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510(k) Data Aggregation

    K Number
    K080485
    Device Name
    ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
    Manufacturer
    DIASYS DIAGNOSTICS SYSTEMS GMBH
    Date Cleared
    2008-12-04

    (286 days)

    Product Code
    CIT,JIT,JJX
    Regulation Number
    862.1100
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k924244,k990460,k042389
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASYS DIAGNOSTICS SYSTEMS GMBH

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

    The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.

    For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay.

    For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.

    Device Description

    The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown in the following equation:

    L-Aspartate + 2-Oxoglutarate L-Glutamate + Oxalacetate

    Oxalacetate + NADH + H' L-Malate + NAD*

    Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the transaminases and avoids falsely low values in samples containing insufficient endogenous P-5-P, e.g. from patients with myocardial infarction, liver disease and intensive care patients .

    TraCal U calibrator-Serum based calibrator for use in the calibration of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

    Trulab N and TruLab P controls-Serum based control serum in normal and pathological range for use in quality control for monitoring accuracy and precision of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.

    AI/ML Overview

    The furnished document is a 510(k) premarket notification for an in vitro diagnostic device, the DiaSys ASAT (GOT) FS assay, TruCal U calibrator, and TruLab N and TruLab P controls. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive independent clinical study data with predefined acceptance criteria as might be seen for novel devices.

    Therefore, the information regarding acceptance criteria and a detailed study proving the device meets these criteria is limited and primarily presented in the context of comparison to the predicate device.

    Here's the breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" for the studies in the same way a clinical trial would. Instead, it presents performance characteristics and compares them to the predicate device, implying that equivalence to the predicate's performance is the de facto acceptance criterion.

    CharacteristicAcceptance Criteria (Implied)Reported Device Performance (DiaSys ASAT (GOT) FS assay)
    Intended UseEquivalent to predicate device.The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. (Similar to predicate, though predicate includes EDTA plasma).
    Assay ProtocolEquivalent to predicate device.2-reagent method: modified IFCC reference method (without P-5-P) or 2-reagent method: IFCC reference method (P-5-P concentrate mixed into R1). (Similar to predicate, predicate uses P-5-P tablet).
    TraceabilityStandardized against IFCC formulation.Standardized against the original IFCC formulation with and without pyridoxal phosphate. (Same as predicate).
    Reagent StorageComparable shelf life and on-board stability to predicate.Storage: 2-8°C, Shelf Life R1 - 15 months, R2 - 15 months, P-5-P - 24 months. On Board R1(no P-5-P) - 4 weeks, R1(with P-5-P) - 6 days, R2 - 4 weeks. (Comparable but some differences to predicate).
    InstrumentHitachi 917.Hitachi 917. (Same as predicate).
    Measuring RangeComparable to predicate device.7-700 U/L. (Predicate: 4-800 U/L).
    Expected ValuesConsistent with clinical understanding and predicate device.With P-5-P activation: Women
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