument combines the patient sample, the antibody coated magnetic particles, and the alkaline phosphatase conjugate and incubates the mixture for 5 minutes at 37℃. During this incubation, the analyte in the patient sample binds to the antibody on the coated particles, and the alkaline phosphatase conjugate binds to the analyteantibody coated-particle. After the incubation, the instrument performs Bound/Free (B/F) separation using Magtration® technology to remove any excess unbound reagents. The chemiluminescent substrate is then added. The substrate is catalyzed by the bound alkaline phosphatase, which results in emission of photons. The photo-multiplier tube in the PATHFAST® instrument detects the photons that are emitted during the reaction. The chemiluminescent count is converted to analyte concentration values by the instrument based on the master calibration curve for the reagent lot. The PATHFAST® hs-cTnI-II test is supplied in reagent kits. Each kit contains sufficient materials for 60 determinations. The calibrator materials are included with the reagent kit and are also available separately. Calibration kits and diluent kits are also provided separately.

    AI/ML Overview

    The provided text describes the regulatory clearance of the PATHFAST® hs-cTnI-II device, a diagnostic test for cardiac Troponin I (cTnI), and its comparison to a legally marketed predicate device (PATHFAST® cTnI-II, K100130). The focus of this document is on the analytical performance and how modifications to the reporting range do not affect clinical performance, relying on data from the predicate device.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this device, the "acceptance criteria" are tied to its analytical performance and how it meets the claims for its intended use, especially concerning linearity, detection limits, and maintaining the clinical significance established by the predicate.

    Acceptance CriterionReported Device Performance (PATHFAST® hs-cTnI-II)
    Linearity/Reportable RangeLinearity for the interval from 4.1 to 50,000 ng/L, with deviations from linearity within ±10%. (Maximum absolute deviation observed was 9.7%).
    Limit of Blank (LoB)1.466 ng/L (for EDTA WB, Plasma, LiHep WB, LiHep Plasma)
    Limit of Detection (LoD)2.991 ng/L (EDTA WB), 2.958 ng/L (EDTA Plasma), 2.942 ng/L (LiHep WB), 3.002 ng/L (LiHep Plasma)
    Limit of Quantitation (LoQ)4.1 ng/L (for EDTA WB, Plasma, LiHep WB, LiHep Plasma) - defined as the minimum cTnI concentration with % CV
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