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510(k) Data Aggregation

    K Number
    K190807
    Device Name
    VITROS XT Chemistry Products TBIL-ALKP Slides
    Manufacturer
    Ortho-Clinical Diagnostics, Inc.
    Date Cleared
    2019-04-26

    (28 days)

    Product Code
    CIG,CJE
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITROS XT Chemistry Products TBIL-ALKP Slides

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

    Rx Only For in vitro diagnostic use only

    The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal destruction of red blood cells, are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.

    The ALKP test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically for VITROS XT Chemistry Products TBIL-ALKP Slides. The provided text is a regulatory communication and does not contain the acceptance criteria or study details for the device's performance.

    To answer your request, I would need access to the actual 510(k) summary, often referred to as a "510(k) Premarket Notification." This document typically includes the performance data, acceptance criteria, and study designs to demonstrate substantial equivalence to a predicate device.

    The information you've provided only states:

    • Device Name: VITROS XT Chemistry Products TBIL-ALKP Slides
    • Intended Use: Quantitative measurement of total bilirubin (TBIL) and alkaline phosphatase (ALKP) in serum and plasma using VITROS XT 7600 Integrated Systems.
    • Regulatory Class: Class II
    • Product Code: CIG (Bilirubin (total or direct) test system), CJE (Alkaline phosphatase test system)
    • Date of Clearance: April 26, 2019

    Without the 510(k) summary or a similar technical document, I cannot extract the specific acceptance criteria, study details, sample sizes, or ground truth information you've requested.

    Therefore, I cannot provide the requested table and study details based solely on the provided text.

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