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    K Number
    K071580
    Device Name
    AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
    Manufacturer
    THERMO FISHER SCIENTIFIC OY
    Date Cleared
    2007-10-03

    (117 days)

    Product Code
    CIT,JIX,JJY
    Regulation Number
    862.1100
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K992136
    Why did this record match?
    Device Name :

    AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

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

    The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

    Auxiliary product: Pyridoxal Phosphate
    Auxiliary reagent for in vitro diagnostic use in the quantitative determination of ALT (GPT) and AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.

    For eCal Calibrator, Nortrol and Abtrol see intended use.

    Device Description

    Not Found

    AI/ML Overview

    The provided submission describes an in vitro diagnostic device (IVD) for the quantitative determination of aspartate aminotransferase (AST/GOT) activity. It is not an AI/ML powered device, so many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set) are not applicable.

    Here's the breakdown of the acceptance criteria and study information provided for the AST/GOT (IFCC) device:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to those of the predicate device (Bayer ADVIA IMS Aspartate Aminotransferase (AST) assay (K992136)). The goal is to demonstrate "substantial equivalence."

    Attribute / Acceptance Criteria (Implied by Predicate)New Device (AST/GOT (IFCC)) PerformancePredicate Device (Bayer ADVIA IMS AST assay) Performance
    Intended UseFor in vitro diagnostic use in the quantitative determination of aspartate aminotransferase (L-Aspartate: 2-Oxoglutarate Aminotransferase (AST), EC 2.6.1.1) activity in human serum or plasma on T60 instrument.For in vitro diagnostic use in the quantitative determination of aspartate aminotransferase activity in human serum and plasma on the ADVIA Chemistry systems. Such measurements are used mainly to determine the progress and prognosis of patients with myocardial infarction and the diagnosis and monitoring of liver disease.
    Indication for UseThe AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.See intended use.
    Assay Protocol1-reagent method: Modified IFCC reference method (without PyP)
    3-reagent method: IFCC reference method1-reagent method: Modified IFCC
    3-reagent method: IFCC
    Traceability/StandardizationThe AST/ GOT (IFCC) 1-reagent method is traceable to the molar absorbance coefficient of NADH.
    The AST/ GOT (IFCC) 3-reagent method is traceable to the IFCC reference method.The ADVIA AST and AST P5P method standardization is traceable to the IFCC reference method via patient sample correlation.
    Sample TypeSerum, plasma (heparin)Serum, plasma (Li-heparin)
    Reagent StorageReagents in unopened vials are stable at 2...8 °C until the expiration date printed on the label when protected from light.Unopened reagents are stable until the expiration date printed on the product label when stored at 2 - 8°C.
    Expected ValuesMale:
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