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510(k) Data Aggregation

    K Number
    K981474
    Device Name
    CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
    Manufacturer
    SPECTRAL DIAGNOSTICS, INC.
    Date Cleared
    1998-05-07

    (13 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

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

    Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CK-MB, Myoglobin, and Troponin I Rapid Tests. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically quality control materials for cardiac markers. It does not contain information about a study that assesses a device's performance against detailed acceptance criteria in the way described in the prompt.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, expert qualifications, adjudication methods, MRMC studies, or standalone performance) from this document. This letter primarily confirms that the device is substantially equivalent to a previously marketed device and outlines regulatory obligations.

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