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510(k) Data Aggregation

    K Number
    K012820
    Device Name
    AIA-PACK CTNI 2ND-GEN ASSAY
    Manufacturer
    TOSOH MEDICS, INC.
    Date Cleared
    2001-12-14

    (113 days)

    Product Code
    MMI,JIT
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AIA-PACK CTNI 2ND-GEN ASSAY

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

    AIA-PACK cTnl 2nd-Gen is designated for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin I (cTnl) in human heparinized plasma on specific TOSOH AIA System analyzers. Cardiac troponin I measurements are used as an aid in the diagnosis of acute myocardial infarction (AMI).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for an in-vitro diagnostic device, the AIA-PACK® cTNI 2nd Gen Troponin I Assay. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in your prompt. This type of information is typically found in the 510(k) summary or the full submission, which is not included here. The letter only confirms the FDA's decision to allow the device to be marketed.

    Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study design based solely on the provided FDA letter.

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