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510(k) Data Aggregation

    K Number
    K030057
    Device Name
    SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
    Manufacturer
    SPECTRAL DIAGNOSTICS, INC.
    Date Cleared
    2003-03-19

    (71 days)

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

    SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

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

    For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, pointof-care, and hospital settings.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test." This document is an approval letter and an "Indications for Use" statement, not a study report or clinical trial summary.

    Therefore, it does not contain the acceptance criteria or the study details requested in your prompt. It only states that the device is substantially equivalent to legally marketed predicate devices and outlines its intended use.

    To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for this device, which are not provided in the input text.

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