LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070064
    Device Name
    AMYLASE EPS REAGENT
    Manufacturer
    Thermo Fisher Scientific
    Date Cleared
    2007-05-22

    (137 days)

    Product Code
    JFJ
    Regulation Number
    862.1070
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMYLASE EPS REAGENT

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

    The Amylase EPS Reagent is used for the quantitative determination of a-Amylase (1,4-α-D-glucan glucanohydrolase EC3.2.1.1) in human serum, plasma or urine on Beckman Coulter SYNCHRON CX ®/ LX ® Systems. a-Amylase is most frequently measured in the diagnosis of acute pancreatitis, when serum levels may be grossly elevated.

    Device Description

    Amylase EPS Reagent

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Thermo Fisher Scientific regarding the "Amylase EPS Reagent." This document confirms the substantial equivalence of the device to a legally marketed predicate device.

    However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval letter, not a scientific study report.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and mentions the intended use of the reagent (quantitative determination of α-Amylase in human serum, plasma, or urine for diagnosis of acute pancreatitis), but it does not detail any performance metrics, study designs, sample sizes, or ground truth methodologies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1